FallsNCT05462015
Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Elderly.
A study testing elastic-band exercises and regular rehabilitation in people with Falls and Old Age; Debility, run by Taipei Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls, Old Age; Debility, Hospitalisation
- What is being tested?
- elastic-band exercises and regular rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Unclear consciousness
- Unable to follow the execution of elastic band resistance training
- With restricted activities, musculoskeletal disorders, or nerve diseases
- Unsuitable athletic trainers
About this study
Official title: Effects of Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Old Adults With Hospitalized and High Fall Risk.
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.
- Conditions
- Falls, Old Age; Debility, Hospitalisation, Resistance Training, Physical Fitness
- Being tested
- elastic-band exercises, regular rehabilitation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastic-band exercisesBehavioural
Also called resistance band exercises
The training content includes 5 minutes of warm-up exercise, 20 minutes of elastic-band resistance training, and 10 minutes of cool-down exercise.
regular rehabilitationBehavioural
The training content includes 5-minute warm-up exercise, 20-minute upper and lower extremity muscle strengthening, and 10-minute cool-down exercise
| Study group | Role | What they receive |
|---|---|---|
| Elastic band | Experimental | 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. Receives: Behavioral: elastic-band exercises |
| Control | Active comparator | The control group was given routine rehabilitation exercise Receives: Behavioral: regular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first day
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.
Measured: one week
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.
Measured: completed through training, usually two weeks
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.
Measured: first day
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.
Measured: completed through training, usually two weeks
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Why it stopped: Recruitment difficulty in hospital caused by COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gong-Hong Lin, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462015
- Sponsor's protocol ID
- N202205064
- Status last verified
- Apr 2023
- First submitted
- 11 Jul 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Old Adults With Hospitalized and High Fall Risk.
- ClinicalTrials.gov ID
- NCT05462015
- Acronym / sponsor ID
- N202205064
- Conditions
- Falls, Old Age; Debility, Hospitalisation, Resistance Training, Physical Fitness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulty in hospital caused by COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic band | Experimental | Behavioral: elastic-band exercisesThe 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. |
| Control | Active comparator | Behavioral: regular rehabilitationThe control group was given routine rehabilitation exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Unclear consciousness
- Unable to follow the execution of elastic band resistance training
- With restricted activities, musculoskeletal disorders, or nerve diseases
- Unsuitable athletic trainers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elastic-band exercisesAlso: resistance band exercisesThe training content includes 5 minutes of warm-up exercise, 20 minutes of elastic-band resistance training, and 10 minutes of cool-down exercise. | Behavioural | Elastic band |
| regular rehabilitationThe training content includes 5-minute warm-up exercise, 20-minute upper and lower extremity muscle strengthening, and 10-minute cool-down exercise | Behavioural | Control |
Primary outcome
Functional Fitness Test
Time frame: first day
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
Time frame: one week
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
Time frame: completed through training, usually two weeks
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
Time frame: first day
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
Time frame: completed through training, usually two weeks
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
Time frame: one week
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing elastic-band exercises and regular rehabilitation in people with Falls and Old Age; Debility, run by Taipei Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Fitness Test (time frame: first day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.