Mild Cognitive ImpairmentNCT02512627
Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment
A study testing Cognitive training and Physical exercise in people with Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 9 sites in Taiwan.
Trial summary
This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cognitive training and Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 9 sitesTaiwan
- Study dates
- 30 Jan 2015to 13 Mar 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to follow instruction,
- clinical dementia rating (CDR) = 0.5 or 1,
- self- or informant-reported memory or cognitive complaint, and
- able to perform activities of daily living (Barthel Index ≥ 70).
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
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
Baliexcelsior Nursing Home
New Taipei City, 249
Pine nursing home
Taichung, 412
Zhishan community home
Taipei, 11150
Bailing clinics and nursing homes
Taipei, 11165
Shihlin cum day care center
Taipei, 111
Xihu day care center
Taipei, 11443
TaoSheng Nursing home
Taipei
Chang Gung Memorial Hospital
Taoyuan, 333
Chang Gung Memorial Hospital Taoyuan Branch
Taoyuan
About this study
Official title: Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.
Read the detailed description
Background and study aims:
Mild cognitive impairment (MCI) or minor neurocognitive disorder is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The age-adjusted prevalence of MCI in Taiwan is approximately 18%, while women have higher prevalence for MCI than men. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in 5 years. Therefore, early detection of the individuals who manifest MCI and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Previous studies found that cognitive training or exercise has emerged as an important therapeutic approach for individuals with MCI. However, the intervention effects of combining exercise and cognitive training remain to be determined. Furthermore, whether exercise and cognitive training should be administered in sequential order or simultaneously is an important question to pursue. The overall goal of this study is to determine and compare the intervention effects cognitive training, exercise, and combining cognitive and exercise training in individuals with MCI.
Who can participate? Individuals with MCI.
What does the study involve? The participants will receive a total of 36 training sessions, and each session will contain 90 minutes of training. Training frequency will be 2-3 times per week for 12-18 weeks. All participants will received pretreatment test, post treatment test, and a 6-month follow-up test.
What are the possible benefits and risks of participating? The possible benefits include improvement in cognitive, physical, and daily functions. There are no risks for participating.
Where to conduct the study? The investigators anticipate recruiting a total of 80 participants from geriatric day care centers and nursing homes from multiple cities in Taiwan.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cognitive training, Physical exercise
- Keywords
- mild cognitive impairment, exercise, cognitive training
- 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.
Cognitive trainingBehavioural
visuospatial, attention, memory, and executive abilities
Physical exerciseBehavioural
endurance, balance, and mobility
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training group (Cog) | Active comparator | The BrainHQ program will be used to train different cognitive functions of the participants. The participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions. The tasks will become more difficult as the participants progress in their abilities. Receives: Behavioral: Cognitive training |
| Physical exercise group (PE) | Active comparator | The participants in this group participate in multimodal exercise programs including aerobic exercise, balance, and strength training. The entire exercise program for the PE group will contain 10 minutes of warm-up, 70 minutes of physical exercise, and 10 minutes of cool-down. The 70 minutes of exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period. Receives: Behavioral: Physical exercise |
| Sequential training group (Seq) | Experimental | The participants in this group will first perform 45 minutes of physical exercise followed by 45 minutes of cognitive training. The physical exercise training will be similar to the programs used in the PE group. The entire exercise program for the PE group will contain 5 minutes of warm-up, 35 minutes of physical exercise, and 5 minutes of cool-down. The cognitive training will be implemented with BrainHQ similar to what has been described in the COG group. Receives: Behavioral: Cognitive training; Behavioral: Physical exercise |
| Dual-task training group (Dual) | Experimental | In this group, the participants will be instructed to perform physical exercise and cognitive tasks simultaneously (e.g., math calculation while stepping). The difficulty of the cognitive tasks will increase as the participants improve in their performance. Receives: Behavioral: Cognitive training; Behavioral: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Montreal Cognitive Assessment (MoCA)
The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of 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 (an expected average of 3 months), follow-up (up to 9 months)
Change scores of 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 (an expected average of 3 months), follow-up (up to 9 months)
Change scores of 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 (Blankevoort, van Heuvelen, \& Scherder, 2013).
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary outcomes (17)
Change scores of the Verbal Fluency Test
Verbal fluency tests will be used to evaluate the semantic memory of the participants. The participants will be instructed to say as many words as possible from a given category (i.e., fruit or animal) in 1 minute. The validity, reliability, and normative performance of verbal fluency tests have been well-established (Harrison, Buxton, Husain, \& Wise, 2000).
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Useful Field of View (UFOV)
Useful field of view (UFOV) is the visual area over which useful information could be obtained at a quick glance without eye or head movements. This UFOV will be assessed with the BrainHQ program. The UFOV will assess the abilities of visuomotor processing speed, divided attention, and selective attention (Ball, Edwards, \& Ross, 2007).
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the 30 second chair stand test (CST)
The 30 second chair stand test (CST) 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 CST in people with cognitive impairment have been established to be good (Blankevoort et al., 2013).
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Chinese version of the 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 (Craig et al., 2003).
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Barthel Index (BI)
Assess activities of daily living
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Lawton Instrumental Activities of Daily Living Scale
Assess activities of daily living.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Disability Assessment for Dementia (DAD)
Assess activities of daily living.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD)
The Chinese version of QoLAD will be used.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Caregiver Burden Inventory (CBI)
The Chinese version of CBI will be used.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Geriatric Depression Scale (GDS)
The Chinese version of short form GDS will be used.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Community Integration Questionnaire (CIQ)
The CIQ measures items relevant to home integration, social integration, and productive activities.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the ActiGraph GX3 accelerometers Change scores of the ActiGraph
The actigraphy will be placed on the waist for a 3-day period immediately before and after the intervention. The participants will wear the actigraphy during all daily activities except for those that involve water (i.e., showering or swimming).
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of evaluating isometric knee flexors and extensors muscle strength
The participant will be seated upright in a chair with back support, the knee will be placed in 90-degree flexion and the evaluator will stabilize the thing to eliminate synergistic movements. Participants will be asked to perform a maximal isometric contraction of knee flexion and extension with both lower extremities. The investigators will record the mean value of 3 attempts.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of using hand dynamometer to measure grip strength of both hand
The participant is seated, with the elbow at 90-degree flexion. The investigators will record the mean value of 3 attempts.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
The investigators will use the WMS-III subtests, including Faces Recognition (score range 0-48), Verbal Paired Associates (score range 0-32), Word Lists (0-48), and Spatial Span (0-32) to assess the immediate, delayed, and working memory tests. Higher scores indicated better performance for each subtest. The raw score of each subtest will also be transferred to standardized Z scores and summed to represent an index of general memory function.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
The WAIS-III includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed. The subtests that the investigators will use are the Digit Symbol-Coding (scores range 0-133) and Matrix Reasoning tests (0-26). The raw score of each subtest will also be transferred to standardized Z scores and summed to represent an index of general cognitive function.
Measured: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
BDNF val66met genotype
Saliva samples will be collected at baseline to determine the Brain-Derived Neurotrophic Factor (BDNF) val66met genotype.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start30 Jan 2015
- Primary completion29 Jan 2018
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
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
- NCT02512627
- Sponsor's protocol ID
- 103-6651A3
- Status last verified
- May 2019
- First submitted
- 20 Jul 2015
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee YY, Wu CY, Teng CH, Hsu WC, Chang KC, Chen P. Evolving methods to combine cognitive and physical training for individuals with mild cognitive impairment: study protocol for a randomized controlled study. Trials. 2016 Oct 28;17(1):526. doi: 10.1186/s13063-016-1650-4.
PubMed 27793183
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
- ClinicalTrials.gov ID
- NCT02512627
- Acronym / sponsor ID
- 103-6651A3
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, exercise, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 30 Jan 2015 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.
Detailed description
Background and study aims:
Mild cognitive impairment (MCI) or minor neurocognitive disorder is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The age-adjusted prevalence of MCI in Taiwan is approximately 18%, while women have higher prevalence for MCI than men. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in 5 years. Therefore, early detection of the individuals who manifest MCI and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Previous studies found that cognitive training or exercise has emerged as an important therapeutic approach for individuals with MCI. However, the intervention effects of combining exercise and cognitive training remain to be determined. Furthermore, whether exercise and cognitive training should be administered in sequential order or simultaneously is an important question to pursue. The overall goal of this study is to determine and compare the intervention effects cognitive training, exercise, and combining cognitive and exercise training in individuals with MCI.
Who can participate? Individuals with MCI.
What does the study involve? The participants will receive a total of 36 training sessions, and each session will contain 90 minutes of training. Training frequency will be 2-3 times per week for 12-18 weeks. All participants will received pretreatment test, post treatment test, and a 6-month follow-up test.
What are the possible benefits and risks of participating? The possible benefits include improvement in cognitive, physical, and daily functions. There are no risks for participating.
Where to conduct the study? The investigators anticipate recruiting a total of 80 participants from geriatric day care centers and nursing homes from multiple cities in Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive training group (Cog) | Active comparator | Behavioral: Cognitive trainingThe BrainHQ program will be used to train different cognitive functions of the participants. The participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions. The tasks will become more difficult as the participants progress in their abilities. |
| Physical exercise group (PE) | Active comparator | Behavioral: Physical exerciseThe participants in this group participate in multimodal exercise programs including aerobic exercise, balance, and strength training. The entire exercise program for the PE group will contain 10 minutes of warm-up, 70 minutes of physical exercise, and 10 minutes of cool-down. The 70 minutes of exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period. |
| Sequential training group (Seq) | Experimental | Behavioral: Cognitive training, Behavioral: Physical exerciseThe participants in this group will first perform 45 minutes of physical exercise followed by 45 minutes of cognitive training. The physical exercise training will be similar to the programs used in the PE group. The entire exercise program for the PE group will contain 5 minutes of warm-up, 35 minutes of physical exercise, and 5 minutes of cool-down. The cognitive training will be implemented with BrainHQ similar to what has been described in the COG group. |
| Dual-task training group (Dual) | Experimental | Behavioral: Cognitive training, Behavioral: Physical exerciseIn this group, the participants will be instructed to perform physical exercise and cognitive tasks simultaneously (e.g., math calculation while stepping). The difficulty of the cognitive tasks will increase as the participants improve in their performance. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- able to follow instruction,
- clinical dementia rating (CDR) = 0.5 or 1,
- self- or informant-reported memory or cognitive complaint, and
- able to perform activities of daily living (Barthel Index ≥ 70).
Key exclusion criteria (6 listed)
- recent myocardial infarction,
- heart failure,
- recent heart surgery,
- severe asthma,
- concomitant with other neurological disorders, or
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 |
|---|---|---|
| Cognitive trainingvisuospatial, attention, memory, and executive abilities | Behavioural | Cognitive training group (Cog), Dual-task training group (Dual), Sequential training group (Seq) |
| Physical exerciseendurance, balance, and mobility | Behavioural | Dual-task training group (Dual), Physical exercise group (PE), Sequential training group (Seq) |
Primary outcome
Change scores of Montreal Cognitive Assessment (MoCA)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30.
Change scores of Stroop test
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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 Dual-task test
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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 Timed up and go (TUG) test
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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 (Blankevoort, van Heuvelen, \& Scherder, 2013).
17 secondary outcomes
Change scores of the Verbal Fluency Test
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Useful Field of View (UFOV)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the 30 second chair stand test (CST)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Chinese version of the International Physical Activity Questionnaires (IPAQ)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Barthel Index (BI)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Lawton Instrumental Activities of Daily Living Scale
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Disability Assessment for Dementia (DAD)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Caregiver Burden Inventory (CBI)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Geriatric Depression Scale (GDS)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Community Integration Questionnaire (CIQ)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the ActiGraph GX3 accelerometers Change scores of the ActiGraph
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of evaluating isometric knee flexors and extensors muscle strength
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of using hand dynamometer to measure grip strength of both hand
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
BDNF val66met genotype
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Derived from this study: PubMed 27793183Lee YY, Wu CY, Teng CH, Hsu WC, Chang KC, Chen P. Evolving methods to combine cognitive and physical training for individuals with mild cognitive impairment: study protocol for a randomized controlled study. Trials. 2016 Oct 28;17(1):526. doi: 10.1186/s13063-016-1650-4.
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Physical exercise in people with Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 9 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Montreal Cognitive Assessment (MoCA) (time frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)). 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?
On the ClinicalTrials.gov record for NCT02512627, which also lists 1 linked publication.
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 12 Jul 2019.