- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06205147
Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly.
Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly Patients.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: PIAO-YI CHIOU, doctoral
- Phone Number: 88427 +886-2-23123456
- Email: piaoyi@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- School of Nursing of National Taiwan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Falls Efficacy Scale International Short FES
Time Frame: 20 minutes
|
We will use the scale to measure changes in concerns about falling before and after the intervention.
|
20 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geriatric Depression Scale, GDS 15.
Time Frame: 20 minutes
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202306142RIND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscle Weakness
-
St. Luke's-Roosevelt Hospital CenterCompletedFall Risk | Quadriceps Muscle Weakness | Adductor Muscle WeaknessUnited States
-
Association Pro-arteActive, not recruitingWeakness, Muscle | AmyotrophiaFrance
-
University of Central ArkansasCompletedPelvic Floor Muscle WeaknessUnited States
-
Ludwig Boltzmann Institute of Electrical Stimulation...Medical University of Vienna; European Union; Comenius University; Ministry of...CompletedMuscle Weakness Condition | Therapy EffectAustria, Slovakia
-
Rutgers, The State University of New JerseyRecruitingPhysical Disability | Muscle Atrophy or Weakness | Muscle Loss | Physical Inactivity | Delirium in Old Age | Hospital Acquired Condition | Weakness, MuscleUnited States
-
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie...RecruitingMuscle Weakness | Muscle Weakness Condition | CopdRomania
-
University of MilanCompleted
-
University of Texas Southwestern Medical CenterTerminatedMuscle Cramp | Statin Adverse Reaction | Weakness, Muscle | AcheUnited States
-
University of Central FloridaCompletedMuscle Weakness | Muscle Atrophy | Muscle Loss | Weakness, Muscle | Injury, KneeUnited States
-
Riphah International UniversityCompletedMuscle Weakness ConditionPakistan
Clinical Trials on Elastic Band
-
National Taiwan University HospitalChina Medical University, TaiwanCompletedMigraine; StatusTaiwan
-
Riphah International UniversityCompleted
-
Universidade Estadual de LondrinaUnknown
-
São Paulo State UniversityCoordination for the Improvement of Higher Education PersonnelCompleted
-
Aalborg University HospitalUniversity of Copenhagen; Hvidovre University Hospital; Amager Hospital; Aalborg...Completed
-
Chang Bing Show Chwan Memorial HospitalUnknown
-
University of West AtticaNot yet recruiting
-
Lou QingqingCompleted
-
Taipei Medical UniversityWithdrawnOld Age; Debility | Falls | Resistance Training | Physical Fitness | Hospitalisation
-
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical...CompletedBody Weight Changes | Sarcopenia | Prader Labhart Willi SyndromeTaiwan