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
NCT number | NCT03353844 |
Other study ID # | 139/60 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 9, 2017 |
Est. completion date | July 24, 2018 |
Verified date | July 2018 |
Source | Chulalongkorn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | King Chulalongkorn Memorial Hospital | Pathum Wan | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University |
Thailand,
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 |
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