Clinical trial NCT03980795: Exercise in Peritoneal Dialysis Patients (PDEX)
Official title: Resistance and Cardiovascular Exercise for Peritoneal Dialysis Patients: a Randomized Pilot Study for a Parallel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis
Kidney Failure, Chronic
Keywords: exercise
physical function
patient reported outcomes
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Study - number of patients safely completing the study
timeFrame: 1 month
measure: Adherence to exercise - total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed
timeFrame: 3 months
Secondary outcomes:
measure: 30 second sit to stand test
timeFrame: 3 months
measure: Pinch Strength Test
timeFrame: 3 months
measure: Timed Up and Go
timeFrame: 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Satellite Wellbound Sacramento
state: California
Study officials:
affiliation: Satellite Healthcare
name: Brigitte Schiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennett PN, Hussein WF, Matthews K, West M, Smith E, Reiterman M, Alagadan G, Shragge B, Patel J, Schiller BM. An Exercise Program for Peritoneal Dialysis Patients in the United States: A Feasibility Study. Kidney Med. 2020 Mar 17;2(3):267-275. doi: 10.1016/j.xkme.2020.01.005. eCollection 2020 May-Jun.