Use of BCAA-rich Protein Supplements for Chronic Stroke Patients

NCT03244527 | Completed

• 1 other identifier: N201703029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

BCAA; stroke; mobility

Outcome Measures

Primary Outcomes (2)

• DXA

  8 weeks after intervention

• Body fat scale

  8 weeks after intervention

Secondary Outcomes (5)

• Timed up and go (TUG)

  8 weeks after intervention

• Burg Balance Test

  8 weeks after intervention

• CPET

  8 weeks after intervention

• Stroke Specific Quality of Life Scale(SS-QOL)

  8 weeks after intervention

• 6 minutes walk test

  8 weeks after intervention

Study Arms (2)

BCAA group

EXPERIMENTAL

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; Other: Aerobic exercise

Control group

PLACEBO COMPARATOR

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; Other: Aerobic exercise

Interventions

BCAA supplement DIETARY_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.

BCAA group; Control group

Aerobic exercise OTHER

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.

BCAA group; Control group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic stroke\>6months
• Age : 20-75 y
• Able to walk independently over 30 mins (with or without orthosis)
• Able to use stationary bike

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (2)

Shuang-Ho Hospital

New Taipei City, Taiwan

Location

WanFang Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31879077 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor of Department of Physical Medicine & Rehabilitation

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: August 9, 2017
• Study Start: August 29, 2017
• Primary Completion: August 2, 2018
• Study Completion: August 5, 2018
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

TW (2)