Elderly (people Aged 65 or More)LPPT-VFGNCT06714175

Leg Press Power Training with Visual Feedback Games Improves Physical, Cognitive, and Heart Health in Seniors

A study testing Lower Limb Strength Training Program with Visual Feedback in people with Elderly (people Aged 65 or More), run by Kaohsiung Medical University at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Elderly (people Aged 65 or More)
What is being tested?: Lower Limb Strength Training Program with Visual Feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTaiwan
Study dates: 18 Sep 2024to Dec 2024
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 80 years
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

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

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Conditions: Elderly (people Aged 65 or More)
Being tested: Lower Limb Strength Training Program with Visual Feedback
Keywords: Elderly, Muscle Strength, Lower Limb Power Training, Visual Feedback Games, Cognitive Function, Heart Rate Variability, Resistance Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lower Limb Strength Training Program with Visual FeedbackBehavioural
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.

Study groups in NCT06714175
Study group	Role	What they receive
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. Receives: Behavioral: Lower Limb Strength Training Program with Visual Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Muscle Strength
Measurement of lower limb muscle strength (pound), including the quadriceps and hamstrings
Measured: Testing will be conducted in Week 0, Week 6, and Week 13
Muscle Strength
hand grip strength (kilogram)
Measured: Testing will be conducted in Week 0, Week 6, and Week 13

Secondary outcomes (17)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 2024Dec 2024

First posted3 Dec 2024
Study start18 Sep 2024
Primary completionDec 2024 (estimated)
Study completionDec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Elderly (people Aged 65 or More)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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).
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06714175
Sponsor's protocol ID: KMUHIRB-F(II)-202 20046
Other IDs: KMUHIRB-F(II)-202 20046
Acronym: LPPT-VFG
Status last verified: Nov 2024
First submitted: 13 Nov 2024
Last updated: 3 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
A Clinician-Patient Dual Behavior Change Framework to Leverage Informed Digital Nudges to Reduce Hospital Readmissions and Improve Patient Outcomes: A Trial for Scalable Strategy to Reduce Readmissions (PREVENT-R)
Readmission, Readmission Rates
RecruitingObservational study
Functional Decline and Quality of Life After Gastrointestinal Cancer Surgery in Older Adults
Cancer Abdomen, Elderly (People Aged 65 or More)
Recruiting
Effect of Exergaming Program Versus Neuromuscular Exercise in Elderly People With Motor Cognitive Risk Syndrome
Motoric Cognitive Risk Syndrome, Elderly (People Aged 65 or More)
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Recruiting
Dignity Therapy for Older Adults in Long-term Care Institutions
Elderly (People Aged 65 or More), Dignity

All Elderly (people Aged 65 or More) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06714175
Acronym / sponsor ID: LPPT-VFG / KMUHIRB-F(II)-202 20046
Conditions: Elderly (people Aged 65 or More)
Keywords: Elderly, Muscle Strength, Lower Limb Power Training, Visual Feedback Games, Cognitive Function, Heart Rate Variability, Resistance Training
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Kaohsiung Medical UniversityUniversity, hospital or other
Study start: 18 Sep 2024 (actual)
Primary completion: Dec 2024 (estimated)
Study completion: Dec 2024 (estimated)
First posted: 3 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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).

Arm	Type	Receives
Control Group	No intervention	–This group will not receive any specific muscle power intervention.
Lower Limb Strength Training Program with Visual Feedback	Experimental	Behavioral: Lower Limb Strength Training Program with Visual FeedbackThis 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.

Who may qualify

Ages: 65 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lower Limb Strength Training Program with Visual FeedbackThis 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.	Behavioural	Lower Limb Strength Training Program with Visual Feedback

Primary outcome

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
Muscle Strength
Time frame: Testing will be conducted in Week 0, Week 6, and Week 13
hand grip strength (kilogram)

17 secondary outcomes

Physiological Data
Time frame: 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
Physiological Data
Time frame: 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
Heart Rate Variability (HRV)
Time frame: 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.
Heart Rate Variability (HRV)
Time frame: 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.
Heart Rate Variability (HRV)
Time frame: 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.
Heart Rate Variability (HRV)
Time frame: 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
Heart Rate Variability (HRV)
Time frame: 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
Physical Performance Assessment
Time frame: 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
Physical Performance Assessment
Time frame: Baseline measurement at Week 0 and follow-up measurement at Week 13

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
Individual participant dataSharing planned: Yes. 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.

Related trials for Elderly (people Aged 65 or More)

Not yet recruiting
A Clinician-Patient Dual Behavior Change Framework to Leverage Informed Digital Nudges to Reduce Hospital Readmissions and Improve Patient Outcomes: A Trial for Scalable Strategy to Reduce Readmissions (PREVENT-R)
Readmission, Readmission Rates
RecruitingObservational study
Functional Decline and Quality of Life After Gastrointestinal Cancer Surgery in Older Adults
Cancer Abdomen, Elderly (People Aged 65 or More)
Recruiting
Effect of Exergaming Program Versus Neuromuscular Exercise in Elderly People With Motor Cognitive Risk Syndrome
Motoric Cognitive Risk Syndrome, Elderly (People Aged 65 or More)
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Recruiting
Dignity Therapy for Older Adults in Long-term Care Institutions
Elderly (People Aged 65 or More), Dignity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Department of Sports Science, Kaohsiung Medical University, Taiwan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lower Limb Strength Training Program with Visual Feedback in people with Elderly (people Aged 65 or More), run by Kaohsiung Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Strength (time frame: Testing will be conducted in Week 0, Week 6, and Week 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06714175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.