Background

Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.

Methods

Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.

Results

A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.

Conclusions

In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.

Background

Exercise capacity as measured by VO2peak (peak oxygen uptake) is low in hemodialysis patients. The current study assesses the determinants of VO2peak in patients with chronic kidney failure who changed kidney replacement modality to either frequent hemodialysis or received a kidney transplant.

Study design

Cohort study with assessment at baseline and 6-months following modality change.

Setting & Participants

Participants included non-diabetic individuals receiving conventional hemodialysis who a) remained on conventional hemodialysis (n=13), b) changed to short daily hemodialysis (n=10), or c) received a transplant (n=5), and d) individuals who received pre-emptive transplant (n=15). Additionally, 34 healthy controls were assessed at baseline only.

Predictor

Modality change

Measurement & Outcomes

Exercise capacity, assessed from the physiologic components of the Fick equation (VO2 = cardiac output x a-vO2dif, where a-vO2dif is arterial to venous oxygen difference) was determined by measurement of VO2peak and cardiac output during symptom-limited exercise testing. Analysis of covariance was used to compare the differences in changes in VO2peak, cardiac output, heart rate, stroke volume, and a-vO2dif, at peak exercise between those who remained on hemodialysis and those who underwent transplant.

Results

Transplant was the only modality change that was associated with a significant change in VO2peak, occurring as a result of increased peak cardiac output and reflecting increased heart rate without change in peak a-vO2dif, despite increased hemoglobin levels. There were no differences in those who changed to daily hemodialysis compared to those who remained on conventional hemodialysis.

Limitations

Small, non-randomized study.

Conclusions

VO2peak increases significantly following kidney transplant but not with daily hemodialysis; this improvement reflects increased peak cardiac output via increased peak heart rate. Despite statistical significance, the increase in VO2peak was not clinically significant, suggesting the need for interventions such as exercise training to increase VO2peak in all patients, regardless of treatment modality.

Objectives

To determine whether objectively measured physical activity levels are associated with physical function and mobility in older men.

Design

Cross-sectional.

Setting

Academic research center.

Participants

Eighty-two community-dwelling men ≥ 65 years of age with self-reported mobility limitations were divided into a low activity and a high activity group based on the median average daily physical activity counts of the whole sample.

Measurements

Physical activity by triaxial accelerometers; physical function and mobility by the Short Physical Performance Battery (SPPB), gait speed, stair climb time, and a lift and lower task; aerobic capacity by maximum oxygen consumption (VO2max); and leg press and chest press maximal strength and peak power.

Results

Older men with higher compared to lower physical activity levels demonstrated a > 1.4 point higher mean SPPB score and a 0.35 m/s faster walking speed. They also climbed a standard flight of stairs 1.85 sec faster and completed 60% more shelves in a lift and lower task (all p < 0.01). Muscle strength and power measures, however, were not significantly different between the low and high activity group. Correlation analyses and multiple linear regression models showed that physical activity is positively associated with all physical function and mobility measures, leg press strength, and VO2max.

Conclusion

Older men with higher physical activity levels demonstrate better physical function and mobility than less active peers. Moreover, in older men physical activity levels are predictive of performance in measures of physical function and mobility. Future work is needed to determine whether modifications in physical activity levels can improve or preserve physical performance in later-life.

Background

Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment.

Objective

The purpose was to evaluate the effectiveness of a home-based exercise training intervention, the PRO-SELF FATIGUE CONTROL PROGRAM on the management of cancer related fatigue.

Interventions/Methods

Participants (N=119) were randomized into one of three groups: Group 1 (EE) received the exercise prescription throughout the study; Group 2 (CE) received their exercise prescription after completing cancer treatment; Group 3 (CC) received usual care. Patients completed the Piper Fatigue Scale, General Sleep Disturbance Scale, Center for Epidemiological Studies-Depression scale, and Worst Pain Intensity Scale.

Results

All groups reported mild fatigue levels, sleep disturbance and mild pain, but not depression. Using multilevel regression analysis significant linear and quadratic trends were found for change in fatigue and pain (i.e., scores increased, then decreased over time). No group differences were found in the changing scores over time. A significant quadratic effect for the trajectory of sleep disturbance was found, but no group differences were detected over time. No significant time or group effects were found for depression.

Conclusions

Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment. The optimal timing of exercise remains to be determined.

Implications for practice

Clinicians need to be aware that some physical activity is better than none, and there is no harm in exercise as tolerated during cancer treatment. Further analysis is needed to examine the adherence to exercise. More frequent assessments of fatigue, sleep disturbance, depression, and pain may capture the effect of exercise.

Nonalcoholic fatty liver disease (NAFLD) has been referred to as the hepatic manifestation of the metabolic syndrome. There is a lower prevalence of metabolic syndrome in individuals with higher health-related fitness (HRF) and physical activity (PA) participation. The relationship between NAFLD severity and HRF or PA is unknown. Our aim was to compare measures of HRF and PA in patients with a histological spectrum of NAFLD severity. Thirty-seven patients with liver biopsy–confirmed NAFLD (18 women/19 men; age = 45.9 ± 12.7 years) completed assessment of cardiorespiratory fitness (CRF, VO2peak), muscle strength (quadriceps peak torque), body composition (%fat), and PA (current and historical questionnaire). Liver histology was used to classify severity by steatosis (mild, moderate, severe), fibrosis stage (stage 1 versus stage 2/3), necroinflammatory activity (NAFLD Activity Score; ≤4 NAS1 versus ≥5 NAS2) and diagnosis of NASH by Brunt criteria (NASH versus NotNASH). Analysis of variance and independent t tests were used to determine the differences among groups. Fewer than 20% of patients met recommended guidelines for PA, and 97.3% were classified at increased risk of morbidity and mortality by %fat. No differences were detected in VO2peak (x = 26.8 ± 7.4 mL/g/min) or %fat (x = 38.6 ± 8.2%) among the steatosis or fibrosis groups. Peak VO2 was significantly higher in NAS1 versus NAS2 (30.4 ± 8.2 versus 24.4 ± 5.7 mL/kg/min, P = 0.013) and NotNASH versus NASH (34.0 ± 9.5 versus 25.1 ± 5.7 mL/kg/min, P = 0.048).

Conclusion

Patients with NAFLD of differing histological severity have suboptimal HRF. Lifestyle interventions to improve HRF and PA may be beneficial in reducing the associated risk factors and preventing progression of NAFLD.