Leg Press Power Training with Visual Feedback Games Improves Physical, Cognitive, and Heart Health in Seniors (LPPT-VFG)

November 28, 2024 updated by: Yi-Wei Kao, Kaohsiung Medical University

Effects of Lower Limb Leg Press Power Training Combined with Visual Feedback Games on Physical Performance, Cognitive Function, and Heart Rate Variability in the Elderly

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • No. 100, Shiquan 1st Road, Sanmin District
      • Kaohsiung City, Taiwan, No. 100, Shiquan 1st Road, Sanmin District, Taiwan, 807
        • Lower Limb Power Training Exercise Equipment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
This group will not receive any specific muscle power intervention.
Experimental: Lower Limb Strength Training Program with Visual Feedback
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle Strength
Time Frame: Testing will be conducted in Week 0, Week 6, and Week 13
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
Time Frame: Testing will be conducted in Week 0, Week 6, and Week 13
hand grip strength (kilogram)
Testing will be conducted in Week 0, Week 6, and Week 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physiological Data
Time Frame: Testing will be conducted in Week 0, Week 6, and Week 13.
Height (centimeters)
Testing will be conducted in Week 0, Week 6, and Week 13.
Physiological Data
Time Frame: Testing will be conducted in Week 0, Week 6, and Week 13
weight (kilogram)
Testing will be conducted in Week 0, Week 6, and Week 13
Physiological Data
Time Frame: Testing will be conducted in Week 0, Week 6, and Week 13
systolic and diastolic blood pressure (mmHg)
Testing will be conducted in Week 0, Week 6, and Week 13
Physiological Data
Time Frame: Testing will be conducted in Week 0, Week 6, and Week 13
blood oxygen (SaO2)
Testing will be conducted in Week 0, Week 6, and Week 13
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.
AVG HR (average heart rate)
Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.
HRV (heart rate variability)
Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.
RMSSD (root mean square of successive differences)
Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.
SDNN (standard deviation of NN intervals)
Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.
M RR int. (mean RR interval)
Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.
TP (total power)
Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13
LF (low frequency power in ms² and Hz)
Baseline measurement at Week 0 and follow-up measurement at Week 13
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13
HF (high frequency power in ms² and Hz)
Baseline measurement at Week 0 and follow-up measurement at Week 13
Heart Rate Variability (HRV)
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13
LF/HF ratio
Baseline measurement at Week 0 and follow-up measurement at Week 13
Cognitive Function Assessment
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13
Cognitive function is assessed using the Taiwan Chinese version of the Montreal Cognitive Assessment (MoCA), authorized by the original Korean publisher. This assessment evaluates various cognitive domains to provide a comprehensive understanding of cognitive health.
Baseline measurement at Week 0 and follow-up measurement at Week 13
Physical Performance Assessment
Time Frame: Testing will be conducted in Week 0, Week 6, and Week 13
Physical performance is evaluated using the Short Physical Performance Battery (SPPB)
Testing will be conducted in Week 0, Week 6, and Week 13
Physical Performance Assessment
Time Frame: Testing will be conducted in Week 0, Week 6, and Week 13
The 30-Second Sit-to-Stand Test
Testing will be conducted in Week 0, Week 6, and Week 13
Physical Performance Assessment
Time Frame: Baseline measurement at Week 0 and follow-up measurement at Week 13
Functional Reach Test
Baseline measurement at Week 0 and follow-up measurement at Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph.D., Department of Sports Science, Kaohsiung Medical University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUHIRB-F(II)-202 20046 (Other Identifier: Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings