Back to resultsThe Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
Primary Purpose
End Stage Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Kidney Disease focused on measuring intradialytic exercise, hemodialysis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Compromised cardiac profiles
- Hemodynamic instability
- Severe bone disease
- Medical conditions which contraindicate exercise
Sites / Locations
- Northwest Dialysis Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intradialytic exercise
Arm Description
baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Aerobic capacity
Aerobic capacity is measured as a function of the DASI score
Strength
Strength is determined as bilateral hand grip strength (measured in kg) as well as by the 30 second sit to stand test(the number of repetitions achieved in 30 seconds). These measures are obtained at baseline and again at 12 weeks.
Quality of life
The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.
Hospitalizations
The number and rate of hospitalizations will be determined prior to exercise start and during the 12 week exercise program. Length of stay is also tracked.
Hypotension
Intradialytic hypotension, defined as a drop in systolic blood pressure (SBP) of 20 mmHg for patients with pre-dialysis blood pressure > 100 mmHg or a drop in SBP of 10 mmHg for patients with pre-dialysis blood pressure < = 90 mmHg. IDH with patient symptoms and nursing interventions will be obtained as well.
Hemoglobin levels
The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.
Potassium levels
The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.
Urea removal
The baseline and 12 week pre and post dialysis urea levels will be monitored.
Phosphate levels
The baseline and 12 week pre-dialysis phosphate levels will be tracked.
Bioimpedance derived volume and body mass determinations
In a small subset of patients (n=10) the bioimpedance derived fluid compartments (ECF, ICF, E:I ratio) and fat free body mass will be determined at both baseline and 12 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01877863
Brief Title
The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
Official Title
The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease
Keywords
intradialytic exercise, hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intradialytic exercise
Arm Type
Experimental
Arm Description
baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program
Intervention Type
Other
Intervention Name(s)
exercise
Other Intervention Name(s)
intradialytic exercise, intradialytic biking, biking on hemodialysis
Intervention Description
12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run
Primary Outcome Measure Information:
Title
Functional Capacity
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Aerobic capacity
Description
Aerobic capacity is measured as a function of the DASI score
Time Frame
12 weeks
Title
Strength
Description
Strength is determined as bilateral hand grip strength (measured in kg) as well as by the 30 second sit to stand test(the number of repetitions achieved in 30 seconds). These measures are obtained at baseline and again at 12 weeks.
Time Frame
12 weeks
Title
Quality of life
Description
The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.
Time Frame
12 weeks
Title
Hospitalizations
Description
The number and rate of hospitalizations will be determined prior to exercise start and during the 12 week exercise program. Length of stay is also tracked.
Time Frame
12 weeks
Title
Hypotension
Description
Intradialytic hypotension, defined as a drop in systolic blood pressure (SBP) of 20 mmHg for patients with pre-dialysis blood pressure > 100 mmHg or a drop in SBP of 10 mmHg for patients with pre-dialysis blood pressure < = 90 mmHg. IDH with patient symptoms and nursing interventions will be obtained as well.
Time Frame
12 weeks
Title
Hemoglobin levels
Description
The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.
Time Frame
12 weeks
Title
Potassium levels
Description
The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.
Time Frame
12 weeks
Title
Urea removal
Description
The baseline and 12 week pre and post dialysis urea levels will be monitored.
Time Frame
12 weeks
Title
Phosphate levels
Description
The baseline and 12 week pre-dialysis phosphate levels will be tracked.
Time Frame
12 weeks
Title
Bioimpedance derived volume and body mass determinations
Description
In a small subset of patients (n=10) the bioimpedance derived fluid compartments (ECF, ICF, E:I ratio) and fat free body mass will be determined at both baseline and 12 weeks.
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Compromised cardiac profiles
Hemodynamic instability
Severe bone disease
Medical conditions which contraindicate exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer MacRae
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Dialysis Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2L 2J8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
We'll reach out to this number within 24 hrs