Mild Cognitive ImpairmentNCT04689776
The Effectiveness of Dual Task Training in Elderly With Cognitive Decline
A study testing Dual-Task Training in people with Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Cognitive decline is the impairment of memory, execution, or language. Early detection of the individuals who manifest cognitive decline and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Dual-Task Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2020to 1 Jan 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to follow instruction (MMSE>= 20)
- self- or informant-reported memory or cognitive complaint.
Who cannot join
- recent myocardial infarction,heart failure,recent heart surgery,
- severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Ching-Yi Wu, ScD, +886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw
About this study
Cognitive decline is the impairment of memory, execution, or language. Early detection of the individuals who manifest cognitive decline and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Many studies have found that dual-task training combining cognitive training and exercise can improve cognitive function in older adults. However, it is yet not clear the appropriate frequency of the effective dual-task training for elderly with cognitive decline. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency dual-task training for elderly with cognitive decline.
Read the detailed description
Cognitive decline is the impairment of memory, execution, or language. Early detection of the individuals who manifest cognitive decline and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Many studies have found that dual-task training combining cognitive training and exercise can improve cognitive function in older adults. However, it is yet not clear the appropriate frequency of the effective dual-task training for elderly with cognitive decline. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency dual-task training for elderly with cognitive decline.
We anticipate recruiting a total of 80 participants with cognitive decline. The participants will be assigned into 2 groups: high frequency dual-task training (HF) and low frequency dual-task training (LF) groups. The participants of HF will receive a total of 36 training sessions, and each session will contain 90-120 minutes of training. The participants of LF will receive a total of 12 training sessions, and each session will contain 90-120 minutes of training. The programs are based on dual-task trainings which contain cognitive training and exercise simultaneously. For physical exercise, we will design the programs that involve balance or strength training components in the aerobic exercises. In terms of cognitive training, we will design self-made teaching aids and board games to train different domains of cognitive functions. We plan to assess the participants before and after the intervention programs. We expect that elders receiving dual-task training will improve on outcome measures, and the group with more frequency will have better performance. The results of the study will provide evidence of interventions for elderly with cognitive decline, thereby reducing the burden on their caregivers and the cost of medical resource.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Dual-Task Training
- Keywords
- Mild Cognitive Impairment, Cognitive Training, Exercise
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task TrainingBehavioural
The programs are based on dual-task trainings which contain cognitive training and exercise simultaneously. For physical exercise, we will design the programs that involve balance or strength training components in the aerobic exercises. In terms of cognitive training, we will design self-made teaching aids and board games to train different domains of cognitive functions. We plan to assess the participants before and after the intervention programs. We expect that elders receiving dual-task training will improve on outcome measures, and the group with more frequency will have better performance. The results of the study will provide evidence of interventions for elderly with cognitive decline, thereby reducing the burden on their caregivers and the cost of medical resource.
| Study group | Role | What they receive |
|---|---|---|
| High Frequency Dual-Task Training (HF) | Experimental | The participants of HF will receive a total of 36 training sessions, and each session will contain 90-120 minutes of training. Receives: Behavioral: Dual-Task Training |
| Low Frequency Dual-Task Training (LF) | Experimental | The participants of LF will receive a total of 12 training sessions, and each session will contain 90-120 minutes of training. Receives: Behavioral: Dual-Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of Mini-Mental State Exam (MMSE)
The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Stroop test
The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Timed up and go (TUG) test
The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then 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 and frail elderly (Podsiadlo \& Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Dual-task test
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
Subtests of the Wechsler Adult Intelligence Scale (WAIS) will be used to measure the cognitive functions of an individual. The WAIS have high reliability and validity, and is often used to differentiate individuals with cognitive deficits and those with intact cognitive functions. In addition, WAIS could be used to assess cognitive improvements after an intervention or treatment.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
Assess activities of daily living. There are 8 domains of function measured with the Lawton IADL scale, including ability to use phone,shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications,and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). For each category, circle the item description that most closely resembles the client's highest functional level (either 0 or 1).
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Wechsler Memory Scale (WMS)
The Wechsler Memory Scale (WMS) was designed to measure different memory functions. The subtests, including Word Lists, and Spatial Span will be used to assess the immediate, delayed, and working memory. Time to administer the WMS subtests is approximately 45 minutes. The total scores range from 0-48 for the immdiate memory, and 0-24 for the delayed memory. Higher values represent a better cognitive functioning.
Measured: baseline, posttest (around 12 weeks after baseline)
Secondary outcomes (3)
Change scores of the Community Integration Questionnaire (CIQ)
The social participation level will be assessed with the Community Integration Questionnaire (CIQ).It contains 15 items to evaluate the degree of integration into each of the three area of family, social network, and productive activities. The total scores range from 0 to 29 with larger numbers indicating better integration.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of Geriatric Depression Scale (GDS)
The Geriatric Depression Scale (GDS) - 15 items version is a self-administered questionnaire used to evaluate mood and depressive symptoms. The scores range is 0-15 and a score of 5 or greater taken as a possible indicator of depression.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Everyday Cognition scales (ECog)-12 items
To detect cognitive and functional decline. The ECog shows promise as a useful tool for the measurement of general and domain-specific everyday functions in the elderly. There are six domains (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided Attention) in ECog. Lower scores represent a higher level of function in daily life.
Measured: baseline, posttest (around 12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start16 Sep 2020
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching yi Wu, ScD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689776
- Sponsor's protocol ID
- 201912EM016
- Status last verified
- Jun 2022
- First submitted
- 29 Dec 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chuang IC, Chen IC, Wu YR, Li KY. Prediction and mediation analysis for treatment responses to combined cognitive and physical training for older adults. Sci Rep. 2024 May 8;14(1):10571. doi: 10.1038/s41598-024-61407-6.
PubMed 38720025Chen IC, Chuang IC, Chang KC, Chang CH, Wu CY. Dual task measures in older adults with and without cognitive impairment: response to simultaneous cognitive-exercise training and minimal clinically important difference estimates. BMC Geriatr. 2023 Oct 16;23(1):663. doi: 10.1186/s12877-023-04390-3.
PubMed 37845603
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dual Task Training in Elderly With Cognitive Decline
- ClinicalTrials.gov ID
- NCT04689776
- Acronym / sponsor ID
- 201912EM016
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Cognitive Training, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive decline is the impairment of memory, execution, or language. Early detection of the individuals who manifest cognitive decline and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Many studies have found that dual-task training combining cognitive training and exercise can improve cognitive function in older adults. However, it is yet not clear the appropriate frequency of the effective dual-task training for elderly with cognitive decline. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency dual-task training for elderly with cognitive decline.
Detailed description
Cognitive decline is the impairment of memory, execution, or language. Early detection of the individuals who manifest cognitive decline and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Many studies have found that dual-task training combining cognitive training and exercise can improve cognitive function in older adults. However, it is yet not clear the appropriate frequency of the effective dual-task training for elderly with cognitive decline. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency dual-task training for elderly with cognitive decline.
We anticipate recruiting a total of 80 participants with cognitive decline. The participants will be assigned into 2 groups: high frequency dual-task training (HF) and low frequency dual-task training (LF) groups. The participants of HF will receive a total of 36 training sessions, and each session will contain 90-120 minutes of training. The participants of LF will receive a total of 12 training sessions, and each session will contain 90-120 minutes of training. The programs are based on dual-task trainings which contain cognitive training and exercise simultaneously. For physical exercise, we will design the programs that involve balance or strength training components in the aerobic exercises. In terms of cognitive training, we will design self-made teaching aids and board games to train different domains of cognitive functions. We plan to assess the participants before and after the intervention programs. We expect that elders receiving dual-task training will improve on outcome measures, and the group with more frequency will have better performance. The results of the study will provide evidence of interventions for elderly with cognitive decline, thereby reducing the burden on their caregivers and the cost of medical resource.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Frequency Dual-Task Training (HF) | Experimental | Behavioral: Dual-Task TrainingThe participants of HF will receive a total of 36 training sessions, and each session will contain 90-120 minutes of training. |
| Low Frequency Dual-Task Training (LF) | Experimental | Behavioral: Dual-Task TrainingThe participants of LF will receive a total of 12 training sessions, and each session will contain 90-120 minutes of training. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- able to follow instruction (MMSE>= 20)
- self- or informant-reported memory or cognitive complaint.
Key exclusion criteria (2 listed)
- recent myocardial infarction,heart failure,recent heart surgery,
- severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Task TrainingThe programs are based on dual-task trainings which contain cognitive training and exercise simultaneously. For physical exercise, we will design the programs that involve balance or strength training components in the aerobic exercises. In terms of cognitive training, we will design self-made teaching aids and board games to train different domains of cognitive functions. We plan to assess the participants before and after the intervention programs. We expect that elders receiving dual-task training will improve on outcome measures, and the group with more frequency will have better performance. The results of the study will provide evidence of interventions for elderly with cognitive decline, thereby reducing the burden on their caregivers and the cost of medical resource. | Behavioural | High Frequency Dual-Task Training (HF), Low Frequency Dual-Task Training (LF) |
Primary outcome
Change scores of the Montreal Cognitive Assessment (MoCA)
Time frame: baseline, posttest (around 12 weeks after baseline)
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Change scores of Mini-Mental State Exam (MMSE)
Time frame: baseline, posttest (around 12 weeks after baseline)
The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.
Change scores of the Stroop test
Time frame: baseline, posttest (around 12 weeks after baseline)
The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
Change scores of the Timed up and go (TUG) test
Time frame: baseline, posttest (around 12 weeks after baseline)
The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then 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 and frail elderly (Podsiadlo \& Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent.
Change scores of the Dual-task test
Time frame: baseline, posttest (around 12 weeks after baseline)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
Time frame: baseline, posttest (around 12 weeks after baseline)
Subtests of the Wechsler Adult Intelligence Scale (WAIS) will be used to measure the cognitive functions of an individual. The WAIS have high reliability and validity, and is often used to differentiate individuals with cognitive deficits and those with intact cognitive functions. In addition, WAIS could be used to assess cognitive improvements after an intervention or treatment.
Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: baseline, posttest (around 12 weeks after baseline)
Assess activities of daily living. There are 8 domains of function measured with the Lawton IADL scale, including ability to use phone,shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications,and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). For each category, circle the item description that most closely resembles the client's highest functional level (either 0 or 1).
Change scores of the Wechsler Memory Scale (WMS)
Time frame: baseline, posttest (around 12 weeks after baseline)
The Wechsler Memory Scale (WMS) was designed to measure different memory functions. The subtests, including Word Lists, and Spatial Span will be used to assess the immediate, delayed, and working memory. Time to administer the WMS subtests is approximately 45 minutes. The total scores range from 0-48 for the immdiate memory, and 0-24 for the delayed memory. Higher values represent a better cognitive functioning.
3 secondary outcomes
Change scores of the Community Integration Questionnaire (CIQ)
Time frame: baseline, posttest (around 12 weeks after baseline)
Change scores of Geriatric Depression Scale (GDS)
Time frame: baseline, posttest (around 12 weeks after baseline)
Change scores of the Everyday Cognition scales (ECog)-12 items
Time frame: baseline, posttest (around 12 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Derived from this study: PubMed 38720025Chuang IC, Chen IC, Wu YR, Li KY. Prediction and mediation analysis for treatment responses to combined cognitive and physical training for older adults. Sci Rep. 2024 May 8;14(1):10571. doi: 10.1038/s41598-024-61407-6.
- Derived from this study: PubMed 37845603Chen IC, Chuang IC, Chang KC, Chang CH, Wu CY. Dual task measures in older adults with and without cognitive impairment: response to simultaneous cognitive-exercise training and minimal clinically important difference estimates. BMC Geriatr. 2023 Oct 16;23(1):663. doi: 10.1186/s12877-023-04390-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching yi Wu, ScD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Task Training in people with 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 2 inclusion and 2 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 5 Jul 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, posttest (around 12 weeks after baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04689776, which also lists 2 linked publications.
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 5 Jul 2022.