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NCT Number: NCT03353844

The Effects of Intradialytic Exercise in Hemodiafiltration Patients

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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Key information

Conditions

End Stage Renal Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sedentary Behavior Sedentary Lifestyle Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intradialytic Exercise

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2017
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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