Exercise in Patients With End Stage Kidney Disease

NCT ID: NCT03787589

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2025-09-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise Intervention

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

Group Type: EXPERIMENTAL

Exercise Prescription

Intervention Type: 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.

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Zimmerman, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Deborah Zimmerman, MD, MSc

Role: CONTACT

dzimmerman@toh.ca

613-738-8400 ext. 82534

References

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.

Reference Type: DERIVED

PMID: 37901358 (View on PubMed)

Other Identifiers

618

Identifier Type: -

Identifier Source: org_study_id