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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental | Participants in this arm will receive standard of care along with the exercise prescription intervention |
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| Standard of Care | No Intervention | This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Prescription | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Quality of Life using Vitality Subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Zimmerman, MD, MSc | Contact | 613-738-8400 | 82534 | dzimmerman@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Deborah Zimmerman, MD, MSc | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 1A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37901358 | Derived | 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. |
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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.
One year after publication up to 3 years post publication
researchers with methodologically sound proposals approved by the principal investigator
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy) |
| 12 months |
| Sleep Quality | Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep). | 12 months |
| Hospitalizations | The number of hospitalizations per patient year | 12 months |
| Hospital Length of Stay | Average number of days spent in hospital | 12 months |
| Change in Living Status | Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing | 12 months |
| Safety of the Exercise Program | Safety will be measured by monitoring serious adverse events | 12 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |