The Effects of Intradialytic Exercise in Hemodiafiltration Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-09

Study Completion Date

2018-07-24

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).

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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.

Conditions

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End Stage Renal Disease Hemodialysis Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intradialytic exercise group

These patients will get intradialytic exercise every sessions of hemodiafiltration

Group Type EXPERIMENTAL

Intradialytic exercise

Intervention Type BEHAVIORAL

intradialytic exercise which start and finish in first hour of hemodiafiltration session

Standard dialysis group

regular and standard of care in every hemodiafiltration sessions (as usual) without intradialytic exercise.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intradialytic exercise

intradialytic exercise which start and finish in first hour of hemodiafiltration session

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No