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The primary objective of this pilot study was to explore the feasibility of implementing two exercise programs for female patients who are breast cancer survivors and residents of the metropolitan area of San Juan, Puerto Rico. Potential benefits and complications of participating in a gym-exercise program or a home-exercise program, as opposed to standard care, were identified. Participants were randomly assigned to 1 of 3 groups: a gym-exercise group, a home-exercise group, or a non-exercise group. Interventions consisted of exercise programs with both aerobic and strengthening components, offered for a 26-week period. Outcome measures consisted of functional evaluation, shoulder range of motion, 12-minute walk test, handgrip strength, body mass index, and quality of life. The results of this study showed that it is feasible for Puerto Rican women to participate in a moderate intensity exercise program without developing complications. Participation in the exercise programs studied here minimized the side effects after cancer treatment, such as reduced physical functional ability and restricted shoulder mobility. Improvements were found in the measures of shoulder range of motion, upper extremity related physical function, and distance walked.
Recent investigations are challenging the validity of traditional advice of limited activity for breast cancer patients, since these recommendations have not been substantiated by research. Harris and Niesen-Vertommen1 reported on 20 women who had axillary lymph node dissection or adjuvant therapy, or both, who participated at a competitive level in the sport of dragon boat racing, involving vigorous upper extremity exercise. Their findings indicated that none of these women developed lymphedema after competing in this strenuous sport; calling into question whether the traditional exercise recommendations for breast cancer patients could result in optimal benefits. Lane, Jespersen, and McKenzie2 reported the effect of a 20-week exercise program consisting of aerobic and resistance exercise, combined with dragon boat training, on 16 women who were breast cancer survivors. No complication of lymphedema was reported; a positive outcome of increased upper extremity strength was found. These results strongly suggest that moderate exercise after breast cancer does not lead to the development of complications such as lymphedema.
Recently published research indicates that the benefits of vigorous exercise in this patient group might outweigh the potential risk of lymphedema or any other risk considered. A review of the literature on the benefits of moderate intensity exercise for breast cancer survivors points to its many positive effects: improved aerobic endurance, strength, physical function, emotional well being, and weight control; decreased insomnia and fatigue; and an enhanced immunological system, among other benefits.3-5 Based on these findings, exercise guidelines for women with breast cancer have been delineated.6
Na and colleagues7 reported on the effects of an early rehabilitation program after mastectomy, beginning the first postoperative day. Intervention consisted of postural exercises, range of motion exercise, and training on functional activities. Compared to the control group, the experimental group demonstrated significant improvements in range of motion and functional assessment. No increased postoperative complications were shown in the experimental group. Similar results had been reported by Wingate8 and Wingate and colleagues.9
Segal and colleagues10 studied the effects of a rehabilitation program for oncology patients on quality of life, functional performance, and psychosocial adjustment. Researchers found that subjects with a variety of cancers and at different illness stages were able to complete the program, with not a single adverse event recorded. Subjects in this study reported an increased sense of control and increased involvement in their cancer treatment. The most significant outcome of this study was that it evidenced that an individualized exercise program does not induce health complications for cancer patients.
In 2001, Segal and colleagues11 reported on the effects of a randomized controlled trial on physical function and quality of life of women with breast cancer at stages I and II, divided into 3 groups were compared: usual medical care, self-directed exercise, and supervised exercise. At the end of the 26-week intervention period, subjects in both self-directed and supervised exercise groups showed significant changes in their physical functioning, as compared to the control group. No significant differences were observed in quality of life scores. The results of this study indicate that exercise is beneficial in improving physical function in breast cancer survivors.
According to the American Cancer Society,12 over 211,000 new cases of invasive female breast cancer will be diagnosed in the United States in the year 2005. In Puerto Rico, the estimated incidence of female breast cancer for the year 2002 was 1,380 cases.13 Improvements in breast cancer early detection and treatment have led to a 3.3% annual decrease in cancer mortality for women younger than 50, and 2.0% for women 50 and older, from 1990 to 2002 on the mainland of the United States. These statistics show that the number of breast cancer survivors has increased--a tendency that is expected to continue.12 Intervention strategies for female patients who are breast cancer survivors gain importance in view of such statistics.
The main objective of this study was to explore the feasibility of implementing 2 different exercise programs for female patients who are breast cancer survivors in Puerto Rico by determining the potential benefits and complications. One exercise program was provided at a gym, similar to successful programs elsewhere,3,10,11 but combined both an aerobic program and a strengthening program. The second exercise program consisted of exercising in the participant’s home or out of doors in the neighborhood as a low-cost alternative for exercise at a gym.
A convenience sample of 44 women was used. All women had a new diagnosis of unilateral breast cancer and had received surgical treatment for breast cancer within the past 5 years, with or without adjuvant therapy, was recruited.
Adjuvant therapy had already been completed at least 2 months prior to their enrollment in the study. Participants were residents of Puerto Rico. Exclusion criteria were: unstable cardiac disease; coagulopathies; active psychiatric conditions; metastasis, hemoglobin level less than 8.0 g/dL; absolute neutrophil count less than 0.5 times 1,000/ML, platelet count less than 50 times 1,000/ML, ataxia, dizziness, or peripheral sensory neuropathy, loss of more than 35% of premorbid weight, dyspnea, bone pain, severe nausea, extreme fatigue, and extreme muscle weakness. Exclusion criteria are considered contraindications to moderate intensity exercise program following cancer diagnosis.3,10
Participants were recruited during a 3-year period (2004 thru 2007) through the use of advertisements in newspapers, radio, television, magazines and institutional intranet, announcements on bulletin boards, through visits to physician’s offices, and participation in survivorship activities. The study protocol was approved by the Institutional Review Board at the Medical Sciences Campus, University of Puerto Rico. Those who met the selection criteria were scheduled for a medical evaluation and a CBC with differential test, in order to confirm compliance with selection criteria and absence of contraindications to participate in the exercise program.
The design of this study was a multigroup pretest-posttest control-group, where participants were evaluated 3 times: at baseline, at week 13, and at the completion of the intervention on week 26.
Outcome measures for this study were: functional evaluation, shoulder range of motion, 12-minute walk test, handgrip strength, body mass index, and quality of life. These outcome measures have been selected as they examine the most common morbidities after breast cancer surgery and treatment, that is, increased weight, negative effects on quality of life, and upper extremity’s loss of function, weakness, edema, and decreased range of motion.6,14
Function was measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.5 The DASH questionnaire is a self-reported measure on physical function and social role function. The total score can range from 0 to a maximum of 100; where the lower scores indicate less disability. The instrument is available in Spanish for Puerto Rico.16
Shoulder range of motion was examined, as reduced mobility has been reported as a common sequel of mastectomy.17 Shoulder flexion, abduction, and external rotation were examined through goniometry, as these motions have been reported as affected after breast cancer treatment.18
The 12-minute walk test has been validated to assess exercise tolerance.19 The 12-minute walk test has also been recommended as a test suitable for fitness, as it is highly correlated with oxygen uptake.20 This is a performance test wherein participants were asked to walk for 12 minutes, and the distance was recorded in feet. An increase in walking distance indicates an improvement in performance.
Handgrip strength was examined using a hand-held dynamometer. Participants were evaluated in a seated position, with the arm resting at the side with the elbow flexed at 90°, and the forearm in mid-position between pronation and supination. Grip size was adjusted to a comfortable position for the grip, with the handle placed between the second or third spacing. Participants were instructed to squeeze as hard as possible. Two trials were performed, and the highest score used. Both hands were tested. Information on the dominant side was recorded.
Body mass index was calculated using the formula: weight (lb)/ [height (in)]2 × 703.21 Weight was examined using a scale with subjects wearing light clothing and no shoes; height was measured with a fixed wall-mounted ruler.
A Spanish version of the Functional Assessment of Cancer Therapy – B (FACT-B) was also administered. This measure has been developed for patients with breast cancer. It measures self-reported health related quality of life according to 5 dimensions: physical well-being, social/family well-being, emotional well-being, functional well-being, and concerns related to breast cancer, using a 5-point scale. An increase in score indicates a higher quality of life.22
In addition, volumetric measurements were collected to monitor the development of lymphedema, a potential side effect of breast cancer treatment. Volumetric measurements were collected using a volumetric edema gauge, following the procedures outlined by Megens and colleagues.23 Water displacement volumetry has been reported to provide an accurate estimate of volume of the upper extremity in women at risk for lymphedema after axillary node dissections.23 Volumetric measurements of the entire arm were collected with the participant in a seated position. A mark was made at the level of 15.0 cm proximal to the lateral epicondyle on both upper extremities. The extremity was immersed slowly into a large chamber with the elbow straight, until the water level reaches the 15.0 cm mark proximal to the lateral epicondyle. The arm was held in that position until the water flows at a rate of less than 1 drop per second. The displaced water was measured with the graduated cylinder to determine the volume of the entire arm. The non-involved upper extremity was measured first in each participant. Inter-rater and test-retest reliability for volumetric measurements has been reported at 0.99.23 A difference in volume equal or greater than 200.0 cm3 was considered lymphedema.24
One physical therapist, blinded to group assignment, evaluated the participants in this study. Participants were instructed not to discuss their exercise programs or group assignment with the evaluator. The evaluator administered the questionnaires for physical function and quality of life, and collected data on weight, the 12-minute walk test--including heart rate, oxygen saturation, and perceived exertion, shoulder range of motion, handgrip strength, and volumetric measurements. The evaluator was trained prior to data collection. To evaluate test-retest reliability, measurements were collected on 10 normal subjects during an initial evaluation, and again one week later. Intraclass correlation coefficient was used to analyze reliability. An acceptable level of reliability of no less than 0.80 was achieved for the measurements on weight, the 12-minute walk test, handgrip strength, and volumetric measurements. Shoulder range of motion measurements did not meet the 0.80 cutoff for reliability. To improve reliability, the evaluator and the program coordinator met with additional volunteers to review the protocol for range of motion measurements, including positioning of the subject, alignment of the goniometer, and goniometric reading.
To evaluate attendance to the gym-exercise program, subjects were asked to sign an attendance log every day they visited the gym and performed their exercise routine during the 26-week period. To evaluate attendance for the home-exercise group, data was collected weekly on program adherence through weekly follow-up calls. Participants in the home-exercise group were asked to keep a log about their performance in the exercise program and they provided the log at their monthly visit.
After subject recruitment and obtaining the informed consent, a blood sample was collected to evaluate inclusion criteria, followed by an evaluation from the oncologist. The Spanish version of instructional materials published by the National Institute of Cancer25 was given to all participants. During the initial session, participants were scheduled for an appointment with the evaluator for baseline measurements. During the initial evaluation, each participant’s sociodemographic and clinical data was collected.
Once baseline measurements were obtained, participants were randomly assigned to 1 of 3 groups: gym-exercise group, home-exercise group, or standard-care control group. Randomization of participants was performed using a computer-generated scheme developed with the Statistical Analysis System.26 Participants in both the gym-exercise group and the home-exercise group met with the study staff (physical therapists) for training in their assigned exercise program. Exercise intensity and progression were based on the subject’s physical status (aerobic status and strength). Subjects in both the gym-exercise group and the home-exercise group performed 2 resistance training sessions and 3 aerobic training sessions per week for 26 weeks. All participants followed the same exercise protocol for the group they were assigned.
The staff met with the participants in the gym-exercise program once a week for exercise supervision and progression. The gym had qualified personnel who were present to assist the participants during their exercise routine for the other days of the week where on-site supervision from the study staff was not provided.
Participants in the home-exercise group met with the staff (physical therapists) once a week, for the first 3 weeks. Thereafter, they met once a month to monitor and progress the exercise program, in terms of walking and resistance intensity. A weekly telephone call by the program coordinator was made to evaluate attendance, as well as to answer questions and address concerns regarding their home-exercise program.
All participants in the home- and gym-exercise programs were taught flexibility exercises to be performed as part of the warm-up and cool-down procedures. They were provided with an illustrated brochure in Spanish explaining each flexibility exercise. They were supervised, as described above, in the performance of the flexibility exercises.
The control group continued receiving the usual care provided by their physicians. At the end of their participation in the study, the control group was offered an orientation session on the benefits of participating in an exercise program, along with the exercise brochures for home exercises and elastic bands.
Treatment protocol for the gym-exercise group followed the guidelines established by Courneya, Mackey, and McKenzie.6 For the aerobic exercise component, participants were asked to walk on the treadmill for a period of 30 minutes, 3 times per week, at the gym, at an intensity of 60% to 80% of maximum heart rate (HR max). HR max was calculated by using the formula for age-predicted maximal heart rate for the general population: 220 minus participant’s age.27 At the gym, heart rate was monitored using the built-in heart rate monitor feature of the treadmill (Cybex treadmill model 700T); participants were also taught to self-monitor their heart rate during exercise. Initially, deconditioned participants required shorter periods of walking with rest intervals.
For the resistance exercise component at the gym, both stretching and weight training exercises were included. Participants stretched 7 to 10 minutes before and after each workout. Resistance training was performed twice a week. Exercises targeted muscle groups of the chest, back, upper extremities, abdomen, and lower extremities. Weight training exercises were performed mainly with weight-training machines, and when participants experienced difficulty with the machines, free weights were used. Resistance exercises were performed 2 times per week. For the first 2 weeks, as an introductory period, participants began using a very light weight to establish proper handling of equipment, allow time for muscle adaptation, and practice good technique, as recommended by Kemmler and colleagues28 and Pollock and colleagues.29 At week 3, resistance was set at a moderate level to allow the participant to achieve 10 repetitions at a comfortably hard level based on the Borg scale of perceived exertion—13 to 15 on the Borg scale of 6 to 20.29 Two sets of 10 repetitions of each exercise were performed; then they were increased to 2 sets of 15 repetitions. Once the participant was comfortable with 2 sets of 15 repetitions, it was again increased to 3 sets of 15 repetitions. Only after this increase in repetitions was achieved, was the resistance increased by 5% for the next training session.29 Each time the resistance was increased, the number of sets was decreased to 2 and progressed as before.
Treatment protocol for the home-exercise group also included aerobic and resistance components. The aerobic exercise component was provided through a walking exercise program performed in the participant’s neighborhood, such as walking in the streets or a park. Participants walked 3 times per week at an intensity based on the rate of perceived exertion. This is a method suggested by the American Heart Association.30 Individuals were instructed to adhere to a rate of perceived exertion from 12 to 16 (somewhat hard to hard) on the Borg scale of 6 to 20. Similar to the gym group, deconditioned participants required shorter periods of walking with rest intervals. All participants achieved the 30-minute duration, at the set intensity.
The resistance exercise component for the home group was provided using elastic bands (Theraband), and was to be performed twice a week. Participants in the home-exercise program were asked to keep a log, specifying their performance for each day that they exercised. Both stretching and resistance training exercises were included. Participants stretched 7 to 10 minutes before and after each workout. Exercises targeted the chest, back, upper extremities, abdomen, and lower extremities muscle groups. Elastic bands were used to provide individualized levels of resistance. Resistance exercises were performed 2 times per week. For the first 2 weeks, as an introductory period, participants began using very light resistance, to allow time for muscle adaptation and practice good technique, as recommended by Kemmler and colleagues28 and Pollock and colleagues.29 At week 3, resistance was increased at a moderate level that allowed the participant to achieve 2 sets of 10 repetitions at a comfortably hard level based on the Borg scale of perceived exertion—13 to 15 on the Borg scale of 6 to 20.29 Then repetitions were increased to 15,2 sets. Initial progression was achieved by increasing the number of repetitions per set. Once the participant was comfortable with 2 sets of 15 repetitions, the physical therapist increased it to 3 sets of 15 repetitions. Only after this increase in repetitions was achieved, was the resistance increased by providing bands of increased thickness. Each time the resistance was increased, the number of sets was decreased to 2 and progressed as before. For the at home resistance component, participants followed a detailed brochure in Spanish that included illustrations for each exercise.
Descriptive statistics were computed to describe baseline demographic and medical data. Frequency distribution and percentages were obtained for categorical variables.
The Wilcoxon signed ranks test was employed to compare the scores on functional evaluation, 12-minute walk test, handgrip strength, shoulder range of motion, body mass index, and quality of life within each comparison group (gym-exercise group, home-exercise group, and non-exercise group) from baseline to completion of the intervention.
Analysis of variance using the Kruskal Wallis test was employed to compare score means difference (between baseline and week 26 on outcome measures between comparison groups (gym-exercise group, home-exercise group, and non-exercise group). However, the one-way ANOVA test gave consistent results with the Kruskal Wallis method. Multiple comparisons using the Bonferroni’s method were used to determine which pair of means was statistically significant between the groups. The level of significance was set at p < 0.05. Statistical analyses were performed using SPSS version 13.0 for Windows.31
Forty four women were recruited for this study. Ten participants left the study: 4 from the gym exercise group and 6 from the home exercise group. Reasons for discontinuation in the program for gym based and home based subgroups are presented in Table 2.
For the 34 participants who completed the study, their ages ranged from 34 to 84 years; mean age was 52.9 years. The non-exercise group had a mean age of 59.6 years, the gym exercise group of 49.8 years, and the home exercise group of 51.1 (p=0.29, Welch’s ANOVA). In the 3 comparison groups, the most frequently reported type of surgery was lumpectomy, being performed in 44.4% of the non-exercise group, 50.0% of the gym-exercise group, and 61.5% of the home-exercise group. In addition, lymph node dissection was performed in 55.6% of the non-exercise group, 83.3% of the gym-exercise group, and 92.3% of the home-exercise group. Additional characteristics of the study groups are presented in Table 1.
Results of changes within groups for the 3 evaluation sessions are presented in Table 3. In the non-exercise group, there was an increase in the self-reported disability (as per the Disabilities of the Arm, Shoulder, and Hand [DASH] questionnaire – Spanish version) from a score of 18.0 ± 12.5 to a score of 20.8 ± 15.5 from baseline to end of the study period. This increase was not statistically significant (p = 0.89). Conversely, a decrease in the self-reported disability were observed in the gym group (from a score of 26.0 ± 20.6 to a score of 21.8 ± 23.0) and in the home group (from a score of 26.0 ± 15.1 to a score of 19.4 ± 18.2) after completion of the intervention. However, in both groups the decrease was not statistically significant (p=0.17 for the gym group; p=0.06 for the home group). Figure 1 shows the comparison between groups; no statistical differences were observed after completion of the intervention (p = 0.17).
For flexion range of motion, in the non-exercise group, a small increase from 167.9 ± 18.7° to 168.3 ± 15.2° was observed from baseline to end of study period. This increase was not statistically significant (p = 0.34). Conversely, increases in shoulder flexion were observed in the gym group (from 160.6 ± 31.7° to 169.3 ± 28.1°) and home group (from 164.3 ± 30.1° to 176.2 ± 5.5°), after completion of the intervention. However, statistical differences were observed only in the gym group (p = 0.04). No statistical difference for the home group was found (p = 0.05). Figure 2 shows the comparison between groups; no statistical differences were observed after completion of the intervention (p = 0.45).
For abduction range of motion, in the non-exercise group, a nonsignificant increase (p = 0.13) from 150.0 ± 30.2° to 161.2 ±28.7° was observed from baseline to end of study period. In addition, an increase in shoulder abduction from baseline to completion of the intervention were observed in the gym group (from 144.0 ± 41.8° to 158.0 ± 42.0°) and home group (from 143.5 ± 41.2° to 164.6 ± 21.8°), but differences were not statistically significant (p = 0.11 for the gym group; p = 0.06 for the home group). Figure 3 shows the comparison between groups; no statistical differences were observed after completion of the intervention (p = 0.70).
For external rotation range of motion, in the non-exercise group, a nonsignificant decrease (p = 0.08) from 80.7 ± 17.8° to 71.9 ± 24.6° was observed from baseline to end of study period. Conversely, a statistically significant increase in external rotation were observed in the gym group (from 70.8 ± 28.9° to 86.9 ± 7.0°; p = 0.02) and home group (from 75.9 ± 18.8° to 86.2 ± 11.0°; p = 0.03) after completion of the intervention. Figure 4 shows the comparison between groups. Statistical differences among groups were found after completion of the intervention (p = 0.01). Post hoc analysis revealed significant improvements among the gym (p = 0.02) and home (p = 0.01) groups when compared to the non-exercise group.
In the 12-minute walk test, the non-exercise group showed a decrease in distance from 2470.7 ± 681.9 feet to 2416.1 ± 718.6 feet from baseline to end of study period. This decrease was not statistically significant (p = 0.83). Conversely, an increase in the distance was observed in the gym group (from 2698.8 ± 838.4 feet to 2966.5 ± 390.7 feet), and home group (from 2663.8 ± 484.8 feet to 3044.3 ± 440.9 feet) after completion of the intervention. However, statistical differences were observed only in the home group (p = 0.01 for the home group; nonsignificant p = 0.22 for the gym group). Figure 5 shows comparisons between groups; no statistical differences were observed after completion of the intervention (p = 0.31).
Handgrip strength decreased or remained almost the same among the 3 groups. There were no effects in body mass index among the 3 groups. In the non-exercise group, there was a decrease in the self-reported quality of life (as per the Functional Assessment of Cancer Therapy-B [FACT-B]) from a score of 109.9 ± 18.2 to a score of 91.6 ± 28.5 from baseline to end of study period. This decrease was not statistically significant (p = 0.09). Conversely, an increase in the self-reported quality of life was observed in the gym group from a score of 106.4 ± 20.9 to a score of 109.8 ± 25.2 after completion of the intervention. The difference was not statistically significant (p > 0.37). On the other hand, a decrease in the self-reported quality of life was reported in the home group from a score of 117.4 ± 28.3 to a score of 104.8 ± 32.1 after completion of the intervention. This decrease was not statistically significant (p > 0.88). Figure 6 shows comparisons between groups; no statistical differences were observed after completion of the intervention (p = 0.24).
Participants in both the gym and home exercise programs were expected to perform endurance training 3 times a week for 26 weeks (total of 78 sessions in 26 weeks) and strengthening training twice a week for 26 weeks (total of 52 sessions in 26 weeks). For the endurance training, all participants achieved the 30-minute duration at the set intensity.
Twelve women completed the gym exercise program. Participation in the aerobic sessions ranged from 19 to 54 (a mean of 37 sessions) for a percentage of participation ranging from 24% to 69%. Participation in the strengthening sessions ranged from 12 to 46 (a mean of 33 sessions), for a percentage of participation ranging from 23% to 88%. During the last months of the project, the gym underwent remodeling and participants complained of dust at the gym, making breathing difficult for them during walking. Three participants were accommodated to continue the aerobic training through group participation in aquaerobics-aerobic exercises in the gym pool. Their participation in these sessions was accounted as participation in the endurance training.
Thirteen women completed the home exercise program. Endurance participation ranged from 27 to 69 sessions completed (a mean of 55 sessions); percentage of participation ranged from 35% to 88%. Participation in the strengthening sessions ranged from 18 to 57 (a mean of 45 sessions); percentage of participation ranged from 35% to over 100%, as 2 participants performed more than the recommended 2 strengthening sessions per week.
Reasons given for not completing all the expected exercise sessions in both groups were: lack of time, travel, illness of herself or a family member that required her time to nurse them back into health, and pain in the shoulder or the trunk (ribs, spine).
One of the major goals of this study was to determine potential complications of participating in a gym-exercise program or a home exercise program. As lymphedema is a major complication following breast cancer surgery and treatment, development of lymphedema was monitored on the 3 evaluation sessions each participant had. None of the women had lymphedema prior to enrollment in the study and no participant developed it during the course of the study.
One participant developed an asthma episode during the 12-minute walk test at baseline evaluation. This participant had a past history of asthma and thought it was under control. At baseline evaluation, the 12-minute walk test was discontinued and the participant was taken to urgent care for treatment. She communicated her inability to participate in the study afterwards due to recurrence of uncontrollable asthma episodes.
Another participant had an episode of hypoglycemia while at the gym during an exercise session in the morning, due to skipping breakfast. She was given a snack right there at the gym and an orientation afterwards on hypoglycemia and its implications. She was referred to the Diabetes Clinic at the Medical Sciences Campus of the University of Puerto Rico, however, she did not attend. Nevertheless, this incident was never repeated.
Three participants presented high blood pressure (above 140/90 mm Hg) during their participation in the exercise programs. One participant in the gym exercise group had an episode of high blood pressure after taking a medication to control coughing. A participant in the home exercise group had another episode due to stress related to family issues; she decided to discontinue her participation in the program for these reasons. A third participant from the home exercise group had an episode of high blood pressure and was referred to a cardiologist; she did not have the financial resources to pay for the cardiologist evaluation and was not able to continue in the study.
One participant from the gym exercise group complained of severe headache at the second evaluation session, after 3 months of participating in the program without any symptoms. She also commented that she was recently asked to leave her job, which we suspected could be a source of stress headaches. She was referred by the oncologist to the cardiologist for further evaluation; however, she was unable to pay for the visit of the cardiologist and was unable to return to the study. Finally, a participant in the gym exercise group complained of foot pain prior to beginning her participation in the exercise program. After the first exercise session, she commented on increased pain, underwent foot surgery recommended by her podiatrist, and decided not to continue in the study.
Trends were observed among the baseline, 13 week, and 26 week in the 3 groups. Of relevance is the decrease in functional score measured by the DASH in the gym exercise and home exercise groups, indicating less disability for the exercise groups. Increased function, as found in this study, has been reported in the literature as the effect of exercise interventions in cancer survivors.32 Another trend was observed in the 12-minute walk test, with an increase in the distance walked, as a measure of cardiorespiratory fitness in both exercise groups; this increase being significant in the home-exercise group.
Mutrie and colleague33 studied the effect of a 12-week exercise program for women with breast cancer on quality of life. They found no significant difference in quality of life after intervention; however, on 6-month follow up, quality of life showed a significant improvement. In this study, follow up was not measured; future trials should consider adding follow up measurements. Segal and colleagues10 found no significant difference in quality of life, measured by FACT-B, following participation in a 26-week long exercise program. The researchers speculated that the FACT-B measure may not be sensitive enough to the effects of exercise interventions. In this study, a slight nonsignificant increase in the quality of life score in the FACT-B was observed in the gym exercise group, as opposed to a decrease observed in the non-exercise and home exercise groups. One explanation for this increase could be that exercising in a setting such as a gym, where participants had the opportunity to go out of the house and meet people provided conditions for a better quality of life in the gym exercise group, not necessarily related to the exercise protocol itself.
Shoulder movement restriction has been identified as an impairment resulting after breast cancer operation.18,34 Activities such as sleeping, reaching out above the head level, and carrying objects have been found to be affected by such shoulder movement restriction. In this study, both the gym exercise and home exercise programs produced improvements in shoulder external rotation, abduction, and flexion. Such gains in range of motion might be the result of both exercise groups performing flexibility exercises as part of the warm-up and cool-down procedures in addition to the resistance exercises. Similar findings in range of motion were found by Cheema and Gaul35 during an 8-week regimen of resistance and aerobic training. It is expected that an increase in shoulder movement would allow an increased function in upper extremity, as indicated by the results of the DASH explained above. Beurskens and colleagues36 also reported increased flexion and abduction after a course of 9 physical therapy sessions after breast cancer surgery. Similar to this study, they also found no improvement in hand grip with intervention.
Body mass index was not changed as result of participation in this exercise program. Schmitz and colleagues37 found no changes in body weight or body mass index after a 26-week weight training program for breast cancer survivors. However, significant increases were reported in lean body mass, as well as significant decreases in body fat. In a meta-analysis of the effects of exercise on breast cancer patients and survivors, McNeely and colleagues38 found no clinically or statistically significant changes in body mass index as a result of exercise interventions included in their review. They suggest that examination of body composition (ie, changes in lean body mass, body fat, and bone density) might be a better outcome measure than body mass index.
Currently, no literature has been published reporting on the use of these outcome measurements with Puerto Rican female patients who are breast cancer survivors. These types of measurements proved to be useful and cost-effective and can be used in future studies. Similarly, minority women have been under-represented in physical activity studies.39 This study adds to the body of knowledge related to physical activity among minorities.
One of the major goals of this study was determining potential complications of participating in a gym-exercise program or a home exercise program. As lymphedema is a major complication following breast cancer surgery and treatment, development of lymphedema was monitored on the 3 evaluation sessions each participant had. The results of this study indicate that it is feasible to engage in moderate-intensity exercise without developing lymphedema.
This study identified concerns related to engagement in an exercise program faced by a sample of Hispanic women. For this purpose, anecdotal data was taken on situations that arouse during the course of the project.
Nutrition counseling was reported by staff members as a major need for this sample. Participants were repeatedly asking for advice to maintain or reduce weight through dieting. They were informed on the local clinics providing nutrition counseling, but no follow up was given to their attendance to such counseling. Their request made it clear that further research needs to incorporate nutrition counseling. Body mass index was not affected in this study. Since average BMI in all groups was above the recommended cut-off of 25.00,21 it would be wise to add this nutritional component to the exercise component in order to achieve a decrease in BMI.
Another major concern for participants was psychological services. As with nutrition counseling, women who asked for psychological services were provided with a list of professional resources in the community where they could call and make an appointment. Issues reported by participants were mainly related to body image; spouse relations such as concerns to ‘serve as women,’ and family relations such as expectations of family following breast cancer treatment. Similar findings on the experience of breast cancer and its impact as it relates to relationship and body image have been reported in the literature.40-42
Financial concerns were also an issue for the participants. Most have already used their sick days at work and attending to appointments during this project was difficult during working hours, as they needed to work to earn their living.
In Puerto Rico, interventions aimed to actively engage female patients who are breast cancer survivors in physical activity programs are not provided. Hispanics have been identified as having a higher prevalence of physical inactivity as compared to white non-Hispanics.43,44 The prevalence of inactivity is higher among women than men; higher among older adults than younger adults. In Puerto Rico, access to services such as physical therapy for female patients who are breast cancer survivors, wherein an individualized exercise program can be furnished, is limited to those who have a physician’s referral. This study has generated information that may lead to the development of effective exercise programs for breast cancer survivors in Puerto Rico.
If we consider that in Puerto Rico, the median household income is $14,412.00, with 44.6% of households falling below federal poverty level,45 an alternative for exercise at a gym, at low cost, needs to be examined, as the economic resources of women might limit their access to exercise facilities such as gyms. The home-exercise program studied here is an inexpensive alternative to gym participation for breast cancer survivors. However, income may still be a determinant of participation in an exercise program. Economic disadvantage could be related to inadequate access to specialized medical follow up in order to continue in the exercise program.
The sample size of breast cancer survivors who participated in this study was small. Recruitment and retention posed a difficulty in conducting this study. Future trials should encompass a larger geographical area and more aggressive promotion in an effort to increase recruitment. In our experience, recruitment needs have proved to be costly and therefore resources, both financial and human, need to be assigned for promotion of the study.
Another limitation of this study was participation. On average, participation in the gym exercise program, for the aerobic component was 47% and for the strengthening component was 63%. In the home exercise group, participation was higher: for the aerobic component 71% and for the strengthening component 86%. Although women reported to be pleased with attending the gym, it seems that adherence with the exercise program was easier when the exercises were performed at home or in their community.
For retention, it was our experience that this sample of survivors needed constant reminders for their appointment schedule. They tended to forget the day or time, and were irritated if they were not met on what they thought was the day and time of their appointment. Cognitive changes such as short-term memory loss after breast cancer treatment have been acknowledged.46 In this study, participants were given an appointment card where appointments were written for them and they were called the day before their appointment for a reminder. Due to misunderstandings in scheduling, one woman decided to discontinue her participation and another decided never to enroll in the study. Galantino and colleagues32 presented a review of the literature on the effects of exercise on cognition, concluding that aerobic exercise on healthy individuals improves cognition. However, there is no data on the effect of exercise on cognition in breast cancer survivors. In this study, cognition was not evaluated and future research trials should include evaluation of cognition as an outcome measure.
As stated above, not missing time from work to attend appointments was also very important for the participants. The staff had to work late in the afternoons or at lunch time to meet with the participants so that they would not miss working time.
We provided for a consultant oncologist when participants presented health complications, but funds were not available for consultation with other specialists or for paying procedures such as stress tests or MRIs, reasons why we lost 2 more participants.
In this study we found that it is feasible for breast cancer survivors living in Puerto Rico to participate in either a moderate-level gym-based or a moderate-level home-based exercise program. Researchers continue to question what level of exercise intensity is the best course of rehabilitation for survivors of breast cancer. We found that a moderate-level exercise program based either in the home or in a gym, did not result in the major medical complication of lymphedema and did result in several positive physiological benefits including increased range of motion of the upper extremity and increased whole body aerobic endurance. In addition, results showed a decrease in disability among subjects who participated in moderate level exercise as compared to those subjects who did not.
This study contributes not only to the general body literature on exercise and breast cancer but also to the relative paucity of exercise and breast cancer literature for minority populations. An important process outcome of this study is its use of accurately translated and culturally relevant valid and reliable functional measures.
Finally, the results, limitations, and future recommendations of the study offer outcome data and generated hypotheses for clinicians to continue to study the potential benefits and side effects of moderate level exercise for survivors of breast cancer.
Support for this study was provided by the National Institutes of Health (NIH NIGMS/MBRS SCORE S06 GM008224 support); the Clinical Research Center in Minority Institutions at the Medical Sciences Campus, University of Puerto Rico; the Cancer Center of Puerto Rico; and Theraband Academy. This publication was possible by grant number 5P20RR011126 from the National Center for Research Resources, a component of the National Institutes of Health. We appreciate the support of the staff of the Cancer Center of Puerto Rico, in particular Dr. Reynold López, Dr. Alberto Cardona, and their nurse, Carmen Cruz, University of Puerto Rico Cancer Center/MD Anderson Cancer Center: Partnership for Excellence in Cancer Research – U54 CA-096297. We appreciate the contributions of gathering data of Annie Font, MS, PT. We thank Mariely Nieves Plaza, MS, Biostatistics Core Manager; Laura Bretaña Figueroa, BA, Scientific Editor; Madeline Maldonado, BHE, MPH, CG, Patient Coordinator; Nilda L. González, M.S., M.T.(ASCP), Core Laboratory Manager; and nursing staff at the Clinical Research Center. Finally, we appreciate the assistance of Wilitza Martínez, MSPT, and Nilma Elías, MSPT, Research Specialists, at the Medical Sciences Campus, University of Puerto Rico.