Clinical trial NCT03637270: Protein Supplementation for Chronic Stroke Treatment
Official title: Incorporating Supplementary Protein Into Rehabilitative Exercise (INSPIRE Trial) for Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cardiopulmonary capacity
timeFrame: 10 weeks
Secondary outcomes:
measure: Total body lean and fat mass
timeFrame: 20 weeks
measure: Timed up and go (TUG)
timeFrame: 20 weeks
measure: Burg Balance Test
timeFrame: 20 weeks
measure: CardioPulmonary Exercise Test
timeFrame: 20 weeks
measure: 6 minutes walk test
timeFrame: 20 weeks
measure: Physical performance (short physical performance battery)
timeFrame: 20 weeks
measure: Physical performance (modified physical performance test)
timeFrame: 20 weeks
measure: Maximal isometric voluntary contraction
timeFrame: 20 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of rehabilitation, Shuang-Ho Hospital
city: New Taipei City
country: Taiwan
facility: Department of rehabilitation, Taipei Tzu-Chi Hospital
city: Taipei City
country: Taiwan
facility: Department of rehabilitation, WanFang Hospital
city: Taipei
country: Taiwan
facility: Department of rehabilitation, Taipei Medical University Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical Univerisity
name: Yen-Nung Lin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: