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Withdrawn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
About this trial
This is an interventional treatment trial for Falls
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
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
NCT ID
NCT05462015
First Posted
July 11, 2022
Last Updated
April 10, 2023
Sponsor
Taipei Medical University
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
Learn more about this trial
Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Elderly.
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