An interventional study of Exercise Prescription in Renal Failure, sponsored by Ottawa Hospital Research Institute. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
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Exclusion Criteria:
Participants in this arm will receive standard of care along with the exercise prescription intervention
Behavioral: Exercise Prescription
This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.
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.
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.
Time frame: 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.
Time frame: 12 months
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)
Time frame: 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)
Time frame: 12 months
Sleep Quality
Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
Time frame: 12 months
Hospitalizations
The number of hospitalizations per patient year
Time frame: 12 months
Hospital Length of Stay
Average number of days spent in hospital
Time frame: 12 months
Change in Living Status
Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
Time frame: 12 months
Safety of the Exercise Program
Safety will be measured by monitoring serious adverse events
Time frame: 12 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
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Ottawa Hospital Research Institute