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

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06205147
• Other study ID #: 202306142RIND
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: National Taiwan University
• Contact: PIAO-YI CHIOU, doctoral
• Phone: +886-2-23123456
• Email: piaoyi[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Functional Decline
• Muscle Weakness
• Resistance Exercise

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	School of Nursing of National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geriatric Depression Scale, GDS 15.	The Geriatric Depression Scale (GDS-15) will be employed to measure changes in depressive symptoms among the elderly before and after the intervention.	20 minutes
Primary	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.	20 minutes
Secondary	Short Falls Efficacy Scale International Short FES	We will use the scale to measure changes in concerns about falling before and after the intervention.	20 minutes