Resistance ExerciseNCT06205147
Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly.
A study testing Elastic Band in people with Resistance Exercise and Muscle Weakness, run by National Taiwan University at 1 site in Taiwan.
Trial summary
With improved a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals. This study is a random control trial. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Resistance Exercise, Muscle Weakness, Functional Decline
- What is being tested?
- Elastic Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age of 65 years or older.
- Anticipated hospital stay exceeding 7 days.
- Able to follow instructions.
- Four-limb muscle strength of at least three points, and grip strength measurements with a minimum of 26 kilograms for males and 18 kilograms for females.
Who cannot join
- This includes individuals with cardiovascular diseases such as acute myocardial infarction, unstable angina, poorly controlled arrhythmias, complete atrioventricular block, acute heart failure, acute myocarditis, acute pericarditis, and other cardiac conditions.
- Poorly controlled hypertension, with systolic blood pressure less than 90 mmHg or greater than 200 mmHg under medication.
- Individuals hospitalized due to acute neurological injuries or conditions, such as epilepsy, stroke, or Parkinson's disease.
- Diagnosed with cognitive impairment or Alzheimer's disease.
- Those who require long-term ventilator support and are unable to participate in the program.
- Individuals with impaired consciousness who cannot cooperate.
- A Glasgow Coma Scale score of less than 12, or inability to correctly answer questions about person, time, place, or follow instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
School of Nursing of National Taiwan University
Taipei, Taiwan, 100
PIAO-YI CHIOU, doctoral, +886-2-23123456 ext. 88427, piaoyi@ntu.edu.tw
About this study
Official title: Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly Patients.
With improved a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals. This study is a random control trial. Data collection includes elderly patient's total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized. The total muscle mass and upper and lower extremity muscle strength will be calculated in kilograms.
Read the detailed description
Investigators have designed a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals.
Investigators will enroll individuals aged 65 hospitalized elderly. participants will be randomly assigned to either the experimental or control group. The experimental group will undergo a five-day resistance exercise program using elastic bands, with two 20-minute sessions per day (totaling 200 minutes). The program aims to improve muscle mass and strength. Non-invasive instruments will be used to measure muscle mass and strength, and participants will complete self-report questionnaires on fear of fall and geriatric depression.
- Conditions
- Resistance Exercise, Muscle Weakness, Functional Decline
- Being tested
- Elastic Band
- Keywords
- resistance exercise, hospitalized elderly, muscle strength, depression, Functional decline
- Medical subject headings
- Muscle Weakness, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic BandDevice
Using the newly patented product, the Muscle Exercise and Falling Prevention Elastic Strap (Patent Certificate No. M585601), the procedure involves securing the elastic strap to a high-back chair to administer elastic band intervention exercises for patients.Guided by continuous contextual action demonstration videos, participants will engage in the elastic band resistance intervention twice a day, each session lasting 20 minutes, over a span of five days. These videos are designed to provide a continuous contextual demonstration, incorporating them within the video itself.
| Study group | Role | What they receive |
|---|---|---|
| Short Falls Efficacy Scale International | Experimental | The Short Falls Efficacy Scale International (Short FES-I) consists of 7 questions. Scores range from a minimum of 7 points (no fear of falling) to a maximum of 28 points (severe fear of falling). Scores of 7 to 8 points indicate low concern about falling, 9 to 13 points indicate moderate concern about falling, and 14 to 28 points indicate high concern about falling. Receives: Device: Elastic Band |
| Geriatric Depression Scale, GDS 15 | Experimental | The assessment will be conducted within one week. Depressive symptoms in the elderly will be evaluated using a binary method, with answers of "yes" or "no." Questions 1, 5, 7, 11, and 13 should be answered with "no." Questions 2, 3, 4, 6, 8, 9, 10, 12, 14, and 15 should be answered with "yes." Each "yes" response is assigned 1 point, resulting in a total score of 15 points. Scores ranging from 0 to 6 indicate good emotional adjustment, scores from 7 to 10 indicate moderate emotional distress, and scores above 11 indicate severe emotional distress. Receives: Device: Elastic Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
total muscle mass and upper and lower extremity muscle strength
The changes in muscle mass and muscle strength will be measured before and after the intervention,The total muscle mass and upper and lower extremity muscle strength will be calculated in kilograms.
Measured: 20 minutes
Secondary outcomes (1)
Short Falls Efficacy Scale International Short FES
We will use the scale to measure changes in concerns about falling before and after the intervention.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start5 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance ExerciseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piao-Yi Chiou, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205147
- Sponsor's protocol ID
- 202306142RIND
- Status last verified
- May 2025
- First submitted
- 24 Oct 2023
- Last updated
- 24 Jul 2025
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly Patients.
- ClinicalTrials.gov ID
- NCT06205147
- Acronym / sponsor ID
- 202306142RIND
- Conditions
- Resistance Exercise, Muscle Weakness, Functional Decline
- Keywords
- resistance exercise, hospitalized elderly, muscle strength, depression, Functional decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jan 2024 (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.
With improved a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals. This study is a random control trial. Data collection includes elderly patient's total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized. The total muscle mass and upper and lower extremity muscle strength will be calculated in kilograms.
Detailed description
Investigators have designed a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals.
Investigators will enroll individuals aged 65 hospitalized elderly. participants will be randomly assigned to either the experimental or control group. The experimental group will undergo a five-day resistance exercise program using elastic bands, with two 20-minute sessions per day (totaling 200 minutes). The program aims to improve muscle mass and strength. Non-invasive instruments will be used to measure muscle mass and strength, and participants will complete self-report questionnaires on fear of fall and geriatric depression.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Random control trial
| Arm | Type | Receives |
|---|---|---|
| Short Falls Efficacy Scale International | Experimental | Device: Elastic BandThe Short Falls Efficacy Scale International (Short FES-I) consists of 7 questions. Scores range from a minimum of 7 points (no fear of falling) to a maximum of 28 points (severe fear of falling). Scores of 7 to 8 points indicate low concern about falling, 9 to 13 points indicate moderate concern about falling, and 14 to 28 points indicate high concern about falling. |
| Geriatric Depression Scale, GDS 15 | Experimental | Device: Elastic BandThe assessment will be conducted within one week. Depressive symptoms in the elderly will be evaluated using a binary method, with answers of "yes" or "no." Questions 1, 5, 7, 11, and 13 should be answered with "no." Questions 2, 3, 4, 6, 8, 9, 10, 12, 14, and 15 should be answered with "yes." Each "yes" response is assigned 1 point, resulting in a total score of 15 points. Scores ranging from 0 to 6 indicate good emotional adjustment, scores from 7 to 10 indicate moderate emotional distress, and scores above 11 indicate severe emotional distress. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age of 65 years or older.
- Anticipated hospital stay exceeding 7 days.
- Able to follow instructions.
- Four-limb muscle strength of at least three points, and grip strength measurements with a minimum of 26 kilograms for males and 18 kilograms for females.
Key exclusion criteria (7 listed)
- This includes individuals with cardiovascular diseases such as acute myocardial infarction, unstable angina, poorly controlled arrhythmias, complete atrioventricular block, acute heart failure, acute myocarditis, acute pericarditis, and other cardiac conditions.
- Poorly controlled hypertension, with systolic blood pressure less than 90 mmHg or greater than 200 mmHg under medication.
- Individuals hospitalized due to acute neurological injuries or conditions, such as epilepsy, stroke, or Parkinson's disease.
- Diagnosed with cognitive impairment or Alzheimer's disease.
- Those who require long-term ventilator support and are unable to participate in the program.
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 BandUsing the newly patented product, the Muscle Exercise and Falling Prevention Elastic Strap (Patent Certificate No. M585601), the procedure involves securing the elastic strap to a high-back chair to administer elastic band intervention exercises for patients.Guided by continuous contextual action demonstration videos, participants will engage in the elastic band resistance intervention twice a day, each session lasting 20 minutes, over a span of five days. These videos are designed to provide a continuous contextual demonstration, incorporating them within the video itself. | Device | Geriatric Depression Scale, GDS 15, Short Falls Efficacy Scale International |
Primary outcome
total muscle mass and upper and lower extremity muscle strength
Time frame: 20 minutes
The changes in muscle mass and muscle strength will be measured before and after the intervention,The total muscle mass and upper and lower extremity muscle strength will be calculated in kilograms.
1 secondary outcome
Short Falls Efficacy Scale International Short FES
Time frame: 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Band in people with Resistance Exercise and Muscle Weakness, run by National Taiwan University at 1 site in Taiwan.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PIAO-YI CHIOU, doctoral (+886-2-23123456 ext. 88427, piaoyi@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total muscle mass and upper and lower extremity muscle strength (time frame: 20 minutes). 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 24 Jul 2025.