An interventional study of Home-based exercise in Chronic Kidney Disease and End-stage Renal Disease, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment
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.
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).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 57 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
Home-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group
Other: Home-based exercise
A booklet with detailed information will be provided, and the exercises will be previously reviewed with every patient by the researcher. Participants will be encouraged to perform at least 3 sessions per week and monitor their heart rate. They will be instructed that the exercises should be perceived as 'somewhat hard' from a rate of perceived exertion. Adaptations to increase the intensity of the exercises will be provided so that participants can progress in exercise intensity
Change from baseline sit to stand 10 test at 12 and 24 weeks
Sit to stand to sit test 10, time to perform 10 repetitions
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline Six-minute walking test at 12 and 24 weeks
Distance covered in 6 minutes
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline STS-60 at 12 and 24 weeks
Sit to stand to sit test 60, number of repetitions performed during 60 seconds
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline OLHR at 12 and 24 weeks
One leg heel rise test, number of repetitions of heel rise to measure triceps strength
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks
Handgrip strength measured through a dynamometer
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline SPPB at 12 and 24 weeks
Short physical performance battery, a combination of walking speed, STS-5 and balance
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline OLST at 12 and 24 weeks
One-leg stand test, time to keep the balance in one leg
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline TUG at 12 and 24 weeks
Timed up and go test, time to stand up from a chair, walk 3m, turn around and sit back again
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline Albumin at 12 and 24 weeks
Serum albumin in blood for dialysis patients
Time frame: Baseline,12 weeks, 24 weeks
Change from baseline Health-related quality of life measured through the Euro quality of life questionnaire, 5 dimensions, at 12 and 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
Time frame: Baseline,12 weeks, 24 weeks
Change from baseline Beck depression inventory at 12 and 24 weeks
Questionnaire to measure depressive symptoms. Range from 0 (normal) to 63 (worst depression)
Time frame: Baseline,12 weeks, 24 weeks
Change from baseline Human activity profile at 12 and 24 weeks Human activity profile
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.
Time frame: Baseline,12 weeks, 24 weeks
Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks
Questionnaire to measure physical activity. Higher scores represent higher activity.
Time frame: Baseline,12 weeks, 24 weeks
Adherence
Sessions performed/offered x 100
Time frame: 12 weeks, 24 weeks
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Cardenal Herrera University