Chronic Stroke
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDietary 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.
OTHERExercise training
Including aerobic cycling training and progressive resisted exercise
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go (TUG) | 20 weeks | measures the mixed capacity of balance and walking |
| Burg Balance Test | 20 weeks | measures the balance |
| CardioPulmonary Exercise Test | 20 weeks | measures cardiopulmonary fitness |
| Total body lean and fat mass | 20 weeks | measured by dual energy X-ray absorptiometry |
| Physical performance (short physical performance battery) | 20 weeks | measured by clinical evaluation |
| Physical performance (modified physical performance test) | 20 weeks | measured by clinical evaluation |
| Maximal isometric voluntary contraction | 20 weeks | measured by clinical evaluation |
| 6 minutes walk test | 20 weeks | measures the walking endurance |
Countries
Taiwan
Outcome results
None listed