Clinical trial NCT03353844: 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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Hemodialysis
Sedentary Lifestyle
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of daily physical activity at 6 months
timeFrame: at 0 and 6 months
Secondary outcomes:
measure: Dialysis adequacy as measured by kt/V
timeFrame: at 6 months
measure: Aerobic exercise capacity as measured by VO2 max
timeFrame: at 6 months
measure: Body composition (lean and fat body mass)
timeFrame: at 6 months
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Khajohn Tiranathanagul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Nawaporn Assawasaksakul, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.