NCT07048561

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Jun 2025Mar 2027

First Submitted

Initial submission to the registry

May 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

May 21, 2025

Last Update Submit

June 29, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    From enrolment to the end of observation at one year.

  • 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.

    From enrolment to the end of observation at one year.

  • 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.

    From enrolment to the end of observation at one year.

  • 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.

    From enrolment to the end of observation at one year.

  • 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.

    From enrolment to the end of observation at one year.

  • Executive function

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

    From enrolment to the end of observation at one year.

Secondary Outcomes (9)

  • Demographic questionnaire

    From enrolment to the end of observation at one year.

  • Sleep quality (Pittsburgh Sleep Quality Index, PSQI)

    From enrolment to the end of observation at one year.

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

    From enrolment to the end of observation at one year.

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

    From enrolment to the end of observation at one year.

  • Depressive symptoms (Geriatric Depression Scale)

    From enrolment to the end of observation at one year.

  • +4 more secondary outcomes

Study Arms (1)

Older adults

Older adults aged 65 and above.

Other: observation alone

Interventions

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

Also known as: one-year observation
Older adults

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population are older adults aged 65 or above.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Yu-Kai Chang, PhD

    National Taiwan Normal University

    STUDY DIRECTOR
  • Ruei-Hong Li, MS

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruei-Hong Li, MS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral student

Study Record Dates

First Submitted

May 21, 2025

First Posted

July 2, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

July 2, 2025

Record last verified: 2025-06

Locations