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A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
balance training
resistance training
aerobic exercise
usual care
Sponsored by
Yuxiang Liang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

80 Years - 102 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. aged ≥80 years;
  2. being able to ambulate (assistance was acceptable);
  3. being able to communicate and collaborate with the physiotherapist;
  4. with sarcopenia defined by the AWGS criteria ;

Exclusion Criteria:

  1. terminal illness;
  2. uncontrolled heart failure;
  3. myocardial infarction within the past three months;
  4. uncontrolled respiratory failure;
  5. bone fractures within the past three months;
  6. acute pulmonary embolism;
  7. major surgery within the past three months;
  8. uncontrolled arrhythmia;
  9. refusal to participate in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intervention group

    control group

    Arm Description

    a mixed exercise program including aerobic, balance, and resistance exercises that were personally tailored.

    usual care

    Outcomes

    Primary Outcome Measures

    The change of activities of daily living from the baseline to the end of the 2-week intervention
    Basic activities of daily living (BADL) assessed by Barthel Index. The total score for Barthel Index ranges from 0 (worst) to 100 (best) points.

    Secondary Outcome Measures

    The change of gait speed
    Gait speed was measured using a 4-meter walking test.
    The change of handgrip strength
    Handgrip strength was measured using a digital grip dynamometer
    The change of the score of Short Physical Performance Battery
    The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The total score for SPPB ranges from 0 (worst) to 12 (best) points.
    The change of the score of Timed Up and Go test
    The Timed Up and Go test (TUG) is a simple test used to measure basic functional mobility and safety with mobility. The score for the TUG is the time consumption of the whole process. The longer time consuption indicates the more worse outcome.

    Full Information

    First Posted
    April 17, 2020
    Last Updated
    April 20, 2020
    Sponsor
    Yuxiang Liang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04355299
    Brief Title
    A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years
    Official Title
    Effectiveness of a Short-term Mixed Exercise Program for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    December 30, 2019 (Actual)
    Study Completion Date
    January 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yuxiang Liang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Most previous clinical trials that addressed exercise 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 exercise 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 exercise programs were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term exercise would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of short-term exercise for treating sarcopenia in hospitalized older patients aged 80 years and over.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    121 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    a mixed exercise program including aerobic, balance, and resistance exercises that were personally tailored.
    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    balance training
    Intervention Description
    The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.
    Intervention Type
    Behavioral
    Intervention Name(s)
    resistance training
    Intervention Description
    Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells.
    Intervention Type
    Behavioral
    Intervention Name(s)
    aerobic exercise
    Intervention Description
    Aerobic exercise is any activity that gets your blood pumping and large muscle groups working. It's also known as cardiovascular activity.
    Intervention Type
    Behavioral
    Intervention Name(s)
    usual care
    Intervention Description
    received usual care
    Primary Outcome Measure Information:
    Title
    The change of activities of daily living from the baseline to the end of the 2-week intervention
    Description
    Basic activities of daily living (BADL) assessed by Barthel Index. The total score for Barthel Index ranges from 0 (worst) to 100 (best) points.
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    The change of gait speed
    Description
    Gait speed was measured using a 4-meter walking test.
    Time Frame
    2 weeks
    Title
    The change of handgrip strength
    Description
    Handgrip strength was measured using a digital grip dynamometer
    Time Frame
    2 weeks
    Title
    The change of the score of Short Physical Performance Battery
    Description
    The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The total score for SPPB ranges from 0 (worst) to 12 (best) points.
    Time Frame
    2 weeks
    Title
    The change of the score of Timed Up and Go test
    Description
    The Timed Up and Go test (TUG) is a simple test used to measure basic functional mobility and safety with mobility. The score for the TUG is the time consumption of the whole process. The longer time consuption indicates the more worse outcome.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    80 Years
    Maximum Age & Unit of Time
    102 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged ≥80 years; being able to ambulate (assistance was acceptable); being able to communicate and collaborate with the physiotherapist; with sarcopenia defined by the AWGS criteria ; Exclusion Criteria: terminal illness; uncontrolled heart failure; myocardial infarction within the past three months; uncontrolled respiratory failure; bone fractures within the past three months; acute pulmonary embolism; major surgery within the past three months; uncontrolled arrhythmia; refusal to participate in this study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiaojiao Jiang
    Organizational Affiliation
    West China Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ming Yang
    Organizational Affiliation
    West China Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years

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