Exercise in Patients With End Stage Kidney Disease

NCT03787589 | Recruiting DMC

• 1 other identifier: 618
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Failure

Keywords

Renal Failure; Hemodialysis; Peritoneal Dialysis; Exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Hand Grip Strength

  12 months

• Quality of Life using Vitality Subscale

  12 months

• Sleep Quality

  12 months

• Hospitalizations

  12 months

• Hospital Length of Stay

  12 months

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

Participants in this arm will receive standard of care along with the exercise prescription intervention

Behavioral: Exercise Prescription

Standard of Care

NO INTERVENTION

This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.

Interventions

Exercise Prescription BEHAVIORAL

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.

Exercise Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 1A2, Canada

RECRUITING

Related Publications (1)

• Suri RS, Moist L, Lok C, Clase CM, Harris J, Reid RD, Ramsay T, Zimmerman D. A Simple Exercise Program for Patients With End-Stage Kidney Disease to Improve Strength and Quality of Life: Clinical Research Protocol. Can J Kidney Health Dis. 2023 Oct 26;10:20543581231205160. doi: 10.1177/20543581231205160. eCollection 2023.

  PMID: 37901358 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Motor Activity

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Deborah Zimmerman, MD, MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Zimmerman, MD, MSc

CONTACT

613-738-8400; dzimmerman@toh.ca

Study Design

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

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: December 26, 2018
• Study Start: April 15, 2019
• Primary Completion: January 31, 2025
• Study Completion: September 15, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: One year after publication up to 3 years post publication
• Access Criteria: researchers with methodologically sound proposals approved by the principal investigator

Locations

CA (1)