Use of BCAA-rich Protein Supplements for Chronic Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
BCAA supplement
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring BCAA, stroke, mobility
Eligibility Criteria
Inclusion Criteria:
- Chronic stroke>6months
- Age : 20-75 y
- Able to walk independently over 30 mins (with or without orthosis)
- Able to use stationary bike
Exclusion Criteria:
- Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
- Not able to exercise due to severe cardiopulmonary dysfunction
- Malnutrition (MNA<11)
Sites / Locations
- Shuang-Ho Hospital
- WanFang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BCAA group
Control group
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
DXA
Body fat scale
Secondary Outcome Measures
Timed up and go (TUG)
Burg Balance Test
CPET
Stroke Specific Quality of Life Scale(SS-QOL)
6 minutes walk test
Full Information
NCT ID
NCT03244527
First Posted
July 21, 2017
Last Updated
March 14, 2020
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03244527
Brief Title
Use of BCAA-rich Protein Supplements for Chronic Stroke Patients
Official Title
Use of BCAA-rich Protein Supplements for Chronic Stroke Patients to Improve the Functional Performance
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
BCAA, stroke, mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BCAA group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
BCAA supplement
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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 Measure Information:
Title
DXA
Time Frame
8 weeks after intervention
Title
Body fat scale
Time Frame
8 weeks after intervention
Secondary Outcome Measure Information:
Title
Timed up and go (TUG)
Time Frame
8 weeks after intervention
Title
Burg Balance Test
Time Frame
8 weeks after intervention
Title
CPET
Time Frame
8 weeks after intervention
Title
Stroke Specific Quality of Life Scale(SS-QOL)
Time Frame
8 weeks after intervention
Title
6 minutes walk test
Time Frame
8 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic stroke>6months
Age : 20-75 y
Able to walk independently over 30 mins (with or without orthosis)
Able to use stationary bike
Exclusion Criteria:
Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
Not able to exercise due to severe cardiopulmonary dysfunction
Malnutrition (MNA<11)
Facility Information:
Facility Name
Shuang-Ho Hospital
City
New Taipei City
Country
Taiwan
Facility Name
WanFang Hospital
City
Taipei City
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31879077
Citation
Cheng YH, Wei L, Chan WP, Hsu CY, Huang SW, Wang H, Lin YN. Effects of protein supplementation on aerobic training-induced gains in cardiopulmonary fitness, muscle mass, and functional performance in chronic stroke: A randomized controlled pilot study. Clin Nutr. 2020 Sep;39(9):2743-2750. doi: 10.1016/j.clnu.2019.12.013. Epub 2019 Dec 17.
Results Reference
derived
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Use of BCAA-rich Protein Supplements for Chronic Stroke Patients
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