Mild Cognitive ImpairmentNCT03839576
Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment
A study testing Exercise and Computerized training in people with Mild Cognitive Impairment and Fall, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Mild Cognitive Impairment, Fall
- What is being tested?
- Exercise and Computerized training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2017to 24 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- At least 65 years old
- Had a fall at least 3 months prior to the baseline assessment
- Can ambulate independently
- Has mild cognitive impairment
Who cannot join
- Cannot ambulate independently and communicate with researchers
- Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
- Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Chih-Yi Chen, Master, 886-2-27361661 ext. 6572, m513090003@tmu.edu.tw
About this study
A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the influence of adherence to the intervention programs will also be examined.
- Conditions
- Mild Cognitive Impairment, Fall
- Being tested
- Exercise, Computerized training
- Keywords
- gait, computerized cognitive training, falls, mild cognitive impairment, mobility, physical exercise, tai chi chuan
- 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.
ExerciseBehavioural
Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
Computerized trainingBehavioural
Attention, memory, speed of processing, and executive functioning.
| Study group | Role | What they receive |
|---|---|---|
| Computerized cognitive training | Experimental | The computerized cognitive training will take place at each participant's residence. Participants will be asked to practice at least 1 session a day for 6 months, and a session lasts for 60 minutes. Receives: Behavioral: Computerized training |
| Lower extremity strengthening | Experimental | This exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months.
Each session will last 60 min. Receives: Behavioral: Exercise |
| Tai chi chuan | Experimental | The 8-form Yang-style tai chi intervention will take place at a subject's residence or the neighborhood once a week for 6 months, and each session will last for 60 minutes. Receives: Behavioral: Exercise |
| Social interaction | No intervention | Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mattis Dementia Rating Scale (MDRS)
The Mattis Dementia Rating Scale (MDRS) contains five cognitive domains of attention, initiation/perseveration, construction, conceptualization, and memory, which specifically assess concentration, verbal fluency, visuospatial skills, analogical reasoning, and short-term memory, with score ranges for these domains of 0~37, 0~37, 0~6, 0~39, and 0~25 points, respectively, and a total score range of 0~144 points.
Measured: 12 months
modified Telephone Interview of Cognitive Status (TICS-M)
The modified Telephone Interview of Cognitive Status (TICS-M) consists of the date of the interview, age, phone number, immediate and delayed word list recall, counting backward, responsive naming, word opposites, and repetition, with a total score range of 0~50.
Measured: 12 months
mobility
The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.
Measured: 12 months
balance
The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
Measured: 12 months
falls
number of falls and multiple falls
Measured: 12 months
Secondary outcomes (3)
depressive symptoms
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.
Measured: 12 months
fear of falling
Activities-specific Balance Confidence (ABC) scale assesses an individual's confidence in performing 16 common daily tasks without losing balance, and total scores of the ABC scale are determined by the accumulated average of each item score and range between 0 and 100, with lower scores indicating greater balance confidence.
Measured: 12 months
activity of daily living (ADL)
The activity of daily living (ADL) scale consists of seven basic ADLs (self-feeding, self-dressing, grooming, walking, getting in/out of bed, bathing, and controlling the bladder) and seven instrumental ADLs (using a telephone, transporting oneself, shopping, preparing meals, doing housework, taking medication, and managing one's money). These items are graded as 0 points (inability), 1 point (needs some help), or 2 points (no help needed). The ADL score ranges from 0 to 28 points, with a lower score indicating greater activity disability.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start15 Feb 2017
- Primary completion24 Jan 2023 (estimated)
- Study completion24 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Mau-Roung Lin, Professor, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839576
- Sponsor's protocol ID
- MOST106-2314-B-038-046
- Status last verified
- Jan 2022
- First submitted
- 31 Jan 2019
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03839576
- Acronym / sponsor ID
- MOST106-2314-B-038-046
- Conditions
- Mild Cognitive Impairment, Fall
- Keywords
- gait, computerized cognitive training, falls, mild cognitive impairment, mobility, physical exercise, tai chi chuan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 24 Jan 2023 (estimated)
- Study completion
- 24 Jan 2023 (estimated)
- First posted
- 15 Feb 2019 (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.
A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the influence of adherence to the intervention programs will also be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls.
| Arm | Type | Receives |
|---|---|---|
| Computerized cognitive training | Experimental | Behavioral: Computerized trainingThe computerized cognitive training will take place at each participant's residence. Participants will be asked to practice at least 1 session a day for 6 months, and a session lasts for 60 minutes. |
| Lower extremity strengthening | Experimental | Behavioral: ExerciseThis exercise will comprise stretching, muscle strengthening, and balance training at increasing difficulty levels, tailored and supervised by a physical therapist, and will take place at a subject's residence or in the neighborhood once a week for 6 months. Each session will last 60 min. |
| Tai chi chuan | Experimental | Behavioral: ExerciseThe 8-form Yang-style tai chi intervention will take place at a subject's residence or the neighborhood once a week for 6 months, and each session will last for 60 minutes. |
| Social interaction | No intervention | –Immediately after the baseline assessment, the care manager will visit the subject in this group once for comparability with the other two intervention groups. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- At least 65 years old
- Had a fall at least 3 months prior to the baseline assessment
- Can ambulate independently
- Has mild cognitive impairment
Key exclusion criteria (3 listed)
- Cannot ambulate independently and communicate with researchers
- Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
- Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)
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 |
|---|---|---|
| ExerciseEach session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down. | Behavioural | Lower extremity strengthening, Tai chi chuan |
| Computerized trainingAttention, memory, speed of processing, and executive functioning. | Behavioural | Computerized cognitive training |
Primary outcome
Mattis Dementia Rating Scale (MDRS)
Time frame: 12 months
The Mattis Dementia Rating Scale (MDRS) contains five cognitive domains of attention, initiation/perseveration, construction, conceptualization, and memory, which specifically assess concentration, verbal fluency, visuospatial skills, analogical reasoning, and short-term memory, with score ranges for these domains of 0~37, 0~37, 0~6, 0~39, and 0~25 points, respectively, and a total score range of 0~144 points.
modified Telephone Interview of Cognitive Status (TICS-M)
Time frame: 12 months
The modified Telephone Interview of Cognitive Status (TICS-M) consists of the date of the interview, age, phone number, immediate and delayed word list recall, counting backward, responsive naming, word opposites, and repetition, with a total score range of 0~50.
mobility
Time frame: 12 months
The timed up and go test requires subjects to rise from a standard chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. The time to complete the timed up and go will be recorded.
balance
Time frame: 12 months
The Tinetti balance score ranges 0~26, with a higher score indicating a better balance ability.
falls
Time frame: 12 months
number of falls and multiple falls
3 secondary outcomes
depressive symptoms
Time frame: 12 months
fear of falling
Time frame: 12 months
activity of daily living (ADL)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Mau-Roung Lin, Professor principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Computerized training in people with Mild Cognitive Impairment and Fall, run by Taipei Medical University 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 4 inclusion and 3 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 3 Oct 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 Mau-Roung Lin, Professor (886-2-27361661 ext. 6572, mrlin@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mattis Dementia Rating Scale (MDRS) (time frame: 12 months). The study lists 5 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 3 Oct 2022.