- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06901700
Effects of Home-based Lower Extremity Muscle Power Training on Functional Muscle and Balance Performance in Older Adults
Background: Muscle power, defined as the rate at which muscular force is generated to produce movement, declines more rapidly with age than muscle strength. The decline in lower extremity muscle power is associated with reduced functional independence, impaired mobility, and an increased risk of falls among older adults. While power training has been shown to improve muscle power, balance, and functional abilities, the feasibility and effectiveness of home-based interventions have not been thoroughly investigated.
Purpose: The aim of this study is to investigate the effects of home-based lower extremity muscle power training program on functional muscle and balance performance in older adults.
Methods: This is a single-blind, randomized controlled trial. Forty community-dwelling older adults will be recruited and randomly assigned to the experimental group (n=20) and control group (n=20). Participants in the experimental group will complete 24 sessions of home-based lower extremity muscle power training targeting the lower limb muscle groups in 8 weeks. The training intensity will be progressively adjusted according to participants' performance. Participants in the control group will maintain their daily activities. In addition, both groups will receive health education. Primary outcomes include functional muscle power measured by the Four-Step Stair Climb Power Test, functional muscle strength measured by Five Times Sit-to-Stand Test, and the functional balance performance measured by the Mini-BESTest, and Timed Up and Go Test. The fall confidence, as the secondary outcome, will be measured by Falls Efficacy Scale International.
Statistical analysis: The SPSS® version 29 will be used for statistical analysis. Independent-t-test or chi-square test will be conducted to compare the baseline demographic characteristics between groups. Two-way repeated measure ANOVA will be used to compare the differences between groups and times, post-hoc analyses will be performed using Tukey's test. The significance level is set at 0.05.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ray-Yau Wang, PhD
- Phone Number: +88628267210
- Email: rywang@nycu.edu.tw
Study Locations
-
-
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Taipei, Taiwan, 112
- Recruiting
- National Yang Ming Chiao Tung University
-
Contact:
- Ray-Yau Wang, PhD
- Phone Number: +886-2-28267210
- Email: rywang@nycu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 65~80 years old community-dwelling adults
- MMSE≥24
- Use smart phone routinely
Exclusion Criteria:
- Recent (<1 year) musculoskeletal injury or disability in the lower limbs
- Unstable cardiovascular, neurological disease, or metabolic disease interfering with participating in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group
Health education
|
Health education
|
|
Experimental: Experimental group
Total 40~60 minutes, 3 sessions per week in alternate day for 8 weeks, total 24 sessions
|
Total 40~60 minutes, 3 sessions per week in alternate day for 8 weeks, total 24 sessions 5 min warm up and 5 min cool down Power training (using body weight as resistance): hip flexor, hip extensor, hip adductor, hip abductor, knee flexor, ankle plantarflexor, hip external rotator, hip internal rotator, knee extensor, ankle dorsiflexor, ankle invertor, ankle evertor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional muscle performance-muscle power
Time Frame: From baseline to the end of treatment at 8 weeks
|
The Four-Step Stair Climb Power Test is used for measurement, where participants rapidly ascend four steps while the required time is recorded.
This test is designed to assess lower limb muscle power.
|
From baseline to the end of treatment at 8 weeks
|
|
Functional muscle performance-muscle strength
Time Frame: From baseline to the end of treatment at 8 weeks
|
The 5 Times Sit-to-Stand Test is used for measurement, where participants quickly and continuously perform five sit-to-stand movements while the required time is recorded.
This test is designed to assess lower limb muscle strength.
|
From baseline to the end of treatment at 8 weeks
|
|
Balance
Time Frame: From baseline to the end of treatment at 8 weeks
|
The Mini-BESTest (Balance Evaluation Systems Test) is used for measurement.
This test includes anticipatory control, reactive postural control, sensory orientation, and dynamic gait, allowing for the assessment of balance abilities related to postural control.
|
From baseline to the end of treatment at 8 weeks
|
|
Timed Up and Go Test
Time Frame: From baseline to the end of treatment at 8 weeks
|
The Timed Up and Go (TUG) Test is conducted at both a normal and fast pace to assess the balance and mobility of community-dwelling older adults in functional activities.
|
From baseline to the end of treatment at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fall confidence
Time Frame: From baseline to the end of treatment at 8 weeks
|
The Falls Efficacy Scale International (FES-I) is used for assessment.
This scale evaluates the level of confidence in not falling while performing activities of daily living.
|
From baseline to the end of treatment at 8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ray-Yau Wang, PhD, National Yang Ming Chiao Tung University
Study record dates
Study Major Dates
Study Start (Actual)
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NYCU114046AF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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