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Status unknownNCT05225181Updated Feb 24, 2022

Effects of the Combining Physical Exercise and Cognitive Training for the Community-based Elderly

An interventional study of perform physical exercise and cognitive training in Cognitively-normal, Mild Cognitive Impairment and Subjective Cognitive Decline, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study summary

This study aims to (1) determine the intervention effects of sequential and simultaneous training on cognitive function and health-related function for cognitively-normal elderly and elderly with Mild Cognitive Impairment(MCI) and Subjective Cognitive Decline(SCD); (2) compare which combination approach is more advantageous for improvement on outcome measures.

Read the detailed description

The investigators will recruit 30 cognitively-normal elderly and 30 elderly with Mild Cognitive Impairment(MCI) and 30 elderly with Subjective Cognitive Decline(SCD). Participants will be randomly assigned to one of three groups: sequential training (first perform physical exercise followed by cognitive training), simultaneous training (perform physical exercise and cognitive tasks simultaneously), and control group (perform body stretching and health education courses). All participants will receive trainings for 120 minutes per day, one day per week for 12 weeks. The outcome will include measurements that evaluate the cognitive, physical, daily functions, quality of life, and social participation. Participants will be assessed at baseline, after the intervention, and at 3-month follow-up. Repeated measures of analysis of variance (ANOVA) will be used to evaluate the changes in outcome measures at three different time points for the elderly with cognitively-normal, Mild Cognitive Impairment(MCI) and Subjective Cognitive Decline(SCD), respectively. The investigators also use the analysis of covariance (ANCOVA) to investigate the differences between the Mild Cognitive Impairment(MCI) and Subjective Cognitive Decline(SCD) groups on the outcome measures.

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Conditions studied

  • Cognitively-normal
  • Mild Cognitive Impairment
  • Subjective Cognitive Decline

Keywords

  • aerobic exercise
  • cognitive training
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In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 90 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

cognitively-normal elderly

Inclusion Criteria:

  1. age≥60
  2. able to follow instruction
  3. MoCA>26
  4. not SCD or MCI or Dementia

Exclusion Criteria:

  1. concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
  2. have unstable cardiovascular status such as uncontrolled hypertension

SCD

Inclusion Criteria:

  1. age>=60
  2. SCD(from Ecog-12)
  3. MoCA≥26
  4. not MCI or Dementia

Exclusion Criteria:

  1. concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
  2. have unstable cardiovascular status such as uncontrolled hypertension

MCI

Inclusion Criteria:

(1)age>=60 (2)20 ≦MoCA \< 26 (3)MCI (3)not Dementia

Exclusion Criteria:

  1. concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
  2. have unstable cardiovascular status such as uncontrolled hypertension
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    sequential training

    first perform physical exercise followed by cognitive training

    Behavioral: perform physical exercise · Behavioral: cognitive training

  • Experimental
    simultaneous training

    perform physical exercise and cognitive tasks simultaneously

    Behavioral: perform physical exercise · Behavioral: cognitive training

  • Active comparator
    control group

    perform body stretching and health education courses

    Behavioral: control group

Interventions

  • Behavioralperform physical exercise

    one 60-min session of physical training

  • Behavioralcognitive training

    one 60-min session of cognitive training

  • Behavioralcontrol group

    perform body stretching(15min) and health education courses(90min)

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What researchers measure

Primary outcomes

  1. Change scores of the Montreal Cognitive Assessment (MoCA).

    The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  2. Change scores of Wechsler Memory Scale (WMS)

    including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  3. Change scores of Stroop test

    The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  4. Change scores of Color trials test

    For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

Secondary outcomes

  1. Change scores of Verbal fluency tests

    Verbal fluency tests are a kind of psychological test in which participants have to produce as many words as possible from a category in a given time (usually 60 seconds).

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  2. Change scores of Wechsler Adult Intelligence Scale; WAIS

    The digit symbol test involves a key consisting of the numbers 1-9, each paired with a unique, easy-to-draw symbol such as a "V", "+" or "\>". Matrix Reasoning This is a nonverbal reasoning task in which individuals are asked to identify patterns in designs. This subtest measures: * non-verbal reasoning skills * broad visual intelligence * perceptual organization skills

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  3. Change scores of the short (12-item) form of the Everyday Cognition Scale (ECog-12)

    The short (12-item) form of the Everyday Cognition Scale (ECog-12), which was developed as an informant-rated report of cognitively mediated functional abilities in older adults. The ECog-12 asks participants to rate their current ability to perform cognitively mediated daily tasks related to everyday memory, language, visuospatial abilities, and executive functions compared with their ability to do the same task 10 years ago. Items are rated on a scale of 1-4, with 1 = Better or no change and 4 = Consistently much worse. The global, executive, and memory ECog-12 sub-domain scores were generated by averaging over the component items (sum of items/number of items) to maintain a range of 1 to 4 (with higher scores reflecting greater self-reported SCD).

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  4. Change scores of Dual-task tests

    The dual-task test evaluates the ability to shift attention between one task and another. Participants will sit and perform the box and block test (BBT) or walk 10 meters while doing secondary cognitive or motor tasks. Two cognitive secondary tasks will be performed by the participants: (1) arithmetic task: participants will be asked to perform serial subtractions by 7 starting from 100 or random two-digit numbers (e.g., Baetens et al., 2013); (2) tone discrimination task: participants will be presented a number of low and high-pitched tones and they will respond to either the high or low-pitched tones during the trial. Both cognitive task performances will be recorded and the results will be compared to single cognitive task performance. In addition to the cognitive dual-task, participants will perform a motor task (e.g., holding a cup of water) while walking.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  5. Change scores of Six-minute walk test,6MWT

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. T

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  6. Change scores of Timed up and go (TUG)

    The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers in frail elderly (Podsiadlo \& Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent (Blankevoort, van Heuvelen, \& Scherder, 2013).

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  7. Change scores of 30 second chair stand test,CST

    The 30 second sit-to-stand will be assessed to indicate the strength and endurance level of the lower extremities. The participants will be asked to stand up from a standardized chair and then sit down as many times as possible within 30 seconds. The feasibility and reliability of using sit-to-stand test in people with cognitive impairment have been established to be good (Blankevoort et al., 2013).

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  8. Change scores of International Physical Activity Questionnaires (IPAQ)

    The Chinese version of the International Physical Activity Questionnaires (IPAQ) is an international measure for health-related physical activity. A short form of IPAQ will be used to assess changes in physical activity before and after intervention in this study. The reliability and validity of IPAQ has been established across 12 countries . The self-report, short-form IPAQ , consists of three questions about days and time of vigorous, moderate, and walking activity in bouts of 10 min, with one question about daily sedentary time in the preceding seven days. The questionnaire was preceded by completion instructions and three questions about the types of vigorous, moderate, and light activity undertaken .

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  9. Change scores of Grip strength

    The investigator will use hand dynamometer to measure grip strength of both hands while the participant is seated, with the elbow at 90-degree flexion. The investigator will record the mean value of 3 attempts. Grip strength was measured using a digital dynamometers method, which is a tool with an adjustable grip span, ranging from 3.5 to 7 cm and weighing from 5 to 100 kg with minimal difference around 0.1 kg . All the participants were in a sitting position with fully extended elbows . Then, the investigator measured Grip strength on the dominant hand after 2-3 minutes of resting.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  10. Change scores of short physical performance battery,SPPB

    The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests . It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  11. Change scores of The Clinical Frailty Scale (CFS)

    The aim of this scoping review is to identify and document the nature and extent of research evidence related to the Clinical Frailty Scale (CFS). The association of Clinical Frailty Scale (CFS) score with clinical outcomes highlights its utility in the care of the aging population. The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  12. Change scores of Reported Edmonton Frail Scale (REFS)

    Reported Edmonton Frail Scale is an adaptation of Edmonton Frail Scale, that can be performed in less than 10 min by any healthcare professional. Reported Edmonton Frail Scale substitutes the last domain on Edmonton Frail Scale, the physical performance measure, with three self-assessed physical performance questions . This is ideal for use in busy cardiology clinics when patients are being assessed for suitability for intervention.Scoring for the Reported Edmonton Frail Scale range is 0 to18. Not Frail:0-5 ;Apparently Vulnerable:6-7; Mildly Frail:8-9;Moderate Frailty:10-11;Sever Frailty:12-18.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  13. Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL

    The Amsterdam Instrumental Activity of Daily Living (A-IADL) is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in (early) dementia. The questionnaire is completed by a caregiver, such as a relative or friend. Each item has a 5-point scale response option (scored 0-4). The scoring of the Amsterdam Instrumental Activity of Daily Living is calculated using item response theory .Lower scores indicating poorer performance.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  14. Change scores of the World Health Organization Quality of Life-Old(WHOQOL-OLD)

    The World Health Organization Quality of Life-Old questionnaires demonstrate acceptable psychometric performance in a convenience sample of Taiwan older people. It are valuable measures of Quality of Life-Old for use with older people.Time frame for assessment is the past two weeks. The items are distributed into 4 domains (physical; psychological, social and environmental health) and 25 facets.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  15. Change scores of Geriatric Depression Scale,GDS

    The Geriatric Depression Scale (GDS) is a screening test originally developed by J.A. Yesavage and colleagues in 1982 that is used to identify symptoms of depression in older adults. The scale is a 30-item, self-report instrument that uses a "Yes/No" format.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

  16. Change scores of Community Integration Questionnaire, CIQ

    The community integration questionnaire (CIQ) was designed to assess home integration, social integration and productive activity in persons with acquired brain injury. The instrument consists of 15 items and can be completed by self report or with the assistance of a family member or caregiver familiar with the person's health status and social activities.

    Time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.

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Study locations

1 site
  • Chang Gung Memotial Hospital
    Taoyuan, 333, Taiwan
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05225181
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Mar 1, 2022 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Feb 24, 2022

Study contacts

Ching-yi Wu, ScD
Contact
cywu@mail.cgu.edu.tw
#886-3-2118800 ext. 5761

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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