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Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Elderly.

Primary Purpose

Falls, Old Age; Debility, Hospitalisation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
elastic-band exercises
regular rehabilitation
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Falls

Eligibility Criteria

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

Inclusion Criteria:

  1. Elders are over 65 years old and admitted to this medical ward due to acute/chronic disease
  2. Elders have no physical impairment
  3. Elders have a clear cognition, can follow movement commands in Chinese or Taiwanese
  4. Elders have greater than 4 points in lower extremity muscle strength measured by the Manual Muscle Power Test
  5. Elders have greater than 45 points in the Morse Fall Scale, which indicate a high risk of falling

Exclusion Criteria:

  1. Unclear consciousness
  2. Unable to follow the execution of elastic band resistance training
  3. With restricted activities, musculoskeletal disorders, or nerve diseases
  4. Unsuitable athletic trainers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Elastic band

    Control

    Arm Description

    The experimental group received a 35-minute training course for 2 weeks, 3 times a week, each time during the hospitalization. A total of 4 assessments were performed: baseline (pre-intervention), after third-time intervention, post-intervention, and one week after the intervention.

    The control group was given routine rehabilitation exercise

    Outcomes

    Primary Outcome Measures

    Functional Fitness Test
    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.
    Functional Fitness Test
    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.
    Functional Fitness Test
    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.
    Tw-FROP-Com
    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.
    Tw-FROP-Com
    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.
    Tw-FROP-Com
    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2022
    Last Updated
    April 10, 2023
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05462015
    Brief Title
    Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Elderly.
    Official Title
    Effects of Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Old Adults With Hospitalized and High Fall Risk.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Recruitment difficulty in hospital caused by COVID-19
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    February 28, 2023 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University

    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
    A lack of studies has applied elastic band resistance training exercises on hospitalized elderly, so the effect of elastic band resistance training exercises on physical fitness and risk of falls was unclear. Therefore, the purposes of this study were to investigate the effectiveness of elastic band resistance training on improving physical fitness and reducing the risk of falls in hospitalized elderly with high risk of falls. This study is an experimental study. The experimental group was given 3 times a week for 2 consecutive weeks of elastic band resistance training, while the control group was given regular rehabilitation exercises. The differences in physical fitness and fall risk between the two groups were examined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Falls, Old Age; Debility, Hospitalisation, Resistance Training, Physical Fitness

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Elastic band
    Arm Type
    Experimental
    Arm Description
    The experimental group received a 35-minute training course for 2 weeks, 3 times a week, each time during the hospitalization. A total of 4 assessments were performed: baseline (pre-intervention), after third-time intervention, post-intervention, and one week after the intervention.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    The control group was given routine rehabilitation exercise
    Intervention Type
    Behavioral
    Intervention Name(s)
    elastic-band exercises
    Other Intervention Name(s)
    resistance band exercises
    Intervention Description
    The training content includes 5 minutes of warm-up exercise, 20 minutes of elastic-band resistance training, and 10 minutes of cool-down exercise.
    Intervention Type
    Behavioral
    Intervention Name(s)
    regular rehabilitation
    Intervention Description
    The training content includes 5-minute warm-up exercise, 20-minute upper and lower extremity muscle strengthening, and 10-minute cool-down exercise
    Primary Outcome Measure Information:
    Title
    Functional Fitness Test
    Description
    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.
    Time Frame
    first day
    Title
    Functional Fitness Test
    Description
    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.
    Time Frame
    one week
    Title
    Functional Fitness Test
    Description
    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.
    Time Frame
    completed through training, usually two weeks
    Title
    Tw-FROP-Com
    Description
    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.
    Time Frame
    first day
    Title
    Tw-FROP-Com
    Description
    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.
    Time Frame
    completed through training, usually two weeks
    Title
    Tw-FROP-Com
    Description
    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.
    Time Frame
    one week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elders are over 65 years old and admitted to this medical ward due to acute/chronic disease Elders have no physical impairment Elders have a clear cognition, can follow movement commands in Chinese or Taiwanese Elders have greater than 4 points in lower extremity muscle strength measured by the Manual Muscle Power Test Elders have greater than 45 points in the Morse Fall Scale, which indicate a high risk of falling Exclusion Criteria: Unclear consciousness Unable to follow the execution of elastic band resistance training With restricted activities, musculoskeletal disorders, or nerve diseases Unsuitable athletic trainers

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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