The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT01877863|
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : March 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|End Stage Kidney Disease||Other: exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||December 2013|
Experimental: intradialytic exercise
baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program
12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run
- Functional Capacity [ Time Frame: 12 weeks ]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.
- Aerobic capacity [ Time Frame: 12 weeks ]Aerobic capacity is measured as a function of the DASI score
- Strength [ Time Frame: 12 weeks ]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 [ Time Frame: 12 weeks ]The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.
- Hospitalizations [ Time Frame: 12 weeks ]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 [ Time Frame: 12 weeks ]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 [ Time Frame: 12 weeks ]The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.
- Potassium levels [ Time Frame: 12 weeks ]The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.
- Urea removal [ Time Frame: 12 weeks ]The baseline and 12 week pre and post dialysis urea levels will be monitored.
- Phosphate levels [ Time Frame: 12 weeks ]The baseline and 12 week pre-dialysis phosphate levels will be tracked.
- Bioimpedance derived volume and body mass determinations [ Time Frame: 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877863
|Northwest Dialysis Centre|
|Calgary, Alberta, Canada, T2L 2J8|
|Principal Investigator:||Jennifer MacRae||University of Calgary|