Clinical trial NCT06901700: Effects of Home-based Lower Extremity Muscle Power Training on Functional Muscle and Balance Performance in Older Adults
Official title: Effects of Home-based Lower Extremity Muscle Power Training on Functional Muscle and Balance Performance in Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Adults
Keywords: Power training
Home-based training
Muscle performance
Balance
Older adults
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 adjusted every two weeks to gradually increase the challenge of the exercises. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional muscle performance-muscle power
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Functional muscle performance-muscle strength
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Balance
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Timed Up and Go Test
timeFrame: From baseline to the end of treatment at 8 weeks
Secondary outcomes:
measure: Fall confidence
timeFrame: From baseline to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ray-Yau Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: