Home-based Exercise in Chronic Kidney Disease
- Conditions
- End-stage Renal DiseaseChronic Kidney Disease
- Interventions
- Other: Home-based exercise
- Registration Number
- NCT03621176
- Lead Sponsor
- Cardenal Herrera University
- Brief Summary
A home-based exercise program will be implemented in three different groups of participants: advanced chronic kidney disease, end-stage renal disease in substitutive treatment hemodialysis or peritoneal dialysis. Participants will be evaluated before the program, after 3 months and after 6 months from the starting of the program. During the first 3 months the researcher will phone them weekly to reinforce the exercise habit, and during the last three months, there will be no reinforcement. Assessment will include strength, functional capacity, health-related quality of life and depressive symptoms.
- Detailed Description
Three groups of participants (advanced chronic disease not yet in substitutive treatment, end-stage renal disease patients in hemodialysis and end-stage renal disease patients in peritoneal dialysis) will enter the study. The intervention will consist of a home-based exercise program. They will be provided with a booklet and the researcher will explain personally each of the exercises to the participants. Progression will be encouraged so that the participants should find the sessions 'somewhat hard' according to the rate of perceived exertion. Reinforcement will be high during the first 3 months (weekly phone calls, visits to the nephrology department) and none during the last 3 months. Assessment will be undertaken at three-time points: baseline, after 3 months of high reinforcement and after 3 more months of no reinforcement at all.
Assessment will include strength, functional capacity, health-related quality of life, cognitive state and depressive symptoms.
The aim of the study is to assess the effectiveness of home-based exercise to improve strength, physical function, health-related quality of life, cognitive state and depressive symptoms in advanced chronic kidney disease and end-stage renal disease (hemodialysis and peritoneal dialysis). We also aim at describing all these variables in the three different groups of patients. Adherence and satisfaction with the exercise program will be recorded at the end of the study.
Additionally, interobserver reliability will be calculated, so as reliability intraobserver in different measurement conditions (dialysis vs non-dialysis days).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- At least 3 months in hemodialysis treatment
- Clinically stable
- Recent cardiac events (less than 3 months)
- Unable to exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Home-based exercise Home-based exercise Home-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group
- Primary Outcome Measures
Name Time Method Change from baseline sit to stand 10 test at 12 and 24 weeks Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks Sit to stand to sit test 10, time to perform 10 repetitions
- Secondary Outcome Measures
Name Time Method Change from baseline STS-60 at 12 and 24 weeks Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks Sit to stand to sit test 60, number of repetitions performed during 60 seconds
Change from baseline SPPB at 12 and 24 weeks Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks Short physical performance battery, a combination of walking speed, STS-5 and balance
Change from baseline TUG at 12 and 24 weeks Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks Timed up and go test, time to stand up from a chair, walk 3m, turn around and sit back again
Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks Handgrip strength measured through a dynamometer
Change from baseline Six-minute walking test at 12 and 24 weeks Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks Distance covered in 6 minutes
Change from baseline OLHR at 12 and 24 weeks Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks One leg heel rise test, number of repetitions of heel rise to measure triceps strength
Change from baseline Health-related quality of life measured through the Euro quality of life questionnaire, 5 dimensions, at 12 and 24 weeks Baseline,12 weeks, 24 weeks Euroquol 5D questionnaire, scale 0 (worst health) to 100 (best health). 5 Dimensions include mobility, personal care, activities of daily living, pain, and anxiety/depression
Change from baseline Beck depression inventory at 12 and 24 weeks Baseline,12 weeks, 24 weeks Questionnaire to measure depressive symptoms. Range from 0 (normal) to 63 (worst depression)
Change from baseline OLST at 12 and 24 weeks Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks One-leg stand test, time to keep the balance in one leg
Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks Baseline,12 weeks, 24 weeks Questionnaire to measure physical activity. Higher scores represent higher activity.
Change from baseline Albumin at 12 and 24 weeks Baseline,12 weeks, 24 weeks Serum albumin in blood for dialysis patients
Change from baseline Human activity profile at 12 and 24 weeks Human activity profile Baseline,12 weeks, 24 weeks Questionnaire to measure physical activity. Higher score represents higher activity. Measures of average and maximal activity scores are reported. Average activity scores bellow 53 are considered impaired; between 53 and 74 are considered moderately active and above 74 are considered active.
Adherence 12 weeks, 24 weeks Sessions performed/offered x 100
Trial Locations
- Locations (1)
Hospital de Terrassa
🇪🇸Terrassa, Barcelona, Spain