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Cognitively-normalNCT05225181

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

A study testing perform physical exercise and cognitive training in people with Cognitively-normal and Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
perform physical exercise and cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTaiwan
Study dates
1 Mar 2022to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age≥60
  • able to follow instruction
  • MoCA>26
  • not SCD or MCI or Dementia
  • age>=60
  • SCD(from Ecog-12)
Show all 9Show fewer
  • MoCA≥26
  • not MCI or Dementia
  • (1)age>=60 (2)20 ≦MoCA < 26 (3)MCI (3)not Dementia

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung Memotial Hospital

    Taoyuan, 333

    Ching-Yi Wu, ScD, +886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw

Other trials in Taiwan

About this study

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.

Being tested
perform physical exercise, cognitive training, control group
Keywords
aerobic exercise, cognitive training
Medical subject headings
Cognitive Dysfunction

What participants receive

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

  • perform physical exerciseBehavioural

    one 60-min session of physical training

  • cognitive trainingBehavioural

    one 60-min session of cognitive training

  • control groupBehavioural

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

Study groups in NCT05225181
Study groupRoleWhat they receive
sequential trainingExperimentalfirst perform physical exercise followed by cognitive training
Receives: Behavioral: perform physical exercise; Behavioral: cognitive training
simultaneous trainingExperimentalperform physical exercise and cognitive tasks simultaneously
Receives: Behavioral: perform physical exercise; Behavioral: cognitive training
control groupActive comparatorperform body stretching and health education courses
Receives: Behavioral: control group

What is being measured

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

  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.

    Measured: 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.

    Measured: 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

    Measured: 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.

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

Secondary outcomes (16)
  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).

    Measured: 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

    Measured: 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).

    Measured: 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.

    Measured: 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

    Measured: 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).

    Measured: 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).

    Measured: 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 .

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

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

  1. First posted4 Feb 2022
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05225181
Sponsor's protocol ID
202200014B0
Status last verified
Jan 2022
First submitted
23 Jan 2022
Last updated
24 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing perform physical exercise and cognitive training in people with Cognitively-normal and Mild Cognitive Impairment, run by Chang Gung Memorial Hospital 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Feb 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ching-yi Wu, ScD (#886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change scores of the Montreal Cognitive Assessment (MoCA). (time frame: baseline, after the intervention eight weeks, and at 3-month follow-up.). The study lists 4 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 24 Feb 2022.

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