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Randomized Controlled Trial of Exercise in CKD-The RENEXC Study.

ABSTRACT: Introduction:Home-based, clinically feasible trials in non-dialysis-dependent patients with chronic kidney disease (CKD) are sparse. We compared the effects of 2 different exercise training programs on physical performance, and measured glomerular filtration rate (mGFR) and albuminuria level in patients with CKD stages 3 to 5. Methods:This is a single-center, randomized controlled trial (RCT) comprising 151 patients (mGFR: 22 ± 8 ml/min per 1.73 m2; age 66 ± 14 years) randomized to either balance or strength training. Both groups were prescribed 30 minutes of exercise per day for 5 days per week for 12 months, comprising 60 minutes per week of endurance training and 90 minutes per week of either strength or balance exercises. The exercises were individually prescribed, and the intensity was monitored with Borg's rating of perceived exertion (RPE). Results:There were no treatment differences for any of the primary outcomes measuring physical performance. The strength and balance groups showed significantly increased effect sizes after 12 months for the following: walking (31 m and 24 m, P < 0.001) and the 30-second sit-to-stand test (both: 1 time, P < 0.001); quadriceps strength (right/left: strength 1.2/0.8 kg*m, P < 0.003; balance 0.6/0.9, P < 0.01); functional reach (both: 2 cm, P < 0.01); and fine motor skills (open/closed eyes, right/left, both: between 0.3 and 4 seconds faster, P < 0.05). After 12 months, there was a significant treatment difference for albuminuria (P < 0.02), which decreased by 33% in the strength group. In both groups, mGFR declined by 1.8 ml/min per 1.73 m2. Conclusion:Our primary hypothesis that strength training was superior to balance training was not confirmed. Within groups, 12 months of exercise training resulted in significant improvements in most measures of physical performance. Measured GFR declined similarly in the 2 groups. The strength group showed a significant decrease in albuminuria.

SUBMITTER: Hellberg M

PROVIDER: S-EPMC6609793 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Randomized Controlled Trial of Exercise in CKD-The RENEXC Study.

Hellberg Matthias M Höglund Peter P Svensson Philippa P Clyne Naomi N

Kidney international reports 20190409 7

<h4>Introduction</h4>Home-based, clinically feasible trials in non-dialysis-dependent patients with chronic kidney disease (CKD) are sparse. We compared the effects of 2 different exercise training programs on physical performance, and measured glomerular filtration rate (mGFR) and albuminuria level in patients with CKD stages 3 to 5.<h4>Methods</h4>This is a single-center, randomized controlled trial (RCT) comprising 151 patients (mGFR: 22 ± 8 ml/min per 1.73 m<sup>2</sup>; age 66 ± 14 years) r ...[more]

PMID: 31312771

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Project description:BackgroundThe present study was designed to determine the effect of short-term moderate-intensity exercise training on arterial stiffness in patients with chronic kidney disease (CKD) stage 3.Study designRandomized controlled trial with a parallel-group design.Setting & participantsTesting and training sessions were performed at Springfield College. 46 (treatment group, n=25; control group, n=21) patients with CKD with diabetes and/or hypertension completed the study.InterventionThe aerobic training program consisted of 16 weeks of supervised exercise training at 50%-60% peak oxygen uptake (Vo2peak) 3 times per week, while the control group remained sedentary. Identical testing procedures were performed following the 16-week intervention.OutcomesThe primary outcome was arterial stiffness. Secondary outcomes were aerobic capacity, various blood parameters (endothelin 1, nitrate/nitrite, and high-sensitivity C-reactive protein), and health-related quality of life.MeasurementsArterial stiffness was assessed with aortic pulse wave velocity (PWV), aerobic capacity by Vo2peak, blood parameters by enzyme-linked immunosorbent assays, and health-related quality of life by the 36-Item Short Form Health Survey (SF-36). Participants attended 4 sessions before being randomly assigned to either the treatment or control group. Participants gave consent during the first session, whereas a graded exercise test with measurement of Vo2peak was completed during the second session. During sessions 3 and 4, aortic PWV was measured at rest prior to 40 minutes of either moderate-intensity exercise training or seated rest. A venous blood sample was obtained prior to exercise or rest and participants completed the SF-36 questionnaire.Results16 weeks of training led to an 8.2% increase in Vo2peak for the treatment group (P=0.05), but no changes in aortic PWV .LimitationsRandomization was not concealed and was violated on one occasion; also, use of an indirect measurement of endothelial function and the short duration of the intervention.ConclusionsShort-term moderate-intensity exercise training does not alter arterial stiffness in patients with CKD, but seems to reduce endothelin 1 levels.

Project description:Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery.The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program.This randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies.Trial registration:Netherlands Trial Registry NTR5045 Date of trial registration: January 19th, 2015 Date and version study protocol: February 2017, version 1.

Project description:BackgroundArteriosclerosis is prevalent in patients with chronic kidney disease (CKD). Our aims were to investigate (1) the effects of 12 months of either balance- or strength- both in combination with endurance training on abdominal aortic calcification (AAC); on some lipids and calcific- and inflammatory markers; and (2) the relationships between the change in AAC score and these markers in non-dialysis dependent patients with CKD stages 3 to 5.MethodsOne hundred twelve patients (mean age 67 ± 13 years), who completed 12 months of exercise training; comprising either balance- or strength training, both in combination with endurance training; with a measured glomerular filtration rate (mGFR) 22.6 ± 8 mL/min/1.73m2, were included in this study. AAC was evaluated with lateral lumbar X-ray using the scoring system described by Kauppila. Plasma fetuin-A, fibroblast growth factor 23 (FGF23) and interleukin 6 (IL6) were measured with Enzyme-linked immunosorbent assay (ELISA) kits.ResultsAfter 12 months of exercise training, the AAC score increased significantly in both groups; mGFR and lipoprotein (a) decreased significantly in both groups; parathyroid hormone (PTH) and 1,25(OH)2D3 increased significantly only in the strength group; fetuin-A increased significantly only in the balance group. Plasma triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, FGF23, phosphate, calcium, IL6, C-reactive protein (CRP), albumin were unchanged. The increase in AAC score was positively related to ageing and the levels of baseline triglycerides and lipoprotein (a).ConclusionsExercise training did not prevent the progression of AAC; it might have contributed to the reduced levels of lipoprotein (a) and unchanged levels of calcific- and inflammatory markers in these patients with non-dialysis dependent CKD. Hypertriglyceridemia, high levels of lipoprotein (a) and ageing emerged as longitudinal predictors of vascular calcification in these patients.Trial registrationNCT02041156 at www.ClinicalTrials.gov. Date of registration: January 20, 2014. Retrospectively registered.

Project description:Rationale & objectiveWe aimed to test interventions to improve physical activity in persons with advanced chronic kidney disease not yet receiving dialysis.Study designRandomized controlled trial with parallel-group design.Setting & participantsWe embedded a pragmatic referral to exercise programming in high-volume kidney clinics servicing diverse populations in San Jose, CA, and Atlanta, GA. We recruited 56 participants with estimated glomerular filtration rates < 45 mL/min/1.73 m2.InterventionsWe randomly assigned participants to a mobile health (mHealth) group-wearable activity trackers and fitness professional counseling, or an Exercise is Medicine intervention framework (EIM) group-mHealth components plus twice-weekly small-group directed exercise sessions customized to persons with kidney disease. We performed assessments at baseline, 8 weeks at the end of active intervention, and 16 weeks after passive follow-up and used multilevel mixed models to assess between-group differences.OutcomesActivity tracker total daily step count.ResultsOf 56 participants, 86% belonged to a racial/ethnic minority group; randomly assigned groups were well balanced on baseline step count. In intention-to-treat analyses, the EIM and mHealth groups both experienced declines in daily step counts, but there was an attenuated reduction in light intensity physical activity (standard error 0.2 [5.8] vs -8.5 [5.4] min/d; P = 0.08) in the EIM compared with the mHealth group at 8 weeks. In as-treated analyses, total daily step count, distance covered, and light and moderate-vigorous activity minutes per day improved in the EIM group and declined in the mHealth group at 8 weeks (standard error +335 [506] vs -884 [340] steps per day; P = 0.05; P < 0.05 for secondary measures), but group differences faded at 16 weeks. There were no differences in quality-of-life and mental health measures during the study.LimitationsSmall sample size, limited duration of study, assessment of intermediate outcomes (steps per day).ConclusionsA clinic-integrated referral to small-group exercise sessions is feasible, safe, and moderately effective in improving physical activity in an underserved population with high comorbid conditions.FundingNormon S Coplon Applied Pragmatic Clinical Research program.Trial registrationNCT03311763.

Project description:BackgroundPeople with intellectual disabilities (ID) have low levels of physical activity (PA) together with accelerated aging profiles. Adherence to PA interventions for persons with ID is low based on barriers such as motivation. The IDEA study aims to determine the effect of two types of exercise programs, continuous aerobic (CAEP) vs sprint interval training (SIT), designed for seniors with ID on health-related physical fitness, cardiovascular parameters, quality of life (QoL), and emotional and cognitive function.MethodsIn this trial, ninety seniors with ID between the ages of 40 and 75 yrs. from occupational health centers from the Autonomous Region of Catalonia (Spain) will be recruited. Participants will be randomly allocated to the CAEP, SIT, and control group. Both intervention groups will train 3 days/week, 1.5 h/day over 6 months. Outcome variables will be assessed at baseline, 6 months and 12 months. The outcome variables include weight, height, body composition, cardiorespiratory fitness, muscle strength, balance, flexibility, cardiovascular parameters (blood pressure, pulse-wave velocity, pulse-wave analysis), QoL and cognitive function. The intervention effect will be determined with mixed models with repeated measures to assess changes in the outcome variables over time (baseline to month 12) and between study arms. Relationship between variables will be analyzed with appropriate regression analyses.DiscussionVarious studies reported on CAEP and SIT as exercise interventions for persons with ID with beneficial outcomes on body composition, fitness and blood pressure. To our knowledge, this is the first trial designed to analyse the positive changes on fitness, PA levels, cardiovascular, QoL and cognitive function promoted by CAEP training and SIT in seniors with ID. The findings of this study will assist in the development of more effective exercise interventions to ensure better compliance and adherence to exercise in seniors with ID.Trial registrationThe trial is registered at the ISRCTN registry. Registration number: ISRCTN43594228 . Registered 11 February 2019 - Retrospectively registered.

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Randomized Controlled Trial of Exercise in CKD-The RENEXC Study.

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Randomized Controlled Trial of Exercise in CKD-The RENEXC Study.

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