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1.  Perioperative rehabilitation in operation for lung cancer (PROLUCA) – rationale and design 
BMC Cancer  2014;14:404.
The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise.
Using a 2x2 factorial design with continuous effect endpoint (Maximal Oxygen Uptake (VO2peak)), 380 patients with non-small cell lung cancer (NSCLC) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups: (1) preoperative and early postoperative rehabilitation (starting two weeks after surgery); (2) preoperative and late postoperative rehabilitation (starting six weeks after surgery); (3) early postoperative rehabilitation alone; (4) today’s standard care which is postoperative rehabilitation initiated six weeks after surgery. The preoperative rehabilitation program consists of an individually designed, 30-minute home-based exercise program performed daily. The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling. The primary study endpoint is VO2peak and secondary endpoints include: Six-minute walk distance (6MWD), one-repetition-maximum (1RM), pulmonary function, patient-reported outcomes (PROs) on health-related quality of life (HRQoL), symptoms and side effects of the cancer disease and the treatment of the disease, anxiety, depression, wellbeing, lifestyle, hospitalization time, sick leave, work status, postoperative complications (up to 30 days after surgery) and survival. Endpoints will be assessed at baseline, the day before surgery, pre-intervention, post-intervention, six months after surgery and one year after surgery.
The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery.
Trial Registration
PMCID: PMC4053552  PMID: 24898680
Cancer; Rehabilitation; Exercise; Lung cancer; NSCLC
2.  The intra- and inter-rater reliability of five clinical muscle performance tests in patients with and without neck pain 
This study investigates the reliability of muscle performance tests using cost- and time-effective methods similar to those used in clinical practice. When conducting reliability studies, great effort goes into standardising test procedures to facilitate a stable outcome. Therefore, several test trials are often performed. However, when muscle performance tests are applied in the clinical setting, clinicians often only conduct a muscle performance test once as repeated testing may produce fatigue and pain, thus variation in test results. We aimed to investigate whether cervical muscle performance tests, which have shown promising psychometric properties, would remain reliable when examined under conditions similar to those of daily clinical practice.
The intra-rater (between-day) and inter-rater (within-day) reliability was assessed for five cervical muscle performance tests in patients with (n = 33) and without neck pain (n = 30). The five tests were joint position error, the cranio-cervical flexion test, the neck flexor muscle endurance test performed in supine and in a 45°-upright position and a new neck extensor test.
Intra-rater reliability ranged from moderate to almost perfect agreement for joint position error (ICC ≥ 0.48-0.82), the cranio-cervical flexion test (ICC ≥ 0.69), the neck flexor muscle endurance test performed in supine (ICC ≥ 0.68) and in a 45°-upright position (ICC ≥ 0.41) with the exception of a new test (neck extensor test), which ranged from slight to moderate agreement (ICC = 0.14-0.41). Likewise, inter-rater reliability ranged from moderate to almost perfect agreement for joint position error (ICC ≥ 0.51-0.75), the cranio-cervical flexion test (ICC ≥ 0.85), the neck flexor muscle endurance test performed in supine (ICC ≥ 0.70) and in a 45°-upright position (ICC ≥ 0.56). However, only slight to fair agreement was found for the neck extensor test (ICC = 0.19-0.25).
Intra- and inter-rater reliability ranged from moderate to almost perfect agreement with the exception of a new test (neck extensor test), which ranged from slight to moderate agreement. The significant variability observed suggests that tests like the neck extensor test and the neck flexor muscle endurance test performed in a 45°-upright position are too unstable to be used when evaluating neck muscle performance.
PMCID: PMC4219589  PMID: 24299621
Physical therapy; Cervical spine; Assessment tools; Joint position sense
3.  Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial 
Musculoskeletal disorders account for one third of the long-term absenteeism in Denmark and the number of individuals sick listed for more than four weeks is increasing. Compared to other diagnoses, patients with musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. It is a challenge to coordinate this type of intervention, and the implementation of a return-to-work (RTW)-coordinator is suggested as an effective strategy in this process. The purpose of this paper is to describe the study protocol and present a new type of intervention, where the physiotherapist both has the role as RTW-coordinator and treating the patient.
A randomized controlled trial (RCT) is currently on-going. The RCT includes 770 patients with low back pain of minimum four weeks who are referred to an outpatient back centre. The study population consists of patients, who are sick-listed or at risk of sick-leave due to LBP. The control group is treated with usual care in a team of a physiotherapist, a chiropractor, a rheumatologist and a social worker employed at the centre. The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist, a case manager from the municipal sickness benefit office, who has the authority in the actual case concerning sickness benefit payment and contact to the patients employer/work place. The treating physiotherapist is the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days off work. Secondary outcomes are disability, pain, and quality of life. The study will follow the recommendations in CONSORT-statement in designing and reporting RCTs.
This large RCT is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the municipal sickness benefit office participating in team meetings. The study has the potential to contribute to the knowledge about how to target the challenges in the treatment of LBP. The aim is to prevent sickness absence and labour market exclusion - both on the individual level and economic costs at community level. Short term results will be available in 2014.
This study is approved by the Danish Regional Ethics Committee ( H-C-2008-112) and is registered at.
Trial registration NCT01690234
PMCID: PMC3606127  PMID: 23496897
Low back pain (LBP); Return to work (RTW); Sickness absence; Rehabilitation; Prevention; Multidisciplinary intervention; Coordination; Denmark
4.  Effect of acute exercise on patella tendon protein synthesis and gene expression 
SpringerPlus  2013;2:109.
Evidence suggests that habitual loading can result in patellar tendon hypertrophy, especially at the proximal and distal parts of the patellar tendon. The underlying protein kinetic changes and its regulation remains controversial and human data, investigating this topic, are limited. The present study investigated how acute exercise affects growth factor production and collagen fractional synthetic rate in patellar tendon tissue from patients undergoing an anterior cruciate ligament reconstruction operation. The operation was performed by use of the bone-patellar tendon-bone method under spinal anesthesia.
Twelve subjects were randomized to one of two groups: a control group or an exercise group (1-hr unilateral knee-extension 67% of Wmax 24 hours before operation). Two hours before the anterior cruciate ligament operation a flooding-dose of L-[1-13C]proline was given. Tissue from the most proximal part of the patellar tendon was obtained during the operation. Tendon collagen fractional synthetic rate and mRNA concentrations of TGF-β-1, CTGF, and type I and III collagen were measured.
CTGF and type I collagen expression were higher in the exercise group compared to the control group (p < 0.05). Type III collagen expression (p = 0.11), TGF-β-1 expression (p = 0.34), and collagen fractional synthetic rate (p = 0.26) did not differ between groups.
Although the expression of CTGF and type I collagen were higher, the patellar tendon collagen fractional synthetic rate was not correspondingly higher after exercise. The elevated CTGF expression in the exercise group indicates that the TGF-beta pathway could be an important link between mechanical loading and stimulation of tendon tissue type I collagen expression.
PMCID: PMC3622742  PMID: 23586004
Tendon Collagen FSR; TGF-β-1; CTGF; Type I collagen; Type III collagen
In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research to quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means, risk differences, and other quantities that convey information. One of the goals in biomedical research is to develop parsimonious models ‐ meaning as simple as possible. This approach is valid if the subsequent research report (the article) is written independent of whether the results are “statistically significant” or not. In the present paper we outline the considerations and suggestions on how to build a trial protocol, with an emphasis on having a rigorous protocol stage, always leading to a full article manuscript, independent of statistical findings. We conclude that authors, who find (rigorous) protocol writing too troublesome, will realize that they have already written the first half of the final paper if they follow these recommendations; authors simply need to change the protocols future tense into past tense. Thus, the aim of this clinical commentary is to describe and explain the statistical principles for trial protocols in terms of design, analysis, and reporting of findings.
PMCID: PMC3474307  PMID: 23091782
analysis; research design; statistics
6.  Influence of Self-Efficacy on Compliance to Workplace Exercise 
Continuous neck and shoulder pain is a common musculoskeletal complaint. Physical exercise can reduce pain symptoms, but compliance to exercise is a challenge. Exercise-specific self-efficacy has been found to be a predictor of participation in preplanned exercise. Little is known about the influence of exercise-specific self-efficacy on compliance to workplace physical exercise.
To determine the influence of exercise-specific self-efficacy on compliance to specific strength exercises during working hours for laboratory technicians.
We performed a cluster-randomized controlled trial, including laboratory technicians from two industrial production units in Copenhagen, Denmark. The participants were randomized to supervised specific strength exercises for the neck and shoulder muscles for 20 minutes three times a week (n = 282) or to a reference group (n = 255). The participants answered baseline and follow-up questions regarding self-efficacy and registered all exercises in a diary.
Overall compliance to exercises was 45 %. Compliance in company A (private sector) differed significantly between the three self-efficacy groups after 20 weeks. The odds ratio of compliance was 2.37 for moderate versus low self-efficacy, and 2.93 for high versus low self-efficacy. No significant difference was found in company B (public sector) or in the intervention group as a whole.
We did not find self-efficacy to be a general statistically significant predictor of compliance to exercises during 20 weeks, but found self-efficacy to be a predictor of compliance in a private sector setting. Workplace-specific differences might be present and should be taken into account.
PMCID: PMC3767884  PMID: 22622819
Self-efficacy; Physical activity; Compliance
Achilles tendinopathy (AT) is a common pathology and the aetiology is unknown. For valid and reliable assessment The Victorian Institute of Sports Assessment has designed a self-administered Achilles questionnaire, the VISA-A. The aim of the present study was to evaluate VISA-A as an outcome measure in patients with AT.
A systematic search of the literature was conducted using MEDLINE, EMBASE, CINAHL, PEDro, Web of Science, and Cochrane Controlled trials to identify trials using VISA-A for patients with AT. This was followed by data mining and analysis of the obtained data.
Twenty-six clinical trials containing 1336 individuals were included. Overall mean VISA-A scores ranged from 24 (severe AT) to 100 (healthy). Mean VISA-A scores in patients with AT ranged from 24 to 96.6. Healthy subjects scored a minimum of 96. Only two groups of participants from two different studies had a post-VISA-A score as high as healthy individuals, indicating full recovery of the AT.
A VISA-A score lower than 24 is rarely attained in AT. Only few patients with AT reach an equivalent VISA-A score compared to uninjured healthy subjects following treatment. The VISA-A is a reliable tool when assessing AT patients, providing a good assessment of the actual condition from very poor, (score around 24) to excellent (a score of 90), which based on this systematic review and previous studies could be considered full recovery from AT.
PMCID: PMC3273883  PMID: 22319681
Achilles tendinopathy; outcome measure; reliability; VISA-A.
8.  Differential Glucose Uptake in Quadriceps and Other Leg Muscles During One-Legged Dynamic Submaximal Knee-Extension Exercise 
One-legged dynamic knee-extension exercise (DKE) is a widely used model to study the local cardiovascular and metabolic responses to exercise of the quadriceps muscles. In this study, we explored the extent to which different muscles of the quadriceps are activated during exercise using positron emission tomography (PET) determined uptake of [18F]-fluoro-deoxy-glucose (GU) during DKE. Five healthy male subjects performed DKE at 25 W for 35 min and both the contracting and contralateral resting leg were scanned with PET from mid-thigh and distally. On average, exercise GU was the highest in the vastus intermedius (VI) and lowest in the vastus lateralis (VL; VI vs VL, p < 0.05), whereas the coefficient of variation was highest in VL (VL vs VI, p < 0.05). Coefficient of variation between the mean values of the four quadriceps femoris (QF) muscles in the exercising leg was 35 ± 9%. Compared to mean GU in QF (=100%), GU was on average 73% in VL, 84% in rectus femoris, 115% in vastus medialis, and 142% in VI. Variable activation of hamstring muscles and muscles of the lower leg was also observed. These results show that GU of different muscles of quadriceps muscle group as well as between individuals vary greatly during DKE, and suggests that muscle activity is not equal between quadriceps muscles in this exercise model. Furthermore, posterior thigh muscles and lower leg muscles are more active than hitherto thought even during this moderate exercise intensity.
PMCID: PMC3200561  PMID: 22046164
glucose uptake; muscle activation; knee-extensors; EMG; PET
Lower limb injuries are a large problem in athletes. However, there is a paucity of knowledge on the relationship between alignment of the medial longitudinal arch (MLA) of the foot and development of such injuries. A reliable and valid test to quantify foot type is needed to be able to investigate the relationship between arch type and injury likelihood. Feiss Line is a valid clinical measure of the MLA. However, no study has investigated the reliability of the test.
The purpose was to describe a modified version of the Feiss Line test and to determine the intra- and inter-tester reliability of this new foot alignment test. To emphasize the purpose of the modified test, the authors have named it The Navicular Position Test.
Intra- and inter-tester reliability were evaluated of The Navicular Position Test with the use of ICC (interclass correlation coefficient) and Bland-Altman limits of agreement on 43 healthy, young, subjects.
Inter-tester mean difference -0.35 degrees [–1.32; 0.62] p = 0.47. Bland-Altman limits of agreement –6.55 to 5.85 degrees, ICC = 0.94. Intra-tester mean difference 0.47 degrees [–0.57; 1.50] p = 0.37. Bland-Altman limits of agreement –6.15 to 7.08 degrees, ICC = 0.91.
The present data support The Navicular Position Test as a reliable test of the navicular bone position during rest and loading measured in a simple test set-up.
The Navicular Position Test was shown to have a high intraday-, intra- and inter-tester reliability. When cut off values to categorize the MLA into planus, rectus, or cavus feet, has been determined and presented, the test could be used in prospective observational studies investigating the role of the arch type on the development of various lower limb injuries.
PMCID: PMC3163999  PMID: 21904698
Foot; Feiss Line; reliability; alignment; pronation
10.  Exercise increases interleukin-10 levels both intraarticularly and peri-synovially in patients with knee osteoarthritis: a randomized controlled trial 
Arthritis Research & Therapy  2010;12(4):R126.
The microdialysis method was applied to the human knee joint with osteoarthritis (OA) in order to reveal changes in biochemical markers of cartilage and inflammation, intraarticularly and in the synovium, in response to a single bout of mechanical joint loading.
Thirty-one female subjects with OA of the knee were randomized to non-exercise (NEx) or exercise (Ex) groups. Following acute resistance exercise (25 sets of 10 repetitions at 60% of 1 Repetition Maximum) or none (NEx), peripheral nerve blocks just below the inguinal ligament were applied and two microdialysis catheters were positioned in two different compartments, intraarticularly and peri-synovially. The microdialysis catheters were perfused at a slow rate (2 μl/minute) with a solution of Ringer-acetate and radioactively labelled glucose allowing for determination of relative recovery (RR) and calculation of interstitial concentrations of inflammatory and cartilage biomarkers over a three-hour period.
A significant increase of Interleukin (IL) -10 was discovered in both positions of the knee in the Ex group over the three hours post exercise, whereas IL-10 remained stationary over time in the NEx group. IL-6 and IL-8 displayed significant increases over time regardless of group and position of the catheter. Cartilage oligomeric matrix protein (COMP) decreased intraarticularly in the post exercise period in the Ex group compared to the NEx group.
Exercise caused an increase in both intraarticular and peri-synovial concentrations of IL-10 in a group of human females with knee OA. This suggests a positive effect of exercise on a chondroprotective anti-inflammatory cytokine response in patients with knee OA and might contribute to explaining the beneficial effect that exercise has on OA.
Trial registration
PMCID: PMC2945016  PMID: 20594330
11.  Determination of normal values for navicular drop during walking: a new model correcting for foot length and gender 
The navicular drop test is a measure to evaluate the function of the medial longitudinal arch, which is important for examination of patients with overuse injuries. Conflicting results have been found with regard to differences in navicular drop between healthy and injured participants. Normal values have not yet been established as foot length, age, gender, and Body Mass Index (BMI) may influence the navicular drop. The purpose of the study was to investigate the influence of foot length, age, gender, and BMI on the navicular drop during walking.
Navicular drop was measured with a novel technique (Video Sequence Analysis, VSA) using 2D video. Flat reflective markers were placed on the medial side of the calcaneus, the navicular tuberosity, and the head of the first metatarsal bone. The navicular drop was calculated as the perpendicular distance between the marker on the navicular tuberosity and the line between the markers on calcaneus and first metatarsal head. The distance between the floor and the line in standing position between the markers on calcaneus and first metatarsal were added afterwards.
280 randomly selected participants without any foot problems were analysed during treadmill walking (144 men, 136 women). Foot length had a significant influence on the navicular drop in both men (p < 0.001) and women (p = 0.015), whereas no significant effect was found of age (p = 0.27) or BMI (p = 0.88). Per 10 mm increase in foot length, the navicular drop increased by 0.40 mm for males and 0.31 mm for females. Linear models were created to calculate the navicular drop relative to foot length.
The study demonstrated that the dynamic navicular drop is influenced by foot length and gender. Lack of adjustment for these factors may explain, at least to some extent, the disagreement between previous studies on navicular drop. Future studies should account for differences in these parameters.
PMCID: PMC2685774  PMID: 19422696

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