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Clinical Trials/NCT03621176
NCT03621176
Completed
Not Applicable

Effects of Home-based Exercise in Advanced Chronic Kidney Disease and End-stage Renal Disease

Cardenal Herrera University1 site in 1 country57 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Cardenal Herrera University
Enrollment
57
Locations
1
Primary Endpoint
Change from baseline sit to stand 10 test at 12 and 24 weeks
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
February 14, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Cardenal Herrera University
Responsible Party
Principal Investigator
Principal Investigator

Eva Segura Ortí

Professor

Cardenal Herrera University

Eligibility Criteria

Inclusion Criteria

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion Criteria

  • Recent cardiac events (less than 3 months)
  • Unable to exercise

Outcomes

Primary Outcomes

Change from baseline sit to stand 10 test at 12 and 24 weeks

Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks

Sit to stand to sit test 10, time to perform 10 repetitions

Secondary Outcomes

  • Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
  • Change from baseline Six-minute walking test at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
  • Change from baseline OLHR at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
  • Change from baseline STS-60 at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
  • Change from baseline SPPB at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
  • Change from baseline TUG at 12 and 24 weeks(Baseline,1 week, non-dialysis day 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(Baseline,12 weeks, 24 weeks)
  • Change from baseline Beck depression inventory at 12 and 24 weeks(Baseline,12 weeks, 24 weeks)
  • Change from baseline OLST at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
  • Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks(Baseline,12 weeks, 24 weeks)
  • Change from baseline Albumin at 12 and 24 weeks(Baseline,12 weeks, 24 weeks)
  • Change from baseline Human activity profile at 12 and 24 weeks Human activity profile(Baseline,12 weeks, 24 weeks)
  • Adherence(12 weeks, 24 weeks)

Study Sites (1)

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