Exercise in Peritoneal Dialysis Patients (PDEX) (PDEX)
Primary Purpose
Peritoneal Dialysis, Kidney Failure, Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
About this trial
This is an interventional prevention trial for Peritoneal Dialysis focused on measuring exercise, physical function, patient reported outcomes
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
Sites / Locations
- Satellite Wellbound Sacramento
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Usual care
Outcomes
Primary Outcome Measures
Feasibility of Study - number of patients safely completing the study
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
the total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed
Secondary Outcome Measures
30 second sit to stand test
Requires a participant to stand from a chair as many times as possible in 30 seconds
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03980795
Brief Title
Exercise in Peritoneal Dialysis Patients (PDEX)
Acronym
PDEX
Official Title
Resistance and Cardiovascular Exercise for Peritoneal Dialysis Patients: a Randomized Pilot Study for a Parallel Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satellite Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis, Kidney Failure, Chronic
Keywords
exercise, physical function, patient reported outcomes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blinded Statistical Analysis
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Study - number of patients safely completing the study
Description
The number of patients safely completing the study relative to the sampling frame
Time Frame
1 month
Title
Adherence to exercise - total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed
Description
the total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed
Time Frame
3 months
Secondary Outcome Measure Information:
Title
30 second sit to stand test
Description
Requires a participant to stand from a chair as many times as possible in 30 seconds
Time Frame
3 months
Title
Pinch Strength Test
Description
consists of three pinch tests: the tip pinch, lateral pinch and palmar pinch. All were performed following the American Society of Hand Therapists' recommendations
Time Frame
3 months
Title
Timed Up and Go
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Schiller, MD
Organizational Affiliation
Satellite Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satellite Wellbound Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All feasibility data will be published
IPD Sharing Time Frame
De-identified data will be available. Results will disseminated through peer reviewed publication.
Citations:
PubMed Identifier
32734246
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.
Results Reference
derived
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Exercise in Peritoneal Dialysis Patients (PDEX)
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