Recruiting

Exercise

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03787589

Conditions

Renal Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Prescription

Study Details

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 ID

NCT03787589

Start date

Apr 15, 2019

Status verified date

Jun, 2024

Completion date

Sep 15, 2025

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Intervention

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

no intervention: Standard of Care

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

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.

Primary outcome measure

  • Recruitment Feasibility [ Time Frame: 30 months ]
  • Adherence [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Deborah Zimmerman, MD, MSc

613-738-8400dzimmerman@toh.ca

Locations

Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 1A2

Principal Investigator:

Deborah Zimmerman, MD, MSc

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jun 26, 2024

Last verified

Jun, 2024

Keywords

  • Renal Failure
  • Hemodialysis
  • Peritoneal Dialysis
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-06-26.