跳至主要内容
临床试验/NCT07048561
NCT07048561招募中不适用

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

National Taiwan Normal University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Executive function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Executive function

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

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

Health-related physical fitness (flexibility)

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

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.

Health-related physical fitness (balance)

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

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.

Health-related physical fitness (cardiorespiratory endurance)

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

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.

Health-related physical fitness (muscular strength)

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

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.

Health-related physical fitness (muscular endurance)

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

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.

次要结局

  • Demographic questionnaire(From enrolment to the end of observation at one year.)
  • Resting blood pressure(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.)
  • Depressive symptoms (Geriatric Depression Scale)(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.)
  • Cognitive function (Mini-Mental State Examination, MMSE)(From enrolment to the end of observation at one year.)
  • Working memory (Digit Span Tests)(From enrolment to the end of observation at one year.)
  • Resting heart rate(From enrolment to the end of observation at one year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruei-Hong Li

Doctoral student

National Taiwan Normal University

研究点 (1)

Loading locations...

相似试验