<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/NCT04497480</url>
  </required_header>
  <id_info>
    <org_study_id>2020（001）</org_study_id>
    <nct_id>NCT04497480</nct_id>
  </id_info>
  <brief_title>The Extremities Rehabilitation Training System for Sarcopenic Hospitalized Aged 80+ Years</brief_title>
  <official_title>Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation System for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuxiang Liang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</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>
      Most previous clinical trials that addressed the rehabilitation training system for&#xD;
      sarcopenic elderly subjects focused on community-dwelling older adults who were relatively&#xD;
      healthy. There is a notable paucity of high-quality research investigating the effects and&#xD;
      feasibility of the device for hospitalized or institutionalized older people, who are&#xD;
      generally frailer and more severe in functional impairment than those living in the&#xD;
      community. Moreover, most reported the system were of long-term duration, which typically&#xD;
      lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term the&#xD;
      device training would be effective for treating sarcopenia. Therefore, the investigators&#xD;
      aimed to assess the effectiveness of Motor-Assisted and Active Resistive Upper/Lower&#xD;
      Extremities Rehabilitation Training System for treating sarcopenia in hospitalized older&#xD;
      patients aged 80 years and over.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of activities of daily living</measure>
    <time_frame>3 Months</time_frame>
    <description>Basic activities of daily living (BADL) assessed by Barthel Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of handgrip strength</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>controlled group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System</intervention_name>
    <description>The Passive, Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System is designed for patients conﬁned to bed at the long-term care facilities hospitals, in early rehabilitation. This system can induce a natural movements of the upper/lower limb with safe motorized passive movement, as well as motor-assisted and active resistive muscle training to stimulate nerves, increase blood circulation of aﬀected tissue, cell metabolism and improve joint mobility, in promoting upper/lower extremities motor recovery.</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)&#xD;
&#xD;
          -  Agree to participant this study and sign the informed consent&#xD;
&#xD;
          -  Aged 80 years or over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who could not follow the training plan due to cognitive impairment, emotional&#xD;
             problems or any other reasons;&#xD;
&#xD;
          -  Severe heart and lung diseases;&#xD;
&#xD;
          -  Renal insufficiency;&#xD;
&#xD;
          -  Any type of tumor;&#xD;
&#xD;
          -  Bedridden patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>80 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West China Hospital，Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610064</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuxiang Liang</last_name>
      <phone>0086-13982250862</phone>
      <email>yx45liang@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Yuxiang Liang</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</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/NCT04497480
org study id: 2020（001）
nct id: NCT04497480
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Most previous clinical trials that addressed the rehabilitation training system for
      sarcopenic elderly subjects focused on community-dwelling older adults who were relatively
      healthy. There is a notable paucity of high-quality research investigating the effects and
      feasibility of the device for hospitalized or institutionalized older people, who are
      generally frailer and more severe in functional impairment than those living in the
      community. Moreover, most reported the system were of long-term duration, which typically
      lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term the
      device training would be effective for treating sarcopenia. Therefore, the investigators
      aimed to assess the effectiveness of Motor-Assisted and Active Resistive Upper/Lower
      Extremities Rehabilitation Training System for treating sarcopenia in hospitalized older
      patients aged 80 years and over.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The change of activities of daily living
time frame: 3 Months
description: Basic activities of daily living (BADL) assessed by Barthel Index
measure: The change of handgrip strength
time frame: 3 months
arm group label: experimental group
arm group type: Experimental
arm group label: controlled group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System
description: The Passive, Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System is designed for patients conﬁned to bed at the long-term care facilities hospitals, in early rehabilitation. This system can induce a natural movements of the upper/lower limb with safe motorized passive movement, as well as motor-assisted and active resistive muscle training to stimulate nerves, increase blood circulation of aﬀected tissue, cell metabolism and improve joint mobility, in promoting upper/lower extremities motor recovery.
arm group label: experimental group
criteria: 
gender: All
minimum age: 80 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: West China Hospital
investigator full name: Yuxiang Liang
investigator title: Physiotherapist
mesh term: Sarcopenia