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A multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemic.
Binder, EF, Christensen, JC, Stevens-Lapsley, J, Bartley, J, Berry, SD, Dobs, AS, Fortinsky, RH, Hildreth, KL, Kiel, DP, Kuchel, GA, et al
Contemporary clinical trials. 2021;:106356
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BACKGROUND Up to 75% of hip fracture patients never recover to their pre-fracture functional status. Supervised exercise that includes strength training can improve functional recovery after hip fracture. The role of testosterone replacement for augmenting the effects of exercise in older women after hip fracture is unknown. METHODS The Starting Testosterone and Exercise after Hip Injury (STEP-HI) Study is a 6-month Phase 3 multicenter randomized placebo-controlled trial designed to compare supervised exercise (EX) plus 1% testosterone topical gel, with EX plus placebo gel, and with enhanced usual care (EUC). Female hip fracture patients age ≥ 65 years are being recruited from clinical centers across the United States. Participants are community dwelling and enrolled within 24 weeks after surgical repair of the fracture. The EX intervention is a center-based program of progressive resistance training. The EUC group receives a home exercise program and health education. Participants receive dietary counseling, calcium and vitamin D. The primary outcome is the Six Minute Walk Distance. Secondary outcomes include physical performance measures, self-reported function and quality of life, and dual energy x-ray absorptiometry measures of body composition and bone mineral density. RESULTS Enrollment, interventions, and follow-up are ongoing. We describe the impact of the coronavirus disease 2019 pandemic on the trial, including modifications made to allow continuation of the interventions and outcome data collection using remote video and audio technology. CONCLUSIONS Results from the STEP-HI study are expected to have important clinical and public health implications for management of the growing population of hip fracture patients.
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Simple resistance exercise decreases cytokeratin 18 and fibroblast growth factor 21 levels in patients with nonalcoholic fatty liver disease: A retrospective clinical study.
Takahashi, A, Abe, K, Fujita, M, Hayashi, M, Okai, K, Ohira, H
Medicine. 2020;(22):e20399
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Cytokeratin 18 (CK18) and fibroblast growth factor 21 (FGF21) are elevated in patients with nonalcoholic fatty liver disease (NAFLD) and are useful markers for identifying or monitoring outcomes. Exercise therapy is one of the established treatments for NAFLD; however, few studies have investigated the effectiveness of exercise therapy on CK18 and FGF21 levels. Therefore, the aim of the present study was to assess the effects of 12 weeks of simple resistance exercise on CK18 and FGF21 levels in patients with NAFLD.Fifty patients with NAFLD were assigned to a resistance exercise group (n = 23) or a control group (n = 27) for a trial period of 12 weeks. During the study, the resistance exercise group performed two exercises (push-ups and squats) three times a week on nonconsecutive days, whereas the control group proceeded with regular physical activities under a restricted diet. We then compared serum levels of CK18 fragments (M65) and FGF21 between groups just before and after the 12-week period.Serum M65 levels (880.0 ± 503.6 vs 648.9 ± 450.2 U/L; P < .01) were significantly decreased in the exercise group. However, no significant differences were observed in body mass index or skeletal muscle. The decreases in serum M65 (-231.1 ± 354.7 vs 56.2 ± 375.0 U/L; P = .02), and FGF21 levels (-41.7 ± 98.2 vs. 33.2 ± 127.6 pg/mL; P = .03) were significantly greater in the exercise than in the control group. Changes in M65 levels in the exercise group were significantly correlated with changes in alanine aminotransferase levels (r = 0.618, P < .01).Simple resistance exercise reduced CK18 and FGF21 levels in patients with NAFLD. These findings suggest that resistance exercise consisting of push-ups and squats helps prevent the progression of NAFLD.
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Isolated Lumbar Extension Resistance Training Improves Strength, Pain, and Disability, but Not Spinal Height or Shrinkage ("Creep") in Participants with Chronic Low Back Pain.
Steele, J, Bruce-Low, S, Smith, D, Jessop, D, Osborne, N
Cartilage. 2020;(2):160-168
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Objective. Loss of disc height is commonly associated with chronic low back pain (CLBP). Isolated lumbar extension (ILEX) exercise for the lumbar extensors is recommended to treat CLBP and is suggested such exercise might promote disc healing and regeneration. This study examined a 12-week ILEX intervention on indirect determination of disc height and shrinkage through seated stadiometry, strength, pain, and disability. Design. A quasi-experimental wait-list controlled design was used. Nine participants underwent pretesting (T1), a 12-week control period, retesting (T2), a 12-week intervention period, and finally posttesting (T3). Seated stadiometry, ILEX strength, pain, and disability were measured at each time point. Results. No significant repeated-measures effects for any seated stadiometry variables occurred. Significant improvement across the intervention period (T2 to T3) was found for strength (P <0.0001; effect size [ES] = 2.42). Change in pain was not significant for repeated effects (P = 0.064); however, ES for the intervention period (T2 to T3) was moderate (ES = -0.77). Change in disability was significant between time point T1 and T3 (P = 0.037) and ES for the intervention period (T2 to T3) was large (ES = -0.92). Pain and disability achieved minimal clinically important changes. Conclusions. This is apparently the first study to examine disc change in vivo after exercise in CLBP. Results of the present study, though supporting ILEX resistance training to improve strength, pain, and disability, did not find any effect on spinal height.
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Effects of elastic band resistance training and nutritional supplementation on muscle quality and circulating muscle growth and degradation factors of institutionalized elderly women: the Vienna Active Ageing Study (VAAS).
Hofmann, M, Schober-Halper, B, Oesen, S, Franzke, B, Tschan, H, Bachl, N, Strasser, EM, Quittan, M, Wagner, KH, Wessner, B
European journal of applied physiology. 2016;(5):885-97
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PURPOSE Regular resistance exercise training and a balanced diet may counteract the age-related muscular decline on a molecular level. The aim of this study was to investigate the influence of elastic band resistance training and nutritional supplementation on circulating muscle growth and degradation factors, physical performance and muscle quality (MQ) of institutionalized elderly. METHODS Within the Vienna Active Ageing Study, 91 women aged 83.6 (65.0-92.2) years were randomly assigned to one of the three intervention groups (RT, resistance training; RTS, resistance training plus nutritional supplementation; CT, cognitive training). Circulating levels of myostatin, activin A, follistatin, IGF-1 and GDF-15, as well as MQ and functional parameters were tested at baseline as well as after 3 and 6 months of intervention. RESULTS MQ of lower extremities significantly increased in the RT group (+14 %) and RTS group (+12 %) after 6 months. Performance improved in the RT and RTS groups for chair stand test (RT: +18 %; RTS: +15 %). Follistatin increased only in the RT group (+18 %) in the latter phase of the intervention, accompanied by a decrease in the activin A-to-follistatin ratio (-7 %). IGF-1, myostatin and GDF-15 levels were not affected by the intervention. CONCLUSION Our data confirm that strength training improves physical performance and MQ even in very old institutionalized women. This amelioration appears to be mediated by blocking muscle degradation pathways via follistatin rather than inducing muscle growth through the IGF-1 pathway. As plasma levels of biomarkers reflect an overall status of various organ systems, future studies of tissue levels are suggested.
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Should we treat obesity in COPD? The effects of diet and resistance exercise training.
McDonald, VM, Gibson, PG, Scott, HA, Baines, PJ, Hensley, MJ, Pretto, JJ, Wood, LG
Respirology (Carlton, Vic.). 2016;(5):875-82
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BACKGROUND AND OBJECTIVE Obesity is an established risk factor for poor health outcomes, but paradoxically in chronic obstructive pulmonary disease (COPD), it is associated with improved survival and lung function. A major evidence gap exisits to inform treatment recommendations for patients with COPD who are obese. We aimed to determine the effect of weight reduction involving a low-energy diet utilizing a partial meal replacement plan, coupled with resistance exercise training in obese COPD patients. METHODS In a proof of concept before-after clinical trial, obese (body mass index ≥30 kg/m(2) ) COPD patients received a 12 week weight reduction programme involving meal replacements, dietary counselling by a dietitian and resistance exercise training prescribed and supervised by a physiotherapist. Patients were reviewed face to face by the dietitian and physiotherapist every 2 weeks for counselling. RESULTS Twenty-eight participants completed the intervention. Mean (standard deviation) body mass index was 36.3 kg/m(2) (4.6) at baseline and reduced by 2.4 kg/m(2) ((1.1) P < 0.0001) after the intervention. Importantly, skeletal muscle mass was maintained. Clinical outcomes improved with weight loss including exercise capacity, health status, dyspnea, strength and functional outcomes. There was also a significant reduction in the body mass index, obstruction, dyspnea and exercise score (BODE). Systemic inflammation measured by C-reactive protein however did not change. CONCLUSION In obese COPD patients, dietary energy restriction coupled with resistance exercise training results in clinically significant improvements in body mass index, exercise tolerance and health status, whilst preserving skeletal muscle mass. This novel study provides a framework for development of guidelines for the management of obese COPD patients and in guiding future research.
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Resistance training improves isokinetic strength and metabolic syndrome-related phenotypes in postmenopausal women.
Oliveira, PF, Gadelha, AB, Gauche, R, Paiva, FM, Bottaro, M, Vianna, LC, Lima, RM
Clinical interventions in aging. 2015;:1299-304
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PURPOSE To examine the effects of resistance training (RT) on metabolic syndrome-related phenotypes in postmenopausal women. PATIENTS AND METHODS Twenty-two postmenopausal women (65.0±4.2 years) underwent 12 weeks of whole body progressive training with intensity prescribed based on rating of perceived exertion. Dominant knee extension strength was assessed using an isokinetic dynamometer before and after the intervention. Moreover, all volunteers had blood samples collected for lipid profile, glycemic control, and C-reactive protein analyses. Waist circumference and arterial blood pressure were also measured at baseline and after the training period. Student's t-tests for paired samples and repeated measures ANOVA were used to compare dependent variables, and statistical significance was set at P<0.05. RESULTS Isokinetic muscle strength significantly increased (P<0.01) with training. It was observed that waist circumference as well as total and low-density lipoprotein cholesterol levels significantly decreased with training (P<0.01). Total cholesterol/high-density lipoprotein cholesterol ratio, an important marker of cardiovascular disease incidence, was also significantly reduced (from 3.91±0.91 to 3.60±0.74; P<0.01) after the program. Blood glucose, basal insulin, and homeostatic model assessment of insulin resistance were also significantly reduced (P<0.01). No significant alterations were observed for resting blood pressure, triglycerides, or C-reactive protein. CONCLUSION Based on the observed results, it can be concluded that a 12-week progressive RT program, besides increasing isokinetic muscle strength, induces beneficial alterations on metabolic syndrome-related phenotypes in postmenopausal women. These findings highlight this mode of exercise as an important component of public health promotion programs for aged women. RT improves isokinetic strength and metabolic syndrome-related phenotypes in postmenopausal women.
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Effects of a combined aerobic and resistance exercise program on C1q/TNF-related protein-3 (CTRP-3) and CTRP-5 levels.
Choi, HY, Park, JW, Lee, N, Hwang, SY, Cho, GJ, Hong, HC, Yoo, HJ, Hwang, TG, Kim, SM, Baik, SH, et al
Diabetes care. 2013;(10):3321-7
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OBJECTIVE To examine the effect of a combined exercise program on C1q/tumor necrosis factor-related protein (CTRP) 3 and CTRP-5 levels and novel adiponectin paralogs suggested to be links between metabolism and inflammation and to evaluate sex differences and association with cardiometabolic risk factors in humans with use of a newly developed ELISA. RESEARCH DESIGN AND METHODS This cross-sectional study explored the implications of CTRP-3 and CTRP-5 on cardiometabolic parameters in 453 nondiabetic Korean adults. In addition, we evaluated the impact of a 3-month combined exercise program on CTRP-3 and CTRP-5 levels in 76 obese women. The exercise program consisted of 45 min of aerobic exercise at an intensity of 60-75% of the age-predicted maximum heart rate (300 kcal/session) and 20 min of resistance training (100 kcal/session) five times per week. RESULTS Both CTRP-3 and CTRP-5 concentrations were significantly higher in women (P<0.001) than in men (P=0.030). In a multiple stepwise regression analysis, CTRP-3 levels were independently associated with age, sex, and triglyceride, LDL cholesterol, adiponectin, and retinol-binding protein 4 (RBP4) levels (R2=0.182). After 3 months of a combined exercise program, cardiometabolic risk factors, including components of metabolic syndrome, insulin resistance, and RBP4 levels, decreased significantly. In particular, CTRP-3 levels decreased significantly (median [interquartile range] 444.3 [373.8-535.0] to 374.4 [297.2-435.9], P<0.001), whereas CTRP-5 levels were slightly increased (34.1 [28.6-44.3] to 38.4 [29.8-55.1], P=0.048). CONCLUSIONS A 3-month combined exercise program significantly decreased CTRP-3 levels and modestly increased CTRP-5 levels in obese Korean women.