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A Multicenter Pilot Randomized Clinical Trial of a Home-Based Exercise Program for Patients With Cirrhosis: The Strength Training Intervention (STRIVE).
Lai, JC, Dodge, JL, Kappus, MR, Wong, R, Mohamad, Y, Segev, DL, McAdams-DeMarco, M
The American journal of gastroenterology. 2021;(4):717-722
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INTRODUCTION We developed the strength training intervention (STRIVE), a home-based exercise program targeting physical function in patients with cirrhosis. In this pilot study, we aimed to evaluate the safety and efficacy of STRIVE. METHODS Eligible were adult patients with cirrhosis at 3 sites. Patients were randomized 2:1-12 weeks of STRIVE, a 30-minute strength training video plus a health coach or standard of care (SOC). Physical function and quality of life were assessed using the Liver Frailty Index (LFI) and Chronic Liver Disease Questionnaire (CLDQ), respectively. RESULTS Fifty-eight and 25 were randomized to STRIVE and SOC arms, respectively: 43% women, median age was 61 years, MELDNa, Model for End-Stage Liver Disease Sodium was 14, and 54% were Child-Pugh B/C. Baseline characteristics were similar in the STRIVE vs SOC arms except for rates of hepatic encephalopathy (19 vs 36%). LFI @ 12 weeks was available in 43 STRIVE and 20 SOC participants. After 12 weeks, the median LFI improved from 3.8 to 3.6 (ΔLFI -0.1) in the STRIVE arm and 3.7 to 3.6 (ΔLFI -0.1) in the SOC arm (P = 0.65 for ΔLFI difference). CLDQ scores improved from 4.6 to 5.2 in STRIVE participants (ΔCLDQ 0.38) and did not change in SOC participants (4.2-4.2; ΔCLDQ -0.03) (P = 0.09 for ΔCLDQ difference). One patient died (SOC arm) of bleeding. Only 14% of STRIVE participants adhered to the strength training video for 10-12 weeks. No adverse events were reported by STRIVE participants. DISCUSSION STRIVE, a home-based structured exercise program for patients with cirrhosis, was safely administered at 3 sites, but adherence was low. Although all participants showed minimal improvement in the LFI, STRIVE was associated with a substantial improvement in quality of life.
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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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The impact on glycemic control through progressive resistance training with bioDensityTM in Chinese elderly patients with type 2 diabetes: The PReTTy2 (Progressive Resistance Training in Type 2 Diabetes) Trial.
Hangping, Z, Xiaona, Q, Qi, Z, Qingchun, L, Na, Y, Lijin, J, Siying, L, Shuo, Z, Xiaoming, Z, Xiaoxia, L, et al
Diabetes research and clinical practice. 2019;:64-71
Abstract
AIMS: To evaluate the effects of a novel, low-volume, high-intensity Progressive Resistance Training (PRT) technique on blood glucose control in elderly Chinese patients with Type 2 Diabetes. MATERIALS AND METHODS The PReTTy2 trial enrolled 300 male and female patients with Type 2 Diabetes in a randomized resistance training program with the bioDensity™ technique. 100 were control patients with no training intervention and 200 had resistance training. Anthropometry, biochemical parameters, HbA1c and fasting plasma glucose (FPG) were measured at baseline, 3-month and 6-month intervals. RESULTS 265 patients completed the study with no adverse events. There were no statistically significant differences in HbA1c for all patients, control and PRT groups, at baseline (p = 0.60), 3 months (p = 0.42) and 6-months (p = 0.45). Subgroup analysis with baseline HbA1c > 7.5% (58 mmol/mol), showed statistically significant differences in HbA1c and FPG between groups at 6 months (p < 0.05). All PRT group patients had statistically significant differences from baseline at 6 months for HDL (1.25 + 0.32 vs. 1.17 + 0.26 mmol/L, p < 0.001), LDL (3.23 ± 0.89 vs. 2.93 ± 0.80 mmol/L, p < 0.001) and total cholesterol (4.97 ± 1.22 vs. 4.58 ± 1.03 mmol/L, p < 0.001). CONCLUSIONS PRT improves glycemic indices in elderly patients with Type 2 Diabetes with poor glucose control as an adjunct to diet and medication. Progressive Resistance Training with bioDensity™ is feasible, safe and effective in elderly patients with Type 2 Diabetes.
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The association between six month intra-dialytic resistance training and muscle strength or physical performance in patients with maintenance hemodialysis: a multicenter retrospective observational study.
Moriyama, Y, Hara, M, Aratani, S, Ishikawa, H, Kono, K, Tamaki, M
BMC nephrology. 2019;(1):172
Abstract
BACKGROUND Reduced muscle strength and physical performance are prevalent in patients of maintenance hemodialysis (MHD), and deleterious changes in these parameters are associated with increased mortality. METHODS This retrospective observational study included 306 patients, who received a 6-month resistance exercise program during hemodialysis, three times per week on an outpatient basis. The training protocol consisted of two sets of 10 repetitions of knee extension, hip abduction, and hip flexion, using an elastic band in a sitting or supine position. Primary outcome measures included muscle strength, measured by percent knee extension muscle power to dry body weight (pKEMP-dBW), and physical performance, measured by short physical performance battery (SPPB). The adjusted mean differences in these variables during the 6 months were estimated using a multivariate linear regression model. RESULTS The mean age with standard deviation was 70 ± 11 years. One hundred and sixty patients (52.3%) were men and the dry weight was 55.6 ± 11.3 kg. Sarcopenia, defined as SPPB ≤8, was present in 21.4% patients. Their hemodialysis adequacy was acceptable, with a Kt/V of 1.65 ± 0.29, and their nutritional status was good, with a normalized protein catabolism rate of 0.89 ± 0.18 g/kg/day. During the 6 months, both pKEMP-dBW and SPPB showed a slight but significant increase with an adjusted mean difference of 2.8 (95% confidence interval 1.3-4.3, p < 0.001) and 0.6 (0.4-0.9, p < 0.001), respectively. CONCLUSIONS Six-month resistance training was associated with improved muscle strength and physical performance in patients with MHD.
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Two-year-supervised resistance training prevented diabetes incidence in people with prediabetes: A randomised control trial.
Dai, X, Zhai, L, Chen, Q, Miller, JD, Lu, L, Hsue, C, Liu, L, Yuan, X, Wei, W, Ma, X, et al
Diabetes/metabolism research and reviews. 2019;(5):e3143
Abstract
AIM: The purpose of this study is to explore the long-term effects of aerobic training (AT), resistance training (RT), and combined training (AT + RT) on the prevention of T2D incidence in patients with prediabetes. MATERIALS AND METHODS In this randomised controlled trial, people with prediabetes (fasting glucose ≥5.6 and <7.0 mmol/L and/or 2-h glucose ≥7.8 and <11.1 mmol/L on the 75-g oral glucose tolerance test and/or haemoglobin A1c ≥5.7% and <6.4%) were randomly assigned to the control group, AT group, RT group, or AT + RT group. Supervised exercise programmes, including AT, RT, and AT + RT, were completed for 60 minutes per day, three non-consecutive days per week for 24 months. The primary outcome was the incidence of T2D; secondary outcomes were blood glucose and lipid levels, including total cholesterol (TC) and standard 2-hour oral glucose tolerance (2hPG). RESULTS A total of 137 (80%) subjects with a mean age of 59 years (45 men, 92 women) entered the final analysis. After 24 months of intervention, the incidences of T2D adjusted by sex and age were significantly decreased by 74% (95% CI, 38-89), 65% (95% CI, 21-85), and 72% (95% CI, 36-87) in the AT + RT, RT, and AT groups compared with the control group (HR: AT + RT 0.26 [95% CI, 0.11-0.62], RT 0.35 [95% CI, 0.15-0.79], and AT 0.28 [95% CI, 0.13-0.64]). The cumulative T2D incidences were significantly lower in the AT + RT, RT, and AT groups than in the control group (21%, 26%, and 22% vs 69%). The blood glucose and lipid profiles improved more in the AT, RT, and AT + RT groups than in the control group. CONCLUSION RT and RT plus AT were as effective as isolated AT in preventing progression to T2D.
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Effect, process, and economic evaluation of a combined resistance exercise and diet intervention (ProMuscle in Practice) for community-dwelling older adults: design and methods of a randomised controlled trial.
van Dongen, EJI, Haveman-Nies, A, Wezenbeek, NLW, Dorhout, BG, Doets, EL, de Groot, LCPGM
BMC public health. 2018;(1):877
Abstract
BACKGROUND Exercise and nutrition are important for older adults to maintain or to regain their muscle mass, function, strength, and ultimately quality of life. The effectiveness of combined resistance exercise and diet interventions is commonly evaluated in controlled clinical studies, but evidence from real-life settings is lacking. This article describes the effectiveness, process, and economic evaluation design of a combined nutrition and exercise intervention for community-dwelling older adults in a Dutch real-life setting. METHODS The ProMuscle in Practice study is a randomised controlled multicentre intervention study, conducted in five municipalities in the Netherlands. Two hundred community-dwelling older adults (≥65 years) who are frail or pre-frail based on Fried frailty criteria or who experience strength loss are randomised over an intervention and control group by municipality. In the first 12-week intensive support intervention, participants in the intervention group perform resistance exercise training guided by a physiotherapist twice a week and increase protein intake by consuming protein-rich products under the supervision of a dietitian. Afterwards, they continue with a 12-week moderate support intervention. The control group receives only regular care during the two 12-week periods. Effect outcomes are measured at all locations at baseline, 12 weeks, 24 weeks, 36 weeks and only at three locations at 52 weeks. The primary outcome is physical functioning (Short Physical Performance Battery). Secondary outcomes include leg muscle strength, lean body mass, activities of daily living, social participation, food intake, and quality of life. Qualitative and quantitative implementation process data are collected during the intervention. Healthcare use and intervention costs are registered for the economic evaluation. DISCUSSION Evaluating the effects, implementation, and costs of this combined intervention provides valuable insight into the feasibility of this intervention for community-dwelling older adults and into the intervention's ability to improve or to maintain physical functioning and quality of life. TRIAL REGISTRATION Netherlands Trial Register ( NTR6038 ) since 30 August 2016.
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SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.
Montero-Odasso, M, Almeida, QJ, Burhan, AM, Camicioli, R, Doyon, J, Fraser, S, Li, K, Liu-Ambrose, T, Middleton, L, Muir-Hunter, S, et al
BMC geriatrics. 2018;(1):93
Abstract
BACKGROUND Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. METHODS The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. DISCUSSION The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. TRIAL REGISTRATION Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .
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Community Weight Loss to Combat Obesity and Disability in At-Risk Older Adults.
Rejeski, WJ, Ambrosius, WT, Burdette, JH, Walkup, MP, Marsh, AP
The journals of gerontology. Series A, Biological sciences and medical sciences. 2017;(11):1547-1553
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BACKGROUND Among older, overweight, and obese adults with either cardiovascular disease or the metabolic syndrome, reduced mobility and loss of leg strength are important risk factors for morbidity, disability, and mortality. It is unclear whether community-based approaches to weight loss may be an effective solution to this public health challenge. METHODS An 18-month three-site, randomized controlled trial conducted by YMCA staff, with blinded assessors, enrolled 249 older, overweight, and obese adults with either cardiovascular disease or metabolic syndrome with randomization to three interventions: weight loss alone (WL), weight loss + aerobic training (WL + AT), and weight loss + resistance training (WT + RT). The dual primary outcomes were 400-m walk time in seconds and knee extensor strength in Newton meters. RESULTS All groups lost weight from baseline: average baseline adjusted change of -6.1% (95% confidence interval [CI]: -7.5 to -4.7) for WL only, -8.6% (95% CI: -10.0 to -7.2) for WL + AT, and -9.7% (95% CI: -11.1 to -8.4) for WL + RT. Combined, the two physical activity + WL training groups had greater improvement in walk time than WL alone (mean difference 16.9 seconds [95% CI: 9.7 to 24.0], p < .0001). Baseline adjusted change in knee extensor strength was no greater with WL + RT than WL + AT (mean difference -3.6 Nm [95% CI: -7.5 to 0.3], p = .07). CONCLUSIONS At risk, older, overweight and obese adults can achieve clinically significant reductions in body weight with community-based weight loss programs. The change in percent weight loss and improvements in mobility are significantly enhanced when either RT or AT is combined with dietary WL.
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Nutritional Supplementation With Physical Activity Improves Muscle Composition in Mobility-Limited Older Adults, The VIVE2 Study: A Randomized, Double-Blind, Placebo-Controlled Trial.
Englund, DA, Kirn, DR, Koochek, A, Zhu, H, Travison, TG, Reid, KF, von Berens, Å, Melin, M, Cederholm, T, Gustafsson, T, et al
The journals of gerontology. Series A, Biological sciences and medical sciences. 2017;(1):95-101
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BACKGROUND Nutritional supplementation and physical activity have been shown to positively influence muscle mass and strength in older adults. The efficacy of long-term nutritional supplementation in combination with physical activity in older adults remains unclear. METHODS Mobility-limited (short physical performance battery [SPPB] ≤9) and vitamin D insufficient (serum 25(OH) D 9-24 ng/mL) older adults were recruited for this study. All subjects participated in a physical activity program. Subjects were randomized to consume a daily nutritional supplement (150 kcal, 20 g whey protein, 800 IU vitamin D, 119 mL beverage) or placebo (30 kcal, nonnutritive, 119 mL). In a prespecified secondary analysis, we examined total-body composition (dual energy X-ray absorptiometry), thigh composition (computed tomography), and muscle strength, power, and quality before and after the 6-month intervention. RESULTS One hundred and forty-nine subjects were randomized into the study [mean (standard deviation, SD) age 78.5 (5.4) years; 46.3% female; mean (SD) short physical performance battery 7.9 (1.2); mean (SD) vitamin D 18.7 (6.4) ng/mL]. After the intervention period both groups demonstrated improvements in muscle strength, body composition, and thigh composition. Nutritional supplementation lead to further losses of intermuscular fat (p = .049) and increased normal muscle density (p = .018). CONCLUSIONS Six months of physical activity resulted in improvements in body composition, subcutaneous fat, intermuscular fat, and strength measures. The addition of nutritional supplementation resulted in further declines in intermuscular fat and improved muscle density compared to placebo. These results suggest nutritional supplementation provides additional benefits to mobility-limited older adults undergoing exercise training. ClinicalTrials.gov Identifier: NCT01542892.
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Effects of an intradialytic resistance training programme on physical function: a prospective stepped-wedge randomized controlled trial.
Bennett, PN, Fraser, S, Barnard, R, Haines, T, Ockerby, C, Street, M, Wang, WC, Daly, R
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2016;(8):1302-9
Abstract
BACKGROUND Intradialytic exercise programmes are important because of the deterioration in physical function that occurs in people receiving haemodialysis. Unfortunately, exercise programmes are rarely sustained in haemodialysis clinics. The aim of this study was to determine the efficacy of a sustainable resistance exercise programme on the physical function of people receiving haemodialysis. METHODS A total of 171 participants from 15 community satellite haemodialysis clinics performed progressive resistance training using resistance elastic bands in a seated position during the first hour of haemodialysis treatment. We used a stepped-wedge design of three groups, each containing five randomly allocated cluster units allocated to an intervention of 12, 24 or 36 weeks. The primary outcome measure was objective physical function measured by the 30-s sit-to-stand (STS) test, the 8-foot timed up and go (TUG) test and the four-square step test. Secondary outcome measures included quality of life, involvement in community activity, blood pressure and self-reported falls. RESULTS Exercise training led to significant improvements in physical function as measured by STS and TUG. There was a significant average downward change (β = -1.59, P < 0.01) before the intervention and a significant upward change after the intervention (β = 0.38, P < 0.01) for the 30-s STS with a similar pattern noted for the TUG. CONCLUSION Intradialytic resistance training can improve the physical function of people receiving dialysis.