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The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and 2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic parameters 4 months after finishing the exercise intervention (8 months after study initiation).
The investigators also aim to examine the impact of intradialytic pedaling exercise on general health, anthropometric measures, physical function, and routine laboratory blood markers as secondary outcome measures, as well as to assess feasibility, safety and adverse events associated with the intradialytic pedalling exercise.
Recruitment of more participants in the future will be considered if warranted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Participants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months. |
|
| Usual care | No Intervention | Participants receive their usual dialysis for the duration of 4 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in non-invasive measures of arterial stiffness using applanation tonometry. | 4 months and 8 months after study initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gait speed using a 6 meter walk course and timer. | 4 months and 8 months after study initiation | |
| Change in grip strength using a hand dynamometer. | 4 months and 8 months after study initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral and central blood pressure using a oscillometric cuff-based approach. | 4 months and 8 months after study initiation | |
| Change in total cholesterol levels | 4 months and 8 months after study initiation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stella S Daskalopoulou, MD, PhD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35018639 | Derived | Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653. | |
| 29126178 | Derived | Cooke AB, Ta V, Iqbal S, Gomez YH, Mavrakanas T, Barre P, Vasilevsky M, Rahme E, Daskalopoulou SS. The Impact of Intradialytic Pedaling Exercise on Arterial Stiffness: A Pilot Randomized Controlled Trial in a Hemodialysis Population. Am J Hypertens. 2018 Mar 10;31(4):458-466. doi: 10.1093/ajh/hpx191. |
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| Safety and adverse events. | 8 months |
| Change in triglyceride levels | 4 months and 8 months after study initiation |
| Change in high density lipoprotein cholesterol levels | 4 months and 8 months after study initiation |
| Change in low-density lipoprotein cholesterol levels | Calculated using the Friedewald equation based on total cholesterol and high density lipoprotein cholesterol levels | 4 months and 8 months after study initiation |
| Change in hemoglobin levels | 4 months and 8 months after study initiation |
| Change in leukocyte levels | 4 months and 8 months after study initiation |
| Change in platelet levels | 4 months and 8 months after study initiation |
| Change in albumin levels | 4 months and 8 months after study initiation |
| Change in serum electrolyte levels | 4 months and 8 months after study initiation |
| Change in phosphate levels | 4 months and 8 months after study initiation |
| Change in ferritin levels | 4 months and 8 months after study initiation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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