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NCT Number: NCT06714175

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Elderly (People Aged 65 or More)

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lower Limb Power Training Exercise Equipment

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lower Limb Strength Training Program with Visual Feedback

Behavioral

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.

Primary outcomes

  1. 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

  2. Muscle Strength

    Time frame: Testing will be conducted in Week 0, Week 6, and Week 13

    hand grip strength (kilogram)

Secondary outcomes

  1. Physiological Data

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

    Height (centimeters)

  2. Physiological Data

    Time frame: Testing will be conducted in Week 0, Week 6, and Week 13

    weight (kilogram)

  3. Physiological Data

    Time frame: Testing will be conducted in Week 0, Week 6, and Week 13

    systolic and diastolic blood pressure (mmHg)

  4. Physiological Data

    Time frame: Testing will be conducted in Week 0, Week 6, and Week 13

    blood oxygen (SaO2)

  5. Heart Rate Variability (HRV)

    Time frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.

    AVG HR (average heart rate)

  6. Heart Rate Variability (HRV)

    Time frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.

    HRV (heart rate variability)

  7. 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)

  8. Heart Rate Variability (HRV)

    Time frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.

    SDNN (standard deviation of NN intervals)

  9. Heart Rate Variability (HRV)

    Time frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.

    M RR int. (mean RR interval)

  10. Heart Rate Variability (HRV)

    Time frame: Baseline measurement at Week 0 and follow-up measurement at Week 13.

    TP (total power)

  11. 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)

  12. 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)

  13. Heart Rate Variability (HRV)

    Time frame: Baseline measurement at Week 0 and follow-up measurement at Week 13

    LF/HF ratio

  14. 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.

  15. 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)

  16. Physical Performance Assessment

    Time frame: Testing will be conducted in Week 0, Week 6, and Week 13

    The 30-Second Sit-to-Stand Test

  17. Physical Performance Assessment

    Time frame: Baseline measurement at Week 0 and follow-up measurement at Week 13

    Functional Reach Test

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Registry information

Official study 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

Acronym: LPPT-VFG

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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