Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly.

NCT ID: NCT06205147

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Resistance Exercise; Muscle Weakness; Functional Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Short Falls Efficacy Scale International

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.

Group Type: EXPERIMENTAL

Elastic Band

Intervention Type: DEVICE

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.

Geriatric Depression Scale, GDS 15

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.

Group Type: EXPERIMENTAL

Elastic Band

Intervention Type: DEVICE

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.

Interventions

Elastic Band

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age of 65 years or older.

2. Anticipated hospital stay exceeding 7 days.

3. Able to follow instructions.

4. 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.

Exclusion Criteria

1. 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.

2. Poorly controlled hypertension, with systolic blood pressure less than 90 mmHg or greater than 200 mmHg under medication.

3. Individuals hospitalized due to acute neurological injuries or conditions, such as epilepsy, stroke, or Parkinson's disease.

4. Diagnosed with cognitive impairment or Alzheimer's disease.

5. Those who require long-term ventilator support and are unable to participate in the program.

6. Individuals with impaired consciousness who cannot cooperate.

7. A Glasgow Coma Scale score of less than 12, or inability to correctly answer questions about person, time, place, or follow instructions.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University

OTHER

Sponsor Role: lead

Responsible Party

Piao-Yi Chiou

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Nursing of National Taiwan University

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

PIAO-YI CHIOU, doctoral

Role: CONTACT

piaoyi@ntu.edu.tw

+886-2-23123456 ext. 88427

Facility Contacts

PIAO-YI CHIOU, doctoral

Role: primary

piaoyi@ntu.edu.tw

+886-2-23123456 ext. 88427

Other Identifiers

202306142RIND

Identifier Type: -

Identifier Source: org_study_id