The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension. The investigators would also like to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned outcomes will positively improve over the twelve week intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 27, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedMarch 20, 2014
March 1, 2014
7 months
May 27, 2013
March 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Capacity
Functional capacity is measured by the DASI score which gives an estimated V02 peak in ml/min/kg. The difference between the mean score at baseline and 12 weeks will be determined.
12 weeks
Secondary Outcomes (10)
Aerobic capacity
12 weeks
Strength
12 weeks
Quality of life
12 weeks
Hospitalizations
12 weeks
Hypotension
12 weeks
- +5 more secondary outcomes
Study Arms (1)
intradialytic exercise
EXPERIMENTALbaseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program
Interventions
12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run
Eligibility Criteria
You may qualify if:
- Cardiac and hemodynamic stability
- Absence of severe musculoskeletal impairment
- Increased musculoskeletal weakness
- Vital signs within normal range for exercise
- Desire/motivated to exercise
- Clearance from nephrologist and Kinesiologist
You may not qualify if:
- Compromised cardiac profiles
- Hemodynamic instability
- Severe bone disease
- Medical conditions which contraindicate exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwest Dialysis Centre
Calgary, Alberta, T2L 2J8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer MacRae
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 27, 2013
First Posted
June 14, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2013
Last Updated
March 20, 2014
Record last verified: 2014-03