The Effects of Intradialytic Exercise in Hemodiafiltration Patients

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353844
• Other study ID #: 139/60
• Status: Completed
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: July 24, 2018

Study information

• Verified date: July 2018
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 24, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic
• Sedentary Lifestyle

Intervention

Behavioral:
• Intradialytic exercise
intradialytic exercise which start and finish in first hour of hemodiafiltration session

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dialysis adequacy as measured by kt/V	Adequacy of dialysis will be monitor at baseline and 6 month	at 6 months
Secondary	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
Secondary	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