Back to resultsThe Effects of Intradialytic Exercise in Hemodiafiltration Patients
Primary Purpose
End Stage Renal Disease, Hemodialysis, Sedentary Lifestyle
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Intradialytic exercise
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility 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
Sites / Locations
- King Chulalongkorn Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intradialytic exercise group
Standard dialysis group
Arm Description
These patients will get intradialytic exercise every sessions of hemodiafiltration
regular and standard of care in every hemodiafiltration sessions (as usual) without intradialytic exercise.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Dialysis adequacy as measured by kt/V
Adequacy of dialysis will be monitor at baseline and 6 month
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
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
Full Information
NCT ID
NCT03353844
First Posted
November 8, 2017
Last Updated
July 24, 2018
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT03353844
Brief Title
The Effects of Intradialytic Exercise in Hemodiafiltration Patients
Official Title
The Effects of Intradialytic Exercise on Daily Physical Activity in Patients Undergoing Long-term High-efficiency Online Hemodiafiltration
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemodialysis, Sedentary Lifestyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intradialytic exercise group
Arm Type
Experimental
Arm Description
These patients will get intradialytic exercise every sessions of hemodiafiltration
Arm Title
Standard dialysis group
Arm Type
No Intervention
Arm Description
regular and standard of care in every hemodiafiltration sessions (as usual) without intradialytic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Intradialytic exercise
Intervention Description
intradialytic exercise which start and finish in first hour of hemodiafiltration session
Primary Outcome Measure Information:
Title
Change of daily physical activity at 6 months
Description
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.
Time Frame
at 0 and 6 months
Secondary Outcome Measure Information:
Title
Dialysis adequacy as measured by kt/V
Description
Adequacy of dialysis will be monitor at baseline and 6 month
Time Frame
at 6 months
Title
Aerobic exercise capacity as measured by VO2 max
Description
Aerobic exercise capacity parameters including VO2 max (maximal oxygen consumption) will be measured at baseline and 6 month
Time Frame
at 6 months
Title
Body composition (lean and fat body mass)
Description
The baseline body composition measurements and body composition at 6 months will be measured by DXA scan and bioimpedance spectroscopy
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khajohn Tiranathanagul, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nawaporn Assawasaksakul, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
33128722
Citation
Assawasaksakul N, Sirichana W, Joosri W, Kulaputana O, Eksakulkla S, Ketanun C, Kittiskulnam P, Chantadisai M, Takkavatakarn K, Susantitaphong P, Praditpornsilpa K, Eiam-Ong S, Tiranathanagul K. Effects of intradialytic cycling exercise on daily physical activity, physical fitness, body composition, and clinical parameters in high-volume online hemodiafiltration patients: a pilot randomized-controlled trial. Int Urol Nephrol. 2021 Feb;53(2):359-371. doi: 10.1007/s11255-020-02677-7. Epub 2020 Oct 31.
Results Reference
derived
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The Effects of Intradialytic Exercise in Hemodiafiltration Patients
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