Exercise in Patients With End Stage Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03787589|
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : July 23, 2019
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, regular use of a pedometer to monitor progress, and for participants with Wi-Fi access, participation in a physical activity social network with other patients. Both groups will receive 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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure||Behavioral: Exercise Prescription||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Exercise Intervention
Participants in this arm will receive standard of care along with the exercise prescription intervention
Behavioral: 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, monitor adherence and allow them to join a virtual exercise group that will include dialysis patients with similar levels of baseline activity.
No Intervention: Standard of Care
This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.
- Recruitment Feasibility [ Time Frame: 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.
- Adherence [ Time Frame: 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.
- Hand Grip Strength [ Time Frame: 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 [ Time Frame: 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)
- Sleep Quality [ Time Frame: 12 months ]Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
- Hospitalizations [ Time Frame: 12 months ]The number of hospitalizations per patient year
- Hospital Length of Stay [ Time Frame: 12 months ]Average number of days spent in hospital
- Change in Living Status [ Time Frame: 12 months ]Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
- Safety of the Exercise Program [ Time Frame: 12 months ]Safety will be measured by monitoring serious adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787589
|Contact: Deborah Zimmerman, MD, MSc||613-738-8400 ext firstname.lastname@example.org|
|Ottawa, Ontario, Canada, K1H 1A2|
|Principal Investigator: Deborah Zimmerman, MD, MSc|