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The Effects of Intradialytic Exercise in Hemodiafiltration Patients

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ClinicalTrials.gov Identifier: NCT03353844
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Khajohn Tiranathanagul, 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).

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Hemodialysis Sedentary Lifestyle Behavioral: Intradialytic exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Intradialytic Exercise on Daily Physical Activity in Patients Undergoing Long-term High-efficiency Online Hemodiafiltration
Actual Study Start Date : November 9, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intradialytic exercise group
These patients will get intradialytic exercise every sessions of hemodiafiltration
Behavioral: Intradialytic exercise
intradialytic exercise which start and finish in first hour of hemodiafiltration session

No Intervention: Standard dialysis group
regular and standard of care in every hemodiafiltration sessions (as usual) without intradialytic exercise.



Primary Outcome Measures :
  1. Change of daily physical activity at 6 months [ Time Frame: 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 :
  1. Dialysis adequacy as measured by kt/V [ Time Frame: at 6 months ]
    Adequacy of dialysis will be monitor at baseline and 6 month

  2. Aerobic exercise capacity as measured by VO2 max [ Time Frame: at 6 months ]
    Aerobic exercise capacity parameters including VO2 max (maximal oxygen consumption) will be measured at baseline and 6 month

  3. Body composition (lean and fat body mass) [ Time Frame: at 6 months ]
    The baseline body composition measurements and body composition at 6 months will be measured by DXA scan and bioimpedance spectroscopy



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353844


Locations
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Thailand
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Principal Investigator: Khajohn Tiranathanagul, MD Chulalongkorn University
Principal Investigator: Nawaporn Assawasaksakul, MD Chulalongkorn University

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Responsible Party: Khajohn Tiranathanagul, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03353844     History of Changes
Other Study ID Numbers: 139/60
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency