Protein Supplementation for Chronic Stroke Treatment

Taipei Medical University

Status: Completed

Conditions: Chronic Stroke

Treatments: Dietary Supplement: Dietary supplementation; Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT03637270

107-2320-B-038 -016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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114 participants in 2 patient groups

PRO group

Experimental group

Description:

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.

Treatment:

Other: Exercise training

Dietary Supplement: Dietary supplementation

CHO group

Active Comparator group

Description:

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.

Treatment:

Other: Exercise training

Dietary Supplement: Dietary supplementation