<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/NCT04507152</url>
  </required_header>
  <id_info>
    <org_study_id>A-BR-108-111-T</org_study_id>
    <nct_id>NCT04507152</nct_id>
  </id_info>
  <brief_title>Blood Flow Restriction Training in Pre-frail and Frail Older Adults</brief_title>
  <official_title>Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng Kung University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Frailty is most often defined as a syndrome of physiological decline in late life,&#xD;
      characterized by marked vulnerability to adverse health outcomes. Intervention such as&#xD;
      exercise, especially resistance exercise, has proven to be effective to improve frail&#xD;
      condition in the elderly in the previous literature. However, blood flow restriction (BFR)&#xD;
      training, a new resistance exercise training method, need merely lower resistance power and&#xD;
      shorter training duration compared with traditional resistance exercise. Previous researches&#xD;
      also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but&#xD;
      the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this&#xD;
      study will test the effect of BFR training on muscle strength and functional performance in&#xD;
      pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score&#xD;
      between 3 to 5 will be recruited. Participants will be assigned to two groups using&#xD;
      randomized block design with BFR training and control group. Structured questionnaire and&#xD;
      physical function measurement will be used to assess the pre-intervention condition and&#xD;
      outcome of different interventions. The participants will be assessed before training&#xD;
      (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up&#xD;
      at one and three months after training. Physical function measurement will include hand grip,&#xD;
      muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and&#xD;
      timed up and go test. Two-way repeated measures analysis of variance will be used to test the&#xD;
      pre-test, 3-week, post-test and follow-ups difference between the two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Actual">November 26, 2021</completion_date>
  <primary_completion_date type="Actual">November 26, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of muscle strength of the lower extremities</measure>
    <time_frame>Before training, 3 and 6 weeks after training, and one and two months follow-ups</time_frame>
    <description>Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of 30 seconds sit to stand</measure>
    <time_frame>Before training, 3 and 6 weeks after training, and one and two months follow-ups</time_frame>
    <description>30 seconds sit to stand</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of timed-up-and-go test</measure>
    <time_frame>Before training, 3 and 6 weeks after training, and one and two months follow-ups</time_frame>
    <description>Timed-up-and-go test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of one-repetition maximum</measure>
    <time_frame>Before training, 3 and 6 weeks after training, and one and two months follow-ups</time_frame>
    <description>One-repetition maximum of step-ups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of muscle mass</measure>
    <time_frame>Before training, 3 and 6 weeks after training, and one and two months follow-ups</time_frame>
    <description>Muscle mass of the upper and lower extremities and trunk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of hand grip</measure>
    <time_frame>Before training, 3 and 6 weeks after training, and one and two months follow-ups</time_frame>
    <description>Bilateral hand grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of physical activity level</measure>
    <time_frame>Before training, 3 and 6 weeks after training, and one and two months follow-ups</time_frame>
    <description>The International Physical Activity Questionnaire (IPAQ)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Blood flow restriction resistance training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood flow restriction resistance training</intervention_name>
    <description>The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.</description>
    <arm_group_label>Blood flow restriction resistance training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance training</intervention_name>
    <description>The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.</description>
    <arm_group_label>Resistance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged over 60 years old&#xD;
&#xD;
          -  Fried frailty index fulfill 1-2 criteria&#xD;
&#xD;
          -  Able to walk 6 meters independently&#xD;
&#xD;
          -  Able to understand and follow ≥ 3 instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe hypertension (&gt;180/110mmHg)&#xD;
&#xD;
          -  Peripheral neuropathy&#xD;
&#xD;
          -  History of deep-vein thrombosis (DVT)&#xD;
&#xD;
          -  Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial&#xD;
             infarction, pulmonary hypertension, coronary artery stenosis)&#xD;
&#xD;
          -  Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)&#xD;
&#xD;
          -  History of resisted exercise training program within the last 6 months before&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan city</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>January 10, 2022</last_update_submitted>
  <last_update_submitted_qc>January 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng Kung University</investigator_affiliation>
    <investigator_full_name>Pei-Yun Lee</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Blood flow restriction</keyword>
  <keyword>Resistance exercise</keyword>
  <keyword>Frailty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04507152
org study id: A-BR-108-111-T
nct id: NCT04507152
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Frailty is most often defined as a syndrome of physiological decline in late life,
      characterized by marked vulnerability to adverse health outcomes. Intervention such as
      exercise, especially resistance exercise, has proven to be effective to improve frail
      condition in the elderly in the previous literature. However, blood flow restriction (BFR)
      training, a new resistance exercise training method, need merely lower resistance power and
      shorter training duration compared with traditional resistance exercise. Previous researches
      also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but
      the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this
      study will test the effect of BFR training on muscle strength and functional performance in
      pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score
      between 3 to 5 will be recruited. Participants will be assigned to two groups using
      randomized block design with BFR training and control group. Structured questionnaire and
      physical function measurement will be used to assess the pre-intervention condition and
      outcome of different interventions. The participants will be assessed before training
      (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up
      at one and three months after training. Physical function measurement will include hand grip,
      muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and
      timed up and go test. Two-way repeated measures analysis of variance will be used to test the
      pre-test, 3-week, post-test and follow-ups difference between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change of muscle strength of the lower extremities
time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
description: Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors
measure: Change of 30 seconds sit to stand
time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
description: 30 seconds sit to stand
measure: Change of timed-up-and-go test
time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
description: Timed-up-and-go test
measure: Change of one-repetition maximum
time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
description: One-repetition maximum of step-ups
measure: Change of muscle mass
time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
description: Muscle mass of the upper and lower extremities and trunk
measure: Change of hand grip
time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
description: Bilateral hand grip strength
measure: Change of physical activity level
time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
description: The International Physical Activity Questionnaire (IPAQ)
arm group label: Blood flow restriction resistance training
arm group type: Experimental
arm group label: Resistance training
arm group type: Active Comparator
intervention type: Other
intervention name: Blood flow restriction resistance training
description: The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.
arm group label: Blood flow restriction resistance training
intervention type: Other
intervention name: Resistance training
description: The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.
arm group label: Resistance training
criteria: 
gender: All
minimum age: 60 Years
maximum age: 95 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng Kung University
investigator full name: Pei-Yun Lee
investigator title: Assistant professor
mesh term: Frailty
sharing ipd: No