Exercise in Patients With End Stage Kidney Disease

A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study

This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes.

The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.

Study Overview

• Status: Recruiting
• Conditions: Renal Failure
• Intervention / Treatment: Behavioral: Exercise Prescription

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah Zimmerman, MD, MSc; Phone Number: 82534 613-738-8400; Email: dzimmerman@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 1A2
      • Recruiting
      • Ottawa Hospital
      • Principal Investigator: Deborah Zimmerman, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. All ambulatory adult patients with end stage kidney disease
2. Treatment with peritoneal dialysis or hemodialysis for greater than six months
3. Able to understand English or French
4. Abuse to use Nordic Walking poles
5. Able and willing to provide informed consent

Exclusion Criteria:

1. Any absolute contraindication to exercise [unstable angina, uncontrolled hypertension (systolic or diastolic blood pressure greater than 180 mmHg (millimeters of mercury) or greater than 110 mmHg, respectively), deemed not suitable for exercise by the treating physician]
2. Baseline step count greater than 8000 steps a day
3. Planned living donor kidney transplant
4. Potential for recovery of renal function
5. Patients who feel unsafe using Nordic walking poles in place of their mobility aid
6. Participation in another interventional trial that may affect the results of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention; Participants in this arm will receive standard of care along with the exercise prescription intervention	Behavioral: Exercise Prescription; Participants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps. All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence.
No Intervention: Standard of Care; This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility	The investigators will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.	30 months
Adherence	Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Grip Strength	The investigators will measure hand grip strength at baseline, 6, and 12 months using a handgrip dynamometer in the dominant hand or in the non-arteriovenous fistula arm (best of two efforts in kgs)	12 months
Quality of Life using Vitality Subscale	Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)	12 months
Sleep Quality	Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).	12 months
Hospitalizations	The number of hospitalizations per patient year	12 months
Hospital Length of Stay	Average number of days spent in hospital	12 months
Change in Living Status	Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing	12 months
Safety of the Exercise Program	Safety will be measured by monitoring serious adverse events	12 months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Deborah Zimmerman, MD, MSc, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Hemodialysis; Renal Failure; Peritoneal Dialysis
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, manual of operations and consent form will be made available by contacting the corresponding author. De-identified patient data will be available from 12 months to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
• IPD Sharing Time Frame: One year after publication up to 3 years post publication
• IPD Sharing Access Criteria: researchers with methodologically sound proposals approved by the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No