Exercise in Peritoneal Dialysis Patients (PDEX)

Kidney Failure, Chronic Clinical Trial

— PDEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980795
• Other study ID #: SH107
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: May 2019
• Source: Satellite Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Peritoneal Dialysis
• Renal Insufficiency

Intervention

Other:
• Exercise Program
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.

Locations

Country	Name	City	State
United States	Satellite Wellbound Sacramento	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	30 second sit to stand test	Requires a participant to stand from a chair as many times as possible in 30 seconds	3 months
Secondary	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
Secondary	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