Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

Official title:

Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027778
• Other study ID #: 12-309 GEN
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: March 20, 2018
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in peripheral and central blood pressure using a oscillometric cuff-based approach.		4 months and 8 months after study initiation
Other	Change in total cholesterol levels		4 months and 8 months after study initiation
Other	Change in triglyceride levels		4 months and 8 months after study initiation
Other	Change in high density lipoprotein cholesterol levels		4 months and 8 months after study initiation
Other	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
Other	Change in hemoglobin levels		4 months and 8 months after study initiation
Other	Change in leukocyte levels		4 months and 8 months after study initiation
Other	Change in platelet levels		4 months and 8 months after study initiation
Other	Change in albumin levels		4 months and 8 months after study initiation
Other	Change in serum electrolyte levels		4 months and 8 months after study initiation
Other	Change in phosphate levels		4 months and 8 months after study initiation
Other	Change in ferritin levels		4 months and 8 months after study initiation
Primary	Change in non-invasive measures of arterial stiffness using applanation tonometry.		4 months and 8 months after study initiation
Secondary	Change in gait speed using a 6 meter walk course and timer.		4 months and 8 months after study initiation
Secondary	Change in grip strength using a hand dynamometer.		4 months and 8 months after study initiation
Secondary	Safety and adverse events.		8 months