NCT06901700

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 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 16, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 5, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

March 24, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

Power trainingHome-based trainingMuscle performanceBalanceOlder adults

Outcome Measures

Primary Outcomes (4)

  • Functional muscle performance-muscle power

    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

    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

    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

    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 Outcomes (1)

  • Fall confidence

    From baseline to the end of treatment at 8 weeks

Study Arms (2)

Control group

OTHER

Health education

Other: control group

Experimental group

EXPERIMENTAL

Total 40\~60 minutes, 3 sessions per week in alternate day for 8 weeks, total 24 sessions

Other: Experimental Group

Interventions

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

Experimental group

Health education

Control group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • \~80 years old community-dwelling adults
  • MMSE≥24
  • Use smart phone routinely

You may not qualify if:

  • Recent (\<1 year) musculoskeletal injury or disability in the lower limbs
  • Unstable cardiovascular, neurological disease, or metabolic disease interfering with participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ray-Yau Wang, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray-Yau Wang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

July 16, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

September 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations