Exercise in Peritoneal Dialysis Patients (PDEX)

NCT03980795 | Completed

• 1 other identifier: SH107
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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)

Conditions

Peritoneal Dialysis; Kidney Failure, Chronic

Keywords

exercise; physical function; patient reported outcomes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 30 second sit to stand test

  3 months

• Pinch Strength Test

  3 months

• Timed Up and Go

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual care

Interventions

Exercise Program OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• end-stage kidney disease
• receiving peritoneal dialysis for greater than 6 weeks
• approved by the center Medical Director

You may not qualify if:

• unable to understand English
• previous major amputations
• unable to ambulate independently
• known to be pregnant

Sponsors & Collaborators

• Satellite Healthcare: lead

Study Sites (1)

Satellite Wellbound Sacramento

Sacramento, California, 95821, United States

Location

Related Publications (1)

• 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.

  PMID: 32734246 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brigitte Schiller, MD

  Satellite Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded Statistical Analysis
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 10, 2019
• Study Start: October 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: De-identified data will be available. Results will disseminated through peer reviewed publication.

Locations

US (1)