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Effect of Technology-assisted Physical Therapy for Patient With High Risk of Sarcopenia (HRS)

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
elastic band resisted exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age above 65 years old MMSE > 24 points walking more than 6 meters independently Exclusion Criteria: people who cannot participate for 3 -day exercise for each week

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Video-assisted group

    Traditional group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Grip strength
    use hand dynamometer to test maximal strength
    walking speed
    walk for 4 meters to test the time that participant used
    Timed up-and-go test

    Secondary Outcome Measures

    Short Physical Performance Battery (SPPB)

    Full Information

    First Posted
    January 8, 2023
    Last Updated
    January 8, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05687630
    Brief Title
    Effect of Technology-assisted Physical Therapy for Patient With High Risk of Sarcopenia
    Acronym
    HRS
    Official Title
    Effect of Technology-assisted Physical Therapy for Patient With High Risk of Sarcopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    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
    This research aims to identify whether the effects of video-assisted physical therapy, including home resistance training, is superior to traditional physical therapy, education leaflet for example. This is an interventional research, single-blind, randomized control trail. We recruit high risk of sarcopenia people (low muscle strength and low physical performance) Two groups of participants are divided into traditional group and video-assisted group, both group are taught the same resisted exercise by physical therapist.
    Detailed Description
    Both group will record his/her baseline activity level with a given pedometer. After one week recording, we started initial evaluation (history taking, physical examination) and intervention. Participants are taught thera-band resisted exercise, including large musculature of upper and lower extremities, each exercise are conducted 10-15 times for 3 sets. Traditional group will receive an education leaflet and a notebook to record his/ her daily activity and frequency of exercise to record the compliance. Video-assisted group will receive a QR code, which contain a website of exercise video on the cloud. After 3 months intervention, participant will come back to our center for final examination.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Video-assisted group
    Arm Type
    Experimental
    Arm Title
    Traditional group
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    elastic band resisted exercise
    Other Intervention Name(s)
    resisted exercise
    Intervention Description
    muscle strengthening exercise, 10-15 times of each set, for 3 sets
    Primary Outcome Measure Information:
    Title
    Grip strength
    Description
    use hand dynamometer to test maximal strength
    Time Frame
    three months after initial evaluation
    Title
    walking speed
    Description
    walk for 4 meters to test the time that participant used
    Time Frame
    three months after initial evaluation
    Title
    Timed up-and-go test
    Time Frame
    three months after initial evaluation
    Secondary Outcome Measure Information:
    Title
    Short Physical Performance Battery (SPPB)
    Time Frame
    three months after initial evaluation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age above 65 years old MMSE > 24 points walking more than 6 meters independently Exclusion Criteria: people who cannot participate for 3 -day exercise for each week
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chen Yu Kuo, Bachelor
    Phone
    +886 988581069
    Email
    119271@ntuh.gov.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chen Yu Kuo, Bachelor
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Technology-assisted Physical Therapy for Patient With High Risk of Sarcopenia

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