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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intradialytic exercise group | Experimental | These patients will get intradialytic exercise every sessions of hemodiafiltration |
|
| Standard dialysis group | No Intervention | regular and standard of care in every hemodiafiltration sessions (as usual) without intradialytic exercise. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradialytic exercise | Behavioral | intradialytic exercise which start and finish in first hour of hemodiafiltration session |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis adequacy as measured by kt/V | Adequacy of dialysis will be monitor at baseline and 6 month | at 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khajohn Tiranathanagul, MD | Chulalongkorn University | Principal Investigator |
| Nawaporn Assawasaksakul, MD | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Pathum Wan | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33128722 | Derived | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| at 6 months |
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |