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Use of Branched Chain Amino Acid (BCAA) Supplements for Chronic Stroke Patients

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ClinicalTrials.gov Identifier: NCT03244527
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Yen-Nung Lin, Taipei Medical University WanFang Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Stroke Dietary Supplement: BCAA supplement Other: Aerobic exercise Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Branched Chain Amino Acid (BCAA) Supplements for Chronic Stroke Patients to Improve the Functional Performance
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : August 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BCAA group
Participants in the BCAA group take 40g of BCAA supplement before each aerobic exercise session. The interventions include 24 aerobic training sessions. Accordingly, the participants intake 960g of BCAA during a 8-week intervention period.
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.

Placebo Comparator: Control group
Participants in the control group take 40g of placebo before each aerobic training session. The placebo has the same caloric as the BCAA supplement but with different constitution (eg, different percentage of protein, fat and carbohydrate)
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.




Primary Outcome Measures :
  1. DXA [ Time Frame: 8 weeks after intervention ]
  2. Body fat scale [ Time Frame: 8 weeks after intervention ]

Secondary Outcome Measures :
  1. Timed up and go (TUG) [ Time Frame: 8 weeks after intervention ]
  2. Burg Balance Test [ Time Frame: 8 weeks after intervention ]
  3. CPET [ Time Frame: 8 weeks after intervention ]
  4. Stroke Specific Quality of Life Scale(SS-QOL) [ Time Frame: 8 weeks after intervention ]
  5. 6 minutes walk test [ Time Frame: 8 weeks after intervention ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244527


Locations
Taiwan
Shuang-Ho Hospital
New Taipei City, Taiwan
WanFang Hospital
Taipei City, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital

Responsible Party: Yen-Nung Lin, Medical doctor of Department of Physical Medicine & Rehabilitation, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT03244527     History of Changes
Other Study ID Numbers: N201703029
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yen-Nung Lin, Taipei Medical University WanFang Hospital:
BCAA
stroke
mobility

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases