Protein Supplementation for Chronic Stroke Treatment
- Conditions
- Chronic Stroke
- Interventions
- Dietary Supplement: Dietary supplementationOther: Exercise training
- Registration Number
- NCT03637270
- Lead Sponsor
- Taipei Medical University WanFang Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Chronic stroke>6months
- Age : 20-75 y
- Able to walk independently over 10 mins (with or without orthosis)
- Able to use stationary bike
- Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
- Not able to exercise due to severe cardiopulmonary dysfunction
- Malnutrition (MNA<11)
- Severe obesity (BMI>35)
- Renal insufficiency
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHO group Exercise training Participants in CHO group receive dietary supplementation with carbohydrate-rich supplements immediately before and after each exercise training session. The interventions include 30 training sessions. CHO group Dietary supplementation Participants in CHO group receive dietary supplementation with carbohydrate-rich supplements immediately before and after each exercise training session. The interventions include 30 training sessions. PRO group Dietary supplementation Participants in PRO group receive dietary supplementation with protein-rich supplements immediately before and after each exercise training session. The interventions include 30 training sessions. PRO group Exercise training Participants in PRO group receive dietary supplementation with protein-rich supplements immediately before and after each exercise training session. The interventions include 30 training sessions.
- Primary Outcome Measures
Name Time Method Cardiopulmonary capacity 10 weeks 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.
- Secondary Outcome Measures
Name Time Method CardioPulmonary Exercise Test 20 weeks measures cardiopulmonary fitness
Total body lean and fat mass 20 weeks measured by dual energy X-ray absorptiometry
Burg Balance Test 20 weeks measures the balance
Physical performance (short physical performance battery) 20 weeks measured by clinical evaluation
Timed up and go (TUG) 20 weeks measures the mixed capacity of balance and walking
6 minutes walk test 20 weeks measures the walking endurance
Physical performance (modified physical performance test) 20 weeks measured by clinical evaluation
Maximal isometric voluntary contraction 20 weeks measured by clinical evaluation
Trial Locations
- Locations (4)
Department of rehabilitation, Shuang-Ho Hospital
🇨🇳New Taipei City, Taiwan
Department of rehabilitation, WanFang Hospital
🇨🇳Taipei City, Taiwan
Department of rehabilitation, Taipei Tzu-Chi Hospital
🇨🇳New Taipei City, Taiwan
Department of rehabilitation, Taipei Medical University Hospital
🇨🇳Taipei, Taiwan