Use of BCAA-rich Protein Supplements for Chronic Stroke Patients

Stroke Clinical Trial

Official title:

Use of BCAA-rich Protein Supplements for Chronic Stroke Patients to Improve the Functional Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244527
• Other study ID #: N201703029
• Status: Completed
• Phase: N/A
• Start date: August 29, 2017
• Est. completion date: August 5, 2018

Study information

• Verified date: March 2020
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the past few years, Branched Chain Amino Acid (BCAA) supplements have gradually used on different groups. From training athletes, maintaining functions of healthy elders to preventing disabilities of people that can't do intense exercises. BCAAs are now considered to be able to prevent muscle atrophy and strength loss, also possible to increase strength and muscle mass if combined with resistance exercises. Stroke patients have difficulties with moving, which led to multiple disabilities, are more likely to have sarcopenia and strength loss. Furthermore, reducing the will of moving or walking. Recently, studies showed that combined BCAAs with resistance exercises can effectively increase muscle mass, thus commonly used on training athletes.

Although aerobic exercises are proven to be more likely to improve walking ability of chronic stroke patients than traditional rehabilitation, BCAAs' effects are yet to be proven. Therefore, the aim of this study is to explore if BCAAs combined with moderate intensity exercises can prevent muscle atrophy, loss of strength and cardiopulmonary function.

This is a randomized control trial. Participants are randomly assigned to either experiment or control groups. Both group received aerobic exercise (30 min in a session, 3 days a week, and for 8 weeks). Experiment group received BCAA supplement immediately after the exercise while the control group receive sham product (vitamins). The outcome measurements (including muscle mass, functional measures, and quality of life) are performed before (0-wk) and after (8-wk) the interventions, also after interventions in 3 months and 6 months for follow up.

Description:

Setting : inpatient rehabilitation department of Wan-Fang Hospital and Shuang-Ho Hospital Study population : Patients received inpatient treatment or rehabilitation for stroke in Wan-Fang Hospital (WFH) and Shuang-Ho Hospital (SHH).

Study design: controlled trial with randomization Blinding : The patients were blinded by the real or sham bcaa supplements. The assessors who performed the outcome measurements were blinded to the assignment of treatment.

Measurements : DXA(Dual-energy X-ray absorptiometry),CPET(Cardiopulmonary Exercise Testing),6 minute walk test,Timed up and go,Berg balance test,Stroke Specific Quality of Life Scale (SS-QOL).

These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.

Compliance and side effect. The compliance of supplements were investigated. The attendance of treatments (including bcaa supplements and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 5, 2018
• Est. primary completion date: August 2, 2018
• 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 30 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)

Related Conditions & MeSH terms

• Stroke

Intervention

Dietary Supplement:
• BCAA supplement
Before each exercise session (described later), the research assistant will give subjects 40g of BCAA or placebo supplement according to the treatment assignment and ask them to drink it down right away.

Other:
• Aerobic exercise
The exercise intervention includes 24 aerobic stationary cycling sessions (30 min/session, 3 session/week, and 8 weeks). The exercise sessions proceed under the supervision and guidance of a therapist.

Locations

Country	Name	City	State
Taiwan	Shuang-Ho Hospital	New Taipei City
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	DXA		8 weeks after intervention
Primary	Body fat scale		8 weeks after intervention
Secondary	Timed up and go (TUG)		8 weeks after intervention
Secondary	Burg Balance Test		8 weeks after intervention
Secondary	CPET		8 weeks after intervention
Secondary	Stroke Specific Quality of Life Scale(SS-QOL)		8 weeks after intervention
Secondary	6 minutes walk test		8 weeks after intervention