Clinical trial NCT03027778: Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
Official title: Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: arterial stiffness
hemodialysis
intradialytic pedalling exercise
carotid-femoral pulse wave velocity
chronic kidney disease
hemodynamics
augmentation index
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in non-invasive measures of arterial stiffness using applanation tonometry.
timeFrame: 4 months and 8 months after study initiation
Secondary outcomes:
measure: Change in gait speed using a 6 meter walk course and timer.
timeFrame: 4 months and 8 months after study initiation
measure: Change in grip strength using a hand dynamometer.
timeFrame: 4 months and 8 months after study initiation
measure: Safety and adverse events.
timeFrame: 8 months
Other outcomes:
measure: Change in peripheral and central blood pressure using a oscillometric cuff-based approach.
timeFrame: 4 months and 8 months after study initiation
measure: Change in total cholesterol levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in triglyceride levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in high density lipoprotein cholesterol levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in low-density lipoprotein cholesterol levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in hemoglobin levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in leukocyte levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in platelet levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in albumin levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in serum electrolyte levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in phosphate levels
timeFrame: 4 months and 8 months after study initiation
measure: Change in ferritin levels
timeFrame: 4 months and 8 months after study initiation
Locations:
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Stella S Daskalopoulou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.