The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients

Conditions
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End Stage Kidney Disease

Intervention / Treatment
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* Other: exercise


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intradialytic exercise<br>baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program | Other: exercise<br>* 12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run<br>* Other names: biking on hemodialysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic capacity | Aerobic capacity is measured as a function of the DASI score | 12 weeks | 
| 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. | 12 weeks | 
| Quality of life | The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks. | 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. | 12 weeks | 
| 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. | 12 weeks | 
| Hemoglobin levels | The baseline hemoglobin and hemoglobin at 12 weeks will be tracked. | 12 weeks | 
| Potassium levels | The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored. | 12 weeks | 
| Urea removal | The baseline and 12 week pre and post dialysis urea levels will be monitored. | 12 weeks | 
| Phosphate levels | The baseline and 12 week pre-dialysis phosphate levels will be tracked. | 12 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intradialytic exercise, hemodialysis