Exercise in Patients With End Stage Kidney Disease
- Conditions
- Renal Failure
- Interventions
- Behavioral: Exercise Prescription
- Registration Number
- NCT03787589
- Lead Sponsor
- Ottawa Hospital Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Intervention Exercise Prescription Participants in this arm will receive standard of care along with the exercise prescription intervention
- Primary Outcome Measures
Name Time Method Adherence 12 months 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.
Recruitment Feasibility 30 months 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.
- Secondary Outcome Measures
Name Time Method Safety of the Exercise Program 12 months Safety will be measured by monitoring serious adverse events
Change in Living Status 12 months Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
Hand Grip Strength 12 months 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)
Quality of Life using Vitality Subscale 12 months Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)
Hospitalizations 12 months The number of hospitalizations per patient year
Sleep Quality 12 months Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
Hospital Length of Stay 12 months Average number of days spent in hospital
Trial Locations
- Locations (1)
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada