Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise; 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; Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months
NO_INTERVENTION: Usual care; Participants receive their usual dialysis for the duration of 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Stella S Daskalopoulou, MD, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (ESTIMATE): January 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: chronic kidney disease; hemodynamics; hemodialysis; arterial stiffness; augmentation index; intradialytic pedalling exercise; carotid-femoral pulse wave velocity
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 12-309 GEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO