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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03637270
Other study ID # 107-2320-B-038 -016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 19, 2018
Est. completion date April 3, 2023

Study information

Verified date June 2023
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stroke patients usually have difficulties with moving and are venerable to secondary problems such as sarcopenia and strength loss. These problems may accelerate the disability process during aging. It is well known that exercise helps to maintain or promote human fitness. This study is conducted to explore the beneficial effects of exercise and protein supplement on fitness and body composition among patients with chronic stroke.


Description:

This is a multicenter randomized control trial. Participants will be recruited from 4 teaching hospitals in Taipei. Participants are randomly assigned to 2 groups: 1. protein supplementation + exercise (PRO group); 2. carbohydrate supplementation + exercise (CHO group); The 1-hour exercise intervention includes aerobic cycling exercise followed by progressive resisted exercise with TheraBand. PRO group receives PS immediately before and after the exercise while the CHO group receive sham product (the same calories with no protein). The Interventions are arranged 3 sessions a week for 10 weeks. The outcome measurements are performed at 0-week, 10-week, and 20-week.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date April 3, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: 1. Chronic stroke>6months 2. Age : 20-75 y 3. Able to walk independently over 10 mins (with or without orthosis) 4. Able to use stationary bike Exclusion Criteria: 1. Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments. 2. Not able to exercise due to severe cardiopulmonary dysfunction 3. Malnutrition (MNA<11) 4. Severe obesity (BMI>35) 5. Renal insufficiency 6. Unable to tolerate our cardiopulmonary exercise test (CPET) (eg, too short stature to fit the machine, leg spasticity is too strong to peddle the cycling, unable to maintain 50 rpm at the beginning of CPET, indications for early termination of CPET based on the American College of Sport Medicine suggestions)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary supplementation
Before and after each exercise session, the research assistant will give subjects protein supplement or carbohydrate supplement according to the treatment assignment and ask them to drink it down right away.
Other:
Exercise training
Including aerobic cycling training and progressive resisted exercise

Locations

Country Name City State
Taiwan Department of rehabilitation, Shuang-Ho Hospital New Taipei City
Taiwan Department of rehabilitation, Taipei Tzu-Chi Hospital New Taipei City
Taiwan Department of rehabilitation, Taipei Medical University Hospital Taipei
Taiwan Department of rehabilitation, WanFang Hospital Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiopulmonary capacity VO2-peak. Oxygen consumption (VO2- peak) were measured during our cardiopulmonary test (with a ramped stationary biking and a gas analyzer). The workload was increased at a ramp rate of 5-10 W/min. A cadence at 50~70 rpm was to be maintained. 10 weeks
Secondary Total body lean and fat mass measured by dual energy X-ray absorptiometry 20 weeks
Secondary Timed up and go (TUG) measures the mixed capacity of balance and walking 20 weeks
Secondary Burg Balance Test measures the balance 20 weeks
Secondary CardioPulmonary Exercise Test measures cardiopulmonary fitness 20 weeks
Secondary 6 minutes walk test measures the walking endurance 20 weeks
Secondary Physical performance (short physical performance battery) measured by clinical evaluation 20 weeks
Secondary Physical performance (modified physical performance test) measured by clinical evaluation 20 weeks
Secondary Maximal isometric voluntary contraction measured by clinical evaluation 20 weeks
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