The Effects of Intradialytic Exercise in Hemodiafiltration Patients

Study Overview
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Brief Summary
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Low physical activity is associated with in hemodialysis and hemodiafiltration (HDF) patients. Previous studies showed the benefits of intradialytic exercise for improvement of physical fitness and hemodialysis adequacy. However, the effect of intradialytic exercise on physical activity has not been explored. This current open-labelled randomized controlled trial is conducted in HDF patients to determine the effect of intradialytic exercise program for 6 months on daily physical activity measured by tri-axial accelerometer (wearable device).

Detailed Description
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The study is an open-labelled randomized controlled trial which compare the changes of daily physical activity measured by tri-axial accelerometer (wearable device) between the HDF patients in intradialytic exercise group and control during the 6-month period. After inclusion in to the study, all of the participants will be evaluated before randomized. The investigators will prescribe the exercise program for each participant in the exercise group. The exercise program use intradialytic cycling which will be gradually increased to at least 30 minutes with moderate intensity. The participants in control group will receive dialysis as usual without intradialytic exercise prescription. The participants will go on the program for at least 6-months period. In each session, any adverse event or side effect will be reported.

Official Title
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The Effects of Intradialytic Exercise on Daily Physical Activity in Patients Undergoing Long-term High-efficiency Online Hemodiafiltration

Conditions
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End Stage Renal Disease, Hemodialysis, Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: Intradialytic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dialysis vintage more than 3 months Sedentary or light physical activity Exclusion Criteria: recent myocardial infarction (<12 months) recent ischemic stroke (<12months) uncontrolled comorbidities (diabetes/hypertension/heart failure/heart disease/respiratory disease) Life expectancy < 12 months active musculoskeletal problem e.g.) rheumatoid arthritis, spondyloarthropathy, osteoarthritis, fracture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradialytic exercise group<br>These patients will get intradialytic exercise every sessions of hemodiafiltration | Behavioral: Intradialytic exercise<br>* intradialytic exercise which start and finish in first hour of hemodiafiltration session<br>|
| No Intervention: Standard dialysis group<br>regular and standard of care in every hemodiafiltration sessions (as usual) without intradialytic exercise. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of daily physical activity at 6 months | Every participant will be monitored their daily physical activity by wearable tri-axial accelerometer (Fitbit) before and at 6 months to observe changes in daily physical activity. | at 0 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis adequacy as measured by kt/V | Adequacy of dialysis will be monitor at baseline and 6 month | at 6 months | 
| Aerobic exercise capacity as measured by VO2 max | Aerobic exercise capacity parameters including VO2 max (maximal oxygen consumption) will be measured at baseline and 6 month | at 6 months | 
| Body composition (lean and fat body mass) | The baseline body composition measurements and body composition at 6 months will be measured by DXA scan and bioimpedance spectroscopy | at 6 months |