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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03637270
Other study ID # 107-2320-B-038 -016
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date October 15, 2020

Study information

Verified date October 2018
Source Taipei Medical University WanFang Hospital
Contact Yen-Nung Lin, MD, MS
Phone 0970746879
Email semitune@gmail.com
Is FDA regulated No
Health authority
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 Not yet recruiting
Enrollment 120
Est. completion date October 15, 2020
Est. primary completion date October 15, 2020
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. History of renal insufficiency

Study Design


Related Conditions & MeSH terms


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 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 Physical performance measured by clinical evaluation 20 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 Stroke Specific Quality of Life Scale(SS-QOL) measures the health-related quality of life specific to patients with stroke 20 weeks
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