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Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

Primary Purpose

Chronic Kidney Disease Requiring Chronic Dialysis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional prevention trial for Chronic Kidney Disease Requiring Chronic Dialysis focused on measuring arterial stiffness, hemodialysis, intradialytic pedalling exercise, carotid-femoral pulse wave velocity, chronic kidney disease, hemodynamics, augmentation index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Usual care

Arm Description

Participants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months.

Participants receive their usual dialysis for the duration of 4 months.

Outcomes

Primary Outcome Measures

Change in non-invasive measures of arterial stiffness using applanation tonometry.

Secondary Outcome Measures

Change in gait speed using a 6 meter walk course and timer.

Change in grip strength using a hand dynamometer.

Safety and adverse events.

Full Information

NCT ID

NCT03027778

First Posted

January 17, 2017

Last Updated

March 20, 2018

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

1. Study Identification

Unique Protocol Identification Number

NCT03027778

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

arterial stiffness, hemodialysis, intradialytic pedalling exercise, carotid-femoral pulse wave velocity, chronic kidney disease, hemodynamics, augmentation index

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Participants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months.

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Participants receive their usual dialysis for the duration of 4 months.

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months

Primary Outcome Measure Information:

Title

Change in non-invasive measures of arterial stiffness using applanation tonometry.

Time Frame

4 months and 8 months after study initiation

Secondary Outcome Measure Information:

Title

Change in gait speed using a 6 meter walk course and timer.

Time Frame

4 months and 8 months after study initiation

Title

Change in grip strength using a hand dynamometer.

Time Frame

4 months and 8 months after study initiation

Title

Safety and adverse events.

Time Frame

8 months

Other Pre-specified Outcome Measures:

Title

Change in peripheral and central blood pressure using a oscillometric cuff-based approach.

Time Frame

4 months and 8 months after study initiation

Title

Change in total cholesterol levels

Time Frame

4 months and 8 months after study initiation

Title

Change in triglyceride levels

Time Frame

4 months and 8 months after study initiation

Title

Change in high density lipoprotein cholesterol levels

Time Frame

4 months and 8 months after study initiation

Title

Change in low-density lipoprotein cholesterol levels

Description

Calculated using the Friedewald equation based on total cholesterol and high density lipoprotein cholesterol levels

Time Frame

4 months and 8 months after study initiation

Title

Change in hemoglobin levels

Time Frame

4 months and 8 months after study initiation

Title

Change in leukocyte levels

Time Frame

4 months and 8 months after study initiation

Title

Change in platelet levels

Time Frame

4 months and 8 months after study initiation

Title

Change in albumin levels

Time Frame

4 months and 8 months after study initiation

Title

Change in serum electrolyte levels

Time Frame

4 months and 8 months after study initiation

Title

Change in phosphate levels

Time Frame

4 months and 8 months after study initiation

Title

Change in ferritin levels

Time Frame

4 months and 8 months after study initiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stella S Daskalopoulou, MD, PhD

Organizational Affiliation

McGill University Health Centre/Research Institute of the McGill University Health Centre

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35018639

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.

Results Reference

derived

PubMed Identifier

29126178

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.

Results Reference

derived

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Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

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