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

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: Active, not recruiting
• Conditions: Elderly (people Aged 65 or More)
• Intervention / Treatment: Behavioral: Lower Limb Strength Training Program with Visual Feedback

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Data	Height (centimeters)	Testing will be conducted in Week 0, Week 6, and Week 13.
Physiological Data	weight (kilogram)	Testing will be conducted in Week 0, Week 6, and Week 13
Physiological Data	systolic and diastolic blood pressure (mmHg)	Testing will be conducted in Week 0, Week 6, and Week 13
Physiological Data	blood oxygen (SaO2)	Testing will be conducted in Week 0, Week 6, and Week 13
Heart Rate Variability (HRV)	AVG HR (average heart rate)	Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)	HRV (heart rate variability)	Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)	RMSSD (root mean square of successive differences)	Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)	SDNN (standard deviation of NN intervals)	Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)	M RR int. (mean RR interval)	Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)	TP (total power)	Baseline measurement at Week 0 and follow-up measurement at Week 13.
Heart Rate Variability (HRV)	LF (low frequency power in ms² and Hz)	Baseline measurement at Week 0 and follow-up measurement at Week 13
Heart Rate Variability (HRV)	HF (high frequency power in ms² and Hz)	Baseline measurement at Week 0 and follow-up measurement at Week 13
Heart Rate Variability (HRV)	LF/HF ratio	Baseline measurement at Week 0 and follow-up measurement at Week 13
Cognitive Function Assessment	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	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	The 30-Second Sit-to-Stand Test	Testing will be conducted in Week 0, Week 6, and Week 13
Physical Performance Assessment	Functional Reach Test	Baseline measurement at Week 0 and follow-up measurement at Week 13

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University
• Investigators: 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

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Heart Rate Variability; Muscle Strength; Resistance Training; Cognitive Function; Lower Limb Power Training; Visual Feedback Games
• Other Study ID 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