Exercise in Peritoneal Dialysis Patients (PDEX)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peritoneal Dialysis, Kidney Failure, Chronic

Intervention / Treatment
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* Other: Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: Exercise Program<br>* Participants met with an exercise physiologist at their monthly center appointment over a 3-month period (4 meetings). The consultations took place either together or separate from or with the dietitian's consultation (depending on appointment logistics). In addition the Exercise Physiologists telephone called each intervention participant on a weekly basis.<br>|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Study - number of patients safely completing the study | The number of patients safely completing the study relative to the sampling frame | 1 month | 
| Adherence to exercise - total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed | the total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 second sit to stand test | Requires a participant to stand from a chair as many times as possible in 30 seconds | 3 months | 
| Pinch Strength Test | consists of three pinch tests: the tip pinch, lateral pinch and palmar pinch. All were performed following the American Society of Hand Therapists' recommendations | 3 months | 
| Timed Up and Go | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, physical function, patient reported outcomes