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Clinical Trials/NCT03980795
NCT03980795CompletedNot Applicable

Resistance and Cardiovascular Exercise for Peritoneal Dialysis Patients: a Randomized Pilot Study for a Parallel Randomized Controlled Trial

Satellite Healthcare2 sites in 1 country36 target enrollmentStarted: October 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
2
Primary Endpoint
Feasibility of Study - number of patients safely completing the study

Study Overview

Brief Summary

Patients with end-stage kidney disease (ESKD) receiving peritoneal dialysis (PD) are physically inactive, resulting in poor physical function and reduced quality of life. The aim of this pilot trial was to test the study feasibility of a combined resistance and cardiovascular exercise program (recruitment and retention rates) and report adherence and adverse events. The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks. Control (C) group received normal care. Feasibility outcomes were exercise adherence rates and adverse events. Secondary measures included physical function measures and patient-reported outcome measures (PROMs)

Detailed Description

Patients with end-stage kidney disease (ESKD) receiving peritoneal dialysis (PD) are physically inactive, resulting in poor physical function and reduced quality of life. Combined resistance and cardiovascular exercise programs have been shown to be successful in hemodialysis patients but studies are limited in PD patients. The primary objectives of this pilot trial was to test the study feasibility of a combined resistance and cardiovascular exercise program (recruitment and retention rates) and report adherence and adverse events. Secondary objectives were to calculate the sample size for detecting differences in the 30 second sit to stand test (STS30) and measure the effect on physical function and patient reported outcome measures (PROMs).

Methods: The 3-month parallel two-arm pilot trial took place in California, USA. All participants were peritoneal dialysis patients in a single center who met inclusion criteria were invited into a randomized controlled trial. Recruitment was through face to face invitation following eligibility requirements. The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks. Control (C) group received normal care. Feasibility outcomes were exercise adherence rates and adverse events. Secondary physical function measures were change in I compared to the C group in STS30, pinch strength test (PST) and the 8 foot timed up and go test (8TUG). PROMs were measured using the London Evaluation of Illness (LEVIL) instrument. Data collection was not blinded but statistical analysis was blinded.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Blinded Statistical Analysis

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • end-stage kidney disease
  • receiving peritoneal dialysis for greater than 6 weeks
  • approved by the center Medical Director

Exclusion Criteria

  • unable to understand English
  • previous major amputations
  • unable to ambulate independently
  • known to be pregnant

Outcomes

Primary Outcomes

Feasibility of Study - number of patients safely completing the study

Time Frame: 1 month

The number of patients safely completing the study relative to the sampling frame

Adherence to exercise - total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed

Time Frame: 3 months

the total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed

Secondary Outcomes

  • 30 second sit to stand test(3 months)
  • Timed Up and Go(3 months)
  • Pinch Strength Test(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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