NCT06205147

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 5, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 24, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

October 24, 2023

Last Update Submit

July 21, 2025

Conditions

Keywords

resistance exercisehospitalized elderlymuscle strengthdepressionFunctional decline

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Short Falls Efficacy Scale International Short FES

    20 minutes

Other Outcomes (1)

  • Geriatric Depression Scale, GDS 15.

    20 minutes

Study Arms (2)

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.

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.

Device: Elastic Band

Interventions

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 15Short Falls Efficacy Scale International

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing of National Taiwan University

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Muscle WeaknessDepression

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBehavioral SymptomsBehavior

Central Study Contacts

PIAO-YI CHIOU, doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Random control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2023

First Posted

January 12, 2024

Study Start

March 5, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 24, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations