NCT06714175

Brief Summary

This study investigates the effects of lower limb leg press power training combined with visual feedback games on the physical performance, cognitive function, and heart rate variability (HRV) of older adults aged 65 and above. Participants were divided into an experimental group and a control group, with the experimental group engaging in leg press exercises combined with visual games twice a week for 12 weeks.

Trial Health

55
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 Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

September 18, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 13, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

ElderlyMuscle StrengthLower Limb Power TrainingVisual Feedback GamesCognitive FunctionHeart Rate VariabilityResistance Training

Outcome Measures

Primary Outcomes (2)

  • Muscle Strength

    Measurement of lower limb muscle strength (pound), including the quadriceps and hamstrings

    Testing will be conducted in Week 0, Week 6, and Week 13

  • Muscle Strength

    hand grip strength (kilogram)

    Testing will be conducted in Week 0, Week 6, and Week 13

Secondary Outcomes (17)

  • Physiological Data

    Testing will be conducted in Week 0, Week 6, and Week 13.

  • Physiological Data

    Testing will be conducted in Week 0, Week 6, and Week 13

  • Physiological Data

    Testing will be conducted in Week 0, Week 6, and Week 13

  • Physiological Data

    Testing will be conducted in Week 0, Week 6, and Week 13

  • Heart Rate Variability (HRV)

    Baseline measurement at Week 0 and follow-up measurement at Week 13.

  • +12 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

This group will not receive any specific muscle power intervention.

Lower Limb Strength Training Program with Visual Feedback

EXPERIMENTAL

This lower limb explosive strength training system integrates visual feedback games and is equipped with angle and force sensors to simultaneously output the power of the left and right legs, as well as maximum explosive force and pushing force. Users can immediately understand the balance of leg strength and make adjustments, making it particularly suitable for the elderly to improve lower limb strength or for rehabilitation training. The gamification of the system enhances the fun of training, while data quantification allows progress tracking, making the training more precise and effective. Additionally, after the game ends, data can be exported to Excel for further analysis to identify issues in the pushing process and optimize the training plan.

Behavioral: Lower Limb Strength Training Program with Visual Feedback

Interventions

This lower limb explosive strength training system integrates visual feedback games and is equipped with angle and force sensors to simultaneously output the power of the left and right legs, as well as maximum explosive force and pushing force. Users can immediately understand the balance of leg strength and make adjustments, making it particularly suitable for the elderly to improve lower limb strength or for rehabilitation training. The gamification of the system enhances the fun of training, while data quantification allows progress tracking, making the training more precise and effective. Additionally, after the game ends, data can be exported to Excel for further analysis to identify issues in the pushing process and optimize the training plan.

Lower Limb Strength Training Program with Visual Feedback

Eligibility Criteria

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

You may qualify if:

  • Age 65-80 years old
  • Physical fitness and health assessment results are suitable for exercise
  • Clear consciousness and no mental disorders .
  • Able to walk independently for more than 10 meters.

You may not qualify if:

  • Determined by doctors or other relevant professionals that they cannot accept cardiopulmonary testing and muscle strength training
  • The resting heartbeat exceeds 120 beats per minute, the systolic blood pressure exceeds 160mmHg, and the diastolic blood pressure exceeds 100mmHg.
  • Any stage of cancer and other hematologic diseases that affect research evaluation, such as: severe anemia.
  • Diseases related to cardiac pacemakers and arrhythmias.
  • Other neurological, muscular, or skeletal diseases that may affect the research assessment or severe contagious disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lower Limb Power Training Exercise Equipment

Kaohsiung City, Taiwan, No. 100, Shiquan 1st Road, Sanmin District, 807, Taiwan

Location

MeSH Terms

Interventions

Feedback, Sensory

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Study Officials

  • GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph.D.

    Department of Sports Science, Kaohsiung Medical University, Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Two long-term care centers were selected for the study. One center was randomly assigned to the experimental group through a lottery system, while the other served as the control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial with a parallel assignment model. Participants are randomly assigned to either the experimental group or the control group. The experimental group undergoes lower limb leg press power training combined with visual feedback games twice a week for 12 weeks, while the control group maintains their usual daily activities. The outcomes are assessed before and after the 12-week intervention, focusing on physical performance, cognitive function, and heart rate variability (HRV).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2024

First Posted

December 3, 2024

Study Start

September 18, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

This study aims to investigate the effects of lower limb leg press power training combined with visual feedback games on the physical and cognitive health of the elderly. With the aging population increasing, the decline in muscle strength and cognitive function has become a significant challenge for older adults. To address these health issues, this study plans to recruit 40 participants aged 65 and above and randomly assign long-term care centers into an experimental group and a control group. The experimental group will perform leg press training combined with visual feedback games twice a week for 12 weeks, while the control group will continue their usual daily activities.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
De-identified individual participant data (IPD) and supporting information will be available starting 2 years after the publication of the primary study results and will remain accessible for 5 years.
Access Criteria
The related supporting documents will only be made available to qualified researchers affiliated with academic institutions, medical organizations, or public health agencies. Applicants must submit a detailed research proposal and ethical approval documents, and access will be granted only upon approval.

Locations