Protein Supplementation for Chronic Stroke Treatment

Study Overview
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Brief Summary
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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
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This is a multicenter randomized control trial. Participants will be recruited from 4 teaching hospitals in Taipei. Participants are randomly assigned to 2 groups: protein supplementation + exercise (PRO group); 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.

Official Title
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Incorporating Supplementary Protein Into Rehabilitative Exercise (INSPIRE Trial) for Patients With Chronic Stroke

Conditions
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Chronic Stroke

Intervention / Treatment
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* Dietary Supplement: Dietary supplementation
* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic stroke>6months Age : 20-75 y Able to walk independently over 10 mins (with or without orthosis) Able to use stationary bike Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO group<br>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. | Dietary Supplement: Dietary supplementation<br>* 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.<br>Other: Exercise training<br>* Including aerobic cycling training and progressive resisted exercise<br>|
| Active Comparator: CHO group<br>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. | Dietary Supplement: Dietary supplementation<br>* 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.<br>Other: Exercise training<br>* Including aerobic cycling training and progressive resisted exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body lean and fat mass | measured by dual energy X-ray absorptiometry | 20 weeks | 
| Timed up and go (TUG) | measures the mixed capacity of balance and walking | 20 weeks | 
| Burg Balance Test | measures the balance | 20 weeks | 
| CardioPulmonary Exercise Test | measures cardiopulmonary fitness | 20 weeks | 
| 6 minutes walk test | measures the walking endurance | 20 weeks | 
| Physical performance (short physical performance battery) | measured by clinical evaluation | 20 weeks | 
| Physical performance (modified physical performance test) | measured by clinical evaluation | 20 weeks | 
| Maximal isometric voluntary contraction | measured by clinical evaluation | 20 weeks |