Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

Study Overview
=================
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.

Official Title
-----------------
Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

Conditions
-----------------
Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Participants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months. | Other: Exercise<br>* Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months<br>|
| No Intervention: Usual care<br>Participants receive their usual dialysis for the duration of 4 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in non-invasive measures of arterial stiffness using applanation tonometry. |  | 4 months and 8 months after study initiation | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Safety and adverse events. |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodynamics, arterial stiffness, hemodialysis, intradialytic pedalling exercise, carotid-femoral pulse wave velocity, chronic kidney disease, augmentation index