The Effects of Intradialytic Exercise in Hemodiafiltration Patients

Not Applicable

Completed

• Conditions: Hemodialysis; End Stage Renal Disease; Sedentary Lifestyle
• Interventions: Behavioral: Intradialytic exercise

• Registration Number: NCT03353844
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-11-08
• Study Start: 2017-11-09
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Primary Completion: 2018-06-30
• Status Verified: 2018-07
• Study Completion: 2018-07-24
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradialytic exercise group	Intradialytic exercise	These patients will get intradialytic exercise every sessions of hemodiafiltration

Primary Outcome Measures

Name	Time	Method
Change of daily physical activity at 6 months	at 0 and 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Pathum Wan, Bangkok, Thailand