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Older Adults (65 Years and Older)NCT07048561

Health-related Physical Fitness and Executive Function in Older Adults: A Prospective Study

An observational study of Older Adults (65 Years and Older) and Fitness Testing, run by National Taiwan Normal University at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to explore the relationship between health-related physical fitness and behavioural and electrophysiological aspects of cool and hot executive function in older adults through a year prospective study design. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
observation alone
How many people
200 participants
Where
1 siteTaiwan
Study dates
1 Jun 2025to 31 Mar 2027
Phase
Observational
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Study population are older adults aged 65 or above.

Who may be able to join

  • Age 65 or above.
  • Able to engage in fitness testing.
  • Normal vision or corrected-to-normal vision.

Who cannot join

  • Suffering from cardiopulmonary-related diseases.
  • Suffering from cognitive, neurological or psychiatric disorders (e.g., dementia, Parkinson's disease, epilepsy, depression, schizophrenia, etc.).
  • Suffering from infectious diseases (e.g., hepatitis, human immunodeficiency virus or Creutzfeldt-Jakob disease).
  • Having a history of drug or alcohol abuse.
  • Having colour vision deficiency (e.g., colour blindness).
  • Having a family history of aneurysm.
  • Taking medications that affect brain function.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ruei-Hong Li, MS contact

+886-988163220

rueihongli@gmail.com

Taiwan1 site, 1 recruiting
  • National Taiwan Normal University

    Taipei

    Ruei-Hong Li, +886277493223, rueihongli@gmail.com

    Ruei-Hong Li

    Recruiting

Other trials in Taiwan

About this study

Official title: Changes in Health-related Physical Fitness on the Behavioural and Electrophysiological Aspects of Cool and Hot Executive Function in Older Adults: A Prospective Study

This study aims to explore the relationship between health-related physical fitness and behavioural and electrophysiological aspects of cool and hot executive function in older adults through a year prospective study design. The main questions it aims to answer whether changes in health-related physical fitness will positively predict changes in behavioural and electrophysiological aspects of cool and hot executive functions in older adults. The participants will be asked to complete pre-test, a one-year observation period, and post-test. Both pre- and post-tests will measure health-related physical fitness, executive function, and various demographic variables and covariates. Health-related physical fitness assessments include cardiorespiratory endurance (YMCA submaximal cycle test), muscular strength (grip strength, chest press, and leg press), muscular endurance (30-second chair stand, 30-second bicep curl), flexibility (range of motion), and balance (Balance Error Scoring System). Executive function will be measured using the Stroop test and emotional Stroop test, with concurrent EEG recording of brain activity. Demographic variables and covariates include sex, age, years of education, annual income, Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQ) Taiwan short form, World Health Organisation Quality of Life Brief Assessment (WHOQOL-BREF) Taiwan version, Geriatric Depression Scale, Mini-Mental State Examination (MMSE), digit span tests, and step count recorded by mobile phones or watches over the previous month, resting heart rate, and resting blood pressure. No interventions will be conducted during the one-year observation period, maintaining participants' normal daily living conditions.

Read the detailed description

Executive function refers to higher-order cognitive functions responsible for planning, organisation, and problem-solving. These functions decline with age and are crucial for maintaining independence and quality of life in older adults. Research indicates that health-related physical fitness may serve as a protective factor against executive function decline, encompassing cardiorespiratory endurance, body composition, muscular strength, muscular endurance, flexibility, and balance. However, no studies have simultaneously tracked the relationship between these health-related physical fitness components and executive function. Thus, this study employs a one-year prospective design to investigate the relationship between changes in health-related physical fitness and executive function in older adults. The study will recruit 200 older adults aged 65 or above for pre-test, a one-year observation period, and post-test. Both pre- and post-tests will measure health-related physical fitness, executive function, and various demographic variables and covariates. Health-related physical fitness assessments include cardiorespiratory endurance (YMCA submaximal cycle test), muscular strength (grip strength, chest press, and leg press), muscular endurance (30-second chair stand, 30-second bicep curl), flexibility (range of motion), and balance (Balance Error Scoring System). Executive function will be measured using the Stroop test and emotional Stroop test, with concurrent EEG recording of brain activity. Demographic variables and covariates include sex, age, years of education, annual income, Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire (IPAQ) Taiwan short form, World Health Organisation Quality of Life Brief Assessment (WHOQOL-BREF) Taiwan version, Geriatric Depression Scale, Mini-Mental State Examination (MMSE), digit span tests, and step count recorded by mobile phones or watches over the previous month, resting heart rate, and resting blood pressure. No interventions will be conducted during the one-year observation period, maintaining participants' normal daily living conditions. This study will provide preliminary evidence on the relationship between health-related fitness and executive function, offering guidance to the public and government agencies for developing exercise programmes aimed at enhancing executive function. By understanding key health-related physical fitness components for exercise design, Taiwan, which faces an ageing society, may potentially reduce government financial and social burdens related to dementia care.

Being tested
observation alone

What participants receive

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

  • observation aloneOther

    Also called one-year observation

    No interventions will be conducted during the one-year observation period, maintaining participants' normal daily living conditions.

Study groups in NCT07048561
Study groupRoleWhat they receive
Older adultsOlder adults aged 65 and above.
Receives: Other: observation alone

What is being measured

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

  1. Health-related physical fitness (cardiorespiratory endurance)

    Cardiorespiratory endurance was assessed using the YMCA Submaximal Cycle Ergometer Test. The protocol comprised four 3-minute stages at 50 rpm, beginning with a 25W workload in stage one. Stage two workload was determined by steady-state heart rate (HR) achieved during the final two minutes of stage one (tolerance ±5 beats/min): <80 beats/min = 125W; 80-89 beats/min = 100W; 90-100 beats/min = 75W; >100 beats/min = 50W. Stages three and four increased workload by 25W increments, targeting two consecutive steady-state HRs between 110 beats/min and 85% HRmax. Stage duration was extended by one-minute intervals when steady-state criteria were not met (HR variation >5 beats/min or <110 beats/min during final two minutes). Peak VO₂ was estimated using established formulae.

    Measured: From enrolment to the end of observation at one year.

  2. Health-related physical fitness (muscular strength)

    Muscular strength was assessed by handgrip strength, chest press, and leg press. Hand grip strength was assessed using a digital hand dynamometer. Chest and leg press was assessed using chest and leg press machines, respectively, following a standardised four-stage protocol. Participants initially performed 10-12 repetitions at minimal resistance for familiarisation and warm-up. Subsequently, they completed 5-10 repetitions with progressively increasing resistance (5-10% increments for upper body; 10-20% for lower body), with 3-5 minute rest intervals between attempts. This process continued until participants could perform fewer than five repetitions. The final successfully completed workload served as the basis for one-repetition maximum (1-RM) estimation using established conversion tables.

    Measured: From enrolment to the end of observation at one year.

  3. Health-related physical fitness (muscular endurance)

    Muscular endurance was assessed using the 30-second bicep curl and 30-second chair stand from the Senior Fitness Test. The 30-second bicep curl required participants to sit upright on the chair edge, favouring their dominant side, with feet flat on the ground. Using a handshake grip, they held a dumbbell (5 pounds for females, 8 pounds for males) in their dominant hand, with the arm initially hanging straight down beside the chair. Complete arm flexion and extension constituted one repetition, with participants instructed to perform maximal repetitions within 30 seconds. The 30-second chair stand required participants to sit centrally with backs straight, feet flat on the ground, and arms crossed over their chests. They performed maximal repetitions of standing up and sitting down within 30 seconds. The total number of repetitions in each test served as the respective muscular endurance indicator.

    Measured: From enrolment to the end of observation at one year.

  4. Health-related physical fitness (flexibility)

    Flexibility was assessed using range of motion measurements obtained with a joint goniometer. The goniometer's fulcrum was positioned at the centre of the target joint, with arms aligned to the bony landmarks of the proximal and distal segments. The resulting angular measurement represented the joint's range of motion.

    Measured: From enrolment to the end of observation at one year.

  5. Health-related physical fitness (balance)

    Balance was assessed using the Balance Error Scoring System (BESS). Participants maintained six stances for 20 seconds each with eyes closed and hands on hips: double-leg stance, single-leg stance on the non-dominant foot, and tandem stance with the non-dominant heel against the dominant toe. These three positions were performed on both a firm surface and a medium-density foam pad (45 cm × 45 cm × 13 cm).

    Errors were recorded for removing hands from hips, opening eyes, stepping, excessive hip movement (>30°), or lifting the foot. Each trial was scored with a maximum of 10 errors, with participants unable to maintain stance for 5 seconds receiving the maximum score. The total BESS score represented cumulative errors across all six conditions.

    Measured: From enrolment to the end of observation at one year.

  6. Executive function

    Executive function will be measured using the Stroop test and emotional Stroop test, with concurrent EEG recording of brain activity.

    Measured: From enrolment to the end of observation at one year.

Secondary outcomes (9)
  1. Demographic questionnaire

    Demographic questionnaire include sex, age, years of education, and step count recorded by mobile phones or watches over the previous month.

    Measured: From enrolment to the end of observation at one year.

  2. Sleep quality (Pittsburgh Sleep Quality Index, PSQI)

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-report questionnaire comprising 19 items that evaluate sleep patterns over the preceding month. The instrument generates seven component scores: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, sleep medication use, and daytime dysfunction. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21. Scores ≤5 indicate good sleep quality, whilst scores >5 suggest poor sleep quality, with higher values reflecting greater sleep impairment.

    Measured: From enrolment to the end of observation at one year.

  3. Physical activity (Taiwan version of the International Physical Activity Questionnaire, IPAQ)

    Physical activity was assessed using the Taiwan version of the International Physical Activity Questionnaire (IPAQ). This seven-item instrument measures metabolic equivalents (METs) across work, household, leisure, and sedentary activities over a seven-day period, expressed in kcal/kg/min. Activities are categorised as vigorous, moderate, and light intensity (walking), alongside sedentary behaviour, with frequency (days/week) and duration (minutes/session) recorded for each intensity level.

    Measured: From enrolment to the end of observation at one year.

  4. Quality of life (Taiwan version of World Health Organisation Quality of Life Brief Assessment, WHOQOL-BREF)

    Quality of life was assessed using the Taiwan version of the World Health Organization Quality of Life Questionnaire-Brief Form (WHOQOL-BREF), a validated 24-item instrument utilising a five-point Likert scale. Participants evaluated their experiences and perceptions over the preceding two weeks across four domains: physical health, psychological health, social relationships, and environmental factors. Two additional items assessed overall quality of life and general health satisfaction. This instrument provides comprehensive multidimensional assessment suitable for clinical and research applications.

    Measured: From enrolment to the end of observation at one year.

  5. Depressive symptoms (Geriatric Depression Scale)

    The Geriatric Depression Scale (GDS-15) comprises 15 items designed to assess depressive symptoms in older adults. Scores range from 0-15, with higher values indicating greater depressive symptomatology. Clinical cut-off points are established as follows: scores of 0-4 indicate normal mood, 5-8 suggest mild depression, 9-11 indicate moderate depression, and scores ≥12 suggest severe depression.

    Measured: From enrolment to the end of observation at one year.

  6. Cognitive function (Mini-Mental State Examination, MMSE)

    The Mini-Mental State Examination (MMSE) is a widely utilised cognitive screening instrument that provides quantitative assessment of cognitive function. This 30-item assessment evaluates multiple cognitive domains: orientation (10 points), memory encoding (3 points), attention and calculation (5 points), recall (3 points), and language with visuospatial construction (9 points). Total scores range from 0 to 30, with scores below 25 indicating potential cognitive impairment.

    Measured: From enrolment to the end of observation at one year.

  7. Working memory (Digit Span Tests)

    Working memory was assessed using the Digit Span subtest from the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III). The subtest comprises forward digit sequences (16 items) and backward digit sequences (14 items), administered orally without written aids. Participants were required to reproduce number sequences verbally, either in the original order (forward condition) or in reverse order (backward condition). Each correct response received one point, yielding maximum possible scores of 16 and 14 points for the forward and backward conditions, respectively.

    Measured: From enrolment to the end of observation at one year.

  8. Resting heart rate

    Resting heart rate was measured using the Polar H10 chest-worn heart rate monitor. Participants were seated in a quiet, temperature-controlled environment for a minimum of five minutes prior to measurement to ensure cardiovascular stabilisation. Heart rate data were recorded continuously over a three-minute period.

    Measured: From enrolment to the end of observation at one year.

  9. Resting blood pressure

    Resting blood pressure was assessed using an automated oscillometric sphygmomanometer. Measurements were taken from the participant's non-dominant arm following a standardised protocol, with participants seated upright and feet flat on the floor.

    Measured: From enrolment to the end of observation at one year.

Timeline

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

  1. First posted2 Jul 2025
  2. Study start1 Jun 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07048561
Sponsor's protocol ID
NTNU_PACNL_HPF_EF_P
Status last verified
Jun 2025
First submitted
21 May 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Older Adults (65 Years and Older) and Fitness Testing, run by National Taiwan Normal 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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?

Contact Ruei-Hong Li, MS (+886-988163220, rueihongli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related physical fitness (cardiorespiratory endurance) (time frame: From enrolment to the end of observation at one year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Jul 2025.

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