Chronic Kidney Disease Requiring Chronic Dialysis
Conditions
Keywords
arterial stiffness, hemodialysis, intradialytic pedalling exercise, carotid-femoral pulse wave velocity, chronic kidney disease, hemodynamics, augmentation index
Brief summary
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.
Interventions
OTHERExercise
Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with end-stage renal disease (stage 5 CKD), who were on a stable in-center hemodialysis regimen (approximately 4 hours 3 times per week) for ≥ 12 weeks prior to recruitment * A cardiac evaluation was required within the last year to ensure adequate cardiac function
Exclusion criteria
* Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (e.g., hemiparesis, cerebellar ataxia, etc.) or dementia * Serum intact parathyroid hormone(iPTH)\>250 pmol/L within 30 days prior to screening visit * Dysrhythmia or severe cardiac disease, such as congestive heart failure (CHF) Class III-IV, or unstable cardiovascular disease within 90 days prior to recruitment * Severe peripheral arterial disease * Severe hyperkalemia (\>6.5 milliequivalent/L) consistently the last 2 weeks * Current active cancer (excluding basal cell carcinoma of the skin) * Poorly controlled hypertension (post-dialytic systolic blood pressure ≥ 160mmHg or diastolic blood pressure≥ 100 mmHg) within 4 weeks prior to recruitment * Anticipated living donor kidney transplant or any other planned major surgery over the study duration * History of poor treatment adherence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in non-invasive measures of arterial stiffness using applanation tonometry. | 4 months and 8 months after study initiation |
Secondary
| Measure | 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 |
| Safety and adverse events. | 8 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in low-density lipoprotein cholesterol levels | 4 months and 8 months after study initiation | Calculated using the Friedewald equation based on total cholesterol and high density lipoprotein cholesterol levels |
| 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 peripheral and central blood pressure using a oscillometric cuff-based approach. | 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 | — |
| Change in albumin levels | 4 months and 8 months after study initiation | — |
| Change in total cholesterol levels | 4 months and 8 months after study initiation | — |
| 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 | — |
Outcome results
None listed