<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03244527</url>
  </required_header>
  <id_info>
    <org_study_id>N201703029</org_study_id>
    <nct_id>NCT03244527</nct_id>
  </id_info>
  <brief_title>Use of BCAA-rich Protein Supplements for Chronic Stroke Patients</brief_title>
  <official_title>Use of BCAA-rich Protein Supplements for Chronic Stroke Patients to Improve the Functional Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the past few years, Branched Chain Amino Acid (BCAA) supplements have gradually used on&#xD;
      different groups. From training athletes, maintaining functions of healthy elders to&#xD;
      preventing disabilities of people that can't do intense exercises. BCAAs are now considered&#xD;
      to be able to prevent muscle atrophy and strength loss, also possible to increase strength&#xD;
      and muscle mass if combined with resistance exercises. Stroke patients have difficulties with&#xD;
      moving, which led to multiple disabilities, are more likely to have sarcopenia and strength&#xD;
      loss. Furthermore, reducing the will of moving or walking. Recently, studies showed that&#xD;
      combined BCAAs with resistance exercises can effectively increase muscle mass, thus commonly&#xD;
      used on training athletes.&#xD;
&#xD;
      Although aerobic exercises are proven to be more likely to improve walking ability of chronic&#xD;
      stroke patients than traditional rehabilitation, BCAAs' effects are yet to be proven.&#xD;
      Therefore, the aim of this study is to explore if BCAAs combined with moderate intensity&#xD;
      exercises can prevent muscle atrophy, loss of strength and cardiopulmonary function.&#xD;
&#xD;
      This is a randomized control trial. Participants are randomly assigned to either experiment&#xD;
      or control groups. Both group received aerobic exercise (30 min in a session, 3 days a week,&#xD;
      and for 8 weeks). Experiment group received BCAA supplement immediately after the exercise&#xD;
      while the control group receive sham product (vitamins). The outcome measurements (including&#xD;
      muscle mass, functional measures, and quality of life) are performed before (0-wk) and after&#xD;
      (8-wk) the interventions, also after interventions in 3 months and 6 months for follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Setting : inpatient rehabilitation department of Wan-Fang Hospital and Shuang-Ho Hospital&#xD;
      Study population : Patients received inpatient treatment or rehabilitation for stroke in&#xD;
      Wan-Fang Hospital (WFH) and Shuang-Ho Hospital (SHH).&#xD;
&#xD;
      Study design: controlled trial with randomization Blinding : The patients were blinded by the&#xD;
      real or sham bcaa supplements. The assessors who performed the outcome measurements were&#xD;
      blinded to the assignment of treatment.&#xD;
&#xD;
      Measurements : DXA(Dual-energy X-ray absorptiometry),CPET(Cardiopulmonary Exercise Testing),6&#xD;
      minute walk test,Timed up and go,Berg balance test,Stroke Specific Quality of Life Scale&#xD;
      (SS-QOL).&#xD;
&#xD;
      These measurements (including the clinical and corticomotor excitability assessments) are&#xD;
      performed by one researcher who are responsible for the measurements.&#xD;
&#xD;
      Compliance and side effect. The compliance of supplements were investigated. The attendance&#xD;
      of treatments (including bcaa supplements and physical therapy sessions) and possible side&#xD;
      effect/discomfort were recorded during the interventions by a researcher. He also tries to&#xD;
      understand the reason of drop-out from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 29, 2017</start_date>
  <completion_date type="Actual">August 5, 2018</completion_date>
  <primary_completion_date type="Actual">August 2, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DXA</measure>
    <time_frame>8 weeks after intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body fat scale</measure>
    <time_frame>8 weeks after intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed up and go (TUG)</measure>
    <time_frame>8 weeks after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burg Balance Test</measure>
    <time_frame>8 weeks after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CPET</measure>
    <time_frame>8 weeks after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Specific Quality of Life Scale(SS-QOL)</measure>
    <time_frame>8 weeks after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minutes walk test</measure>
    <time_frame>8 weeks after intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>BCAA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BCAA supplement</intervention_name>
    <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.</description>
    <arm_group_label>BCAA group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic exercise</intervention_name>
    <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.</description>
    <arm_group_label>BCAA group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronic stroke&gt;6months&#xD;
&#xD;
          2. Age : 20-75 y&#xD;
&#xD;
          3. Able to walk independently over 30 mins (with or without orthosis)&#xD;
&#xD;
          4. Able to use stationary bike&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physiological condition not stable, cognitive dysfunction, not able to coordinate with&#xD;
             examine or treatments.&#xD;
&#xD;
          2. Not able to exercise due to severe cardiopulmonary dysfunction&#xD;
&#xD;
          3. Malnutrition (MNA&lt;11)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shuang-Ho Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WanFang Hospital</name>
      <address>
        <city>Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>March 14, 2020</last_update_submitted>
  <last_update_submitted_qc>March 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University WanFang Hospital</investigator_affiliation>
    <investigator_full_name>Yen-Nung Lin</investigator_full_name>
    <investigator_title>Medical doctor of Department of Physical Medicine &amp; Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>BCAA</keyword>
  <keyword>stroke</keyword>
  <keyword>mobility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03244527
org study id: N201703029
nct id: NCT03244527
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: DXA
time frame: 8 weeks after intervention
measure: Body fat scale
time frame: 8 weeks after intervention
measure: Timed up and go (TUG)
time frame: 8 weeks after intervention
measure: Burg Balance Test
time frame: 8 weeks after intervention
measure: CPET
time frame: 8 weeks after intervention
measure: Stroke Specific Quality of Life Scale(SS-QOL)
time frame: 8 weeks after intervention
measure: 6 minutes walk test
time frame: 8 weeks after intervention
arm group label: BCAA group
arm group type: Experimental
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 group label: Control group
arm group type: Placebo Comparator
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: BCAA supplement
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.
arm group label: BCAA group
arm group label: Control group
intervention type: Other
intervention name: Aerobic exercise
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.
arm group label: BCAA group
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University WanFang Hospital
investigator full name: Yen-Nung Lin
investigator title: Medical doctor of Department of Physical Medicine & Rehabilitation
mesh term: Stroke