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Early Detection of Disability and Health Promotion for Community-dwelling Elderly

Primary Purpose

Elderly, Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise training
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elderly focused on measuring early detection, health promotion, community-dwelling, elderly

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age greater than 50 years
  • able to follow simple instructions
  • willing to participate and sign consent form

Exclusion Criteria:

  • unstable angina or epilepsy
  • severe visual deficits
  • cognitive dysfunction
  • other musculoskeletal conditions that will limit mobility

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    exercise training

    control

    Arm Description

    Participants in the exercise training group received a 12-week exercise training.

    Participants in the control group did not receive any specific training programs instead of maintaining their usual activities of daily living.

    Outcomes

    Primary Outcome Measures

    Walking speed
    Participants are asked to walk along a 14 m hallway. The time taken to the middle 10 m is recorded to calculate walking speed (m/s).
    Muscle strength
    Muscle strength is assessed using hand-hold Dynamometers

    Secondary Outcome Measures

    Timed up and go test
    Participants are asked to stand up, walk 3 m, turn around a cone, and return to a sitting position
    Walking endurance
    Participants are asked to walk back and forth along a 20-meter corridor and to cover the maximum distance possible in six minutes
    Sit-to-stand test
    Participants are asked to stand up and sit down 5 times.
    Berg balance scale
    It consists of 14 items, including sitting unsupported, standing unsupported, standing with eyes closed, standing with feet together, standing on one foot, turning to look behind, retrieving objective from floor, random standing, reaching forward with an outsrptretched arm, sit to stand, stand to sit, transfer, turning 360 degrees, stool stepping, scored from 0 to 4, "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56.
    Gait kinematics
    Gait kinematics are assessed by angular displacement of lower limbs using shoe-worn inertial measurement unit based device

    Full Information

    First Posted
    July 5, 2018
    Last Updated
    July 23, 2018
    Sponsor
    Buddhist Tzu Chi General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03607136
    Brief Title
    Early Detection of Disability and Health Promotion for Community-dwelling Elderly
    Official Title
    Department of Physical Therapy, Tzu Chi University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2018 (Anticipated)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Buddhist Tzu Chi General Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. Half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living.
    Detailed Description
    Physical inactivity can result in physical frailty and sarcopenia. Physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality. Regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. Nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. One of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Elderly, Sarcopenia
    Keywords
    early detection, health promotion, community-dwelling, elderly

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    exercise training
    Arm Type
    Experimental
    Arm Description
    Participants in the exercise training group received a 12-week exercise training.
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    Participants in the control group did not receive any specific training programs instead of maintaining their usual activities of daily living.
    Intervention Type
    Other
    Intervention Name(s)
    exercise training
    Intervention Description
    Aerobic exercises, strengthening exercises, flexibility training for 60min, twice a week for 12 weeks
    Primary Outcome Measure Information:
    Title
    Walking speed
    Description
    Participants are asked to walk along a 14 m hallway. The time taken to the middle 10 m is recorded to calculate walking speed (m/s).
    Time Frame
    Change from baseline at 12 weeks
    Title
    Muscle strength
    Description
    Muscle strength is assessed using hand-hold Dynamometers
    Time Frame
    Change from baseline at 12 weeks
    Secondary Outcome Measure Information:
    Title
    Timed up and go test
    Description
    Participants are asked to stand up, walk 3 m, turn around a cone, and return to a sitting position
    Time Frame
    Change from baseline at 12 weeks
    Title
    Walking endurance
    Description
    Participants are asked to walk back and forth along a 20-meter corridor and to cover the maximum distance possible in six minutes
    Time Frame
    Change from baseline at 12 weeks
    Title
    Sit-to-stand test
    Description
    Participants are asked to stand up and sit down 5 times.
    Time Frame
    Change from baseline at 12 weeks
    Title
    Berg balance scale
    Description
    It consists of 14 items, including sitting unsupported, standing unsupported, standing with eyes closed, standing with feet together, standing on one foot, turning to look behind, retrieving objective from floor, random standing, reaching forward with an outsrptretched arm, sit to stand, stand to sit, transfer, turning 360 degrees, stool stepping, scored from 0 to 4, "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56.
    Time Frame
    Change from baseline at 12 weeks
    Title
    Gait kinematics
    Description
    Gait kinematics are assessed by angular displacement of lower limbs using shoe-worn inertial measurement unit based device
    Time Frame
    Change from baseline at 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age greater than 50 years able to follow simple instructions willing to participate and sign consent form Exclusion Criteria: unstable angina or epilepsy severe visual deficits cognitive dysfunction other musculoskeletal conditions that will limit mobility

    12. IPD Sharing Statement

    Learn more about this trial

    Early Detection of Disability and Health Promotion for Community-dwelling Elderly

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