Protein Supplementation for Chronic Stroke Treatment

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637270
• Other study ID #: 107-2320-B-038 -016
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

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