Exercise in Peritoneal Dialysis Patients (PDEX)

Not Applicable

Completed

• Conditions: Peritoneal Dialysis; Kidney Failure, Chronic
• Interventions: Other: Exercise Program

• Registration Number: NCT03980795
• Lead Sponsor: Satellite Healthcare

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 Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-06-07
• Last Update Submitted: 2019-06-09
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Exercise Program	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of Study - number of patients safely completing the study	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	3 months	the total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed

Secondary Outcome Measures

Name	Time	Method
30 second sit to stand test	3 months	Requires a participant to stand from a chair as many times as possible in 30 seconds
Timed Up and Go	3 months	the time in seconds it takes an adult to rise from sitting in a standard chair, walk 8 feet, turn, walk back to the chair and sit down using regular footwear
Pinch Strength Test	3 months	consists of three pinch tests: the tip pinch, lateral pinch and palmar pinch. All were performed following the American Society of Hand Therapists' recommendations

Trial Locations

Locations (1)

Satellite Wellbound Sacramento; 🇺🇸 Sacramento, California, United States