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临床试验/NCT03244527
NCT03244527已完成不适用

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

Taipei Medical University WanFang Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
DXA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: BCAA supplement (Dietary Supplement)

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.

干预措施: Aerobic exercise (Other)

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)

干预措施: BCAA supplement (Dietary Supplement)

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)

干预措施: Aerobic exercise (Other)

结局指标

主要结局

DXA

时间窗: 8 weeks after intervention

Body fat scale

时间窗: 8 weeks after intervention

次要结局

  • Burg Balance Test(8 weeks after intervention)
  • Timed up and go (TUG)(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yen-Nung Lin

Medical doctor of Department of Physical Medicine & Rehabilitation

Taipei Medical University WanFang Hospital

研究点 (2)

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