Disability PhysicalNCT06542601
Combined Motor and Cognitive Training for Older Adults With Motoric Cognitive Risk Syndrome (CMC-training)
An observational study of Disability Physical and Disabilities Mental, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
To investigate the effects of a combined motor-cognitive intervention on the improvement of motor as well as cognitive function in community residents. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Disability Physical, Disabilities Mental, Age Problem
- What is being tested?
- Motor cognitive intervention
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2024to 30 Jun 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly people with Motoric Cognitive Risk living in Beijing community
Who may be able to join
- Age 60-80 years; ≥ 9 years of education; Cognitive impairment: MMSE score 22-26; Slow gait:total walking time >4 seconds and ≤8 seconds in a 4-meter walk test; Agreed to participate in the study and signed an informed consent form.
Who cannot join
- Dementia/suspected dementia; Suffering from diseases that affect cognitive function, such as cerebrovascular disease, Parkinson's syndrome, etc.; Taking medications related to cognitive improvement and psychiatric disorders, etc.; Recent heart attack, severe cerebrovascular disease, psychiatric disorders, etc.; other inability to persist in completing exercise cognitive interventions, such as suffering from severe musculoskeletal disorders; Participating in another clinical trial at the same time； Participation in an exercise and/or cognitive intervention in the past 6 months; Inability to complete content in studies such as neuropsychological scale assessments.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Yi Tang, M.D., Ph.D., 00861083199456
About this study
Official title: Effect of Combined Motor and Cognitive Training on Older Adults With Motoric Cognitive Risk Syndrome in Community: a Randomized Controlled Study
To investigate the effects of a combined motor-cognitive intervention on the improvement of motor as well as cognitive function in community residents.
Read the detailed description
Cognitive training uses systematically designed tasks that are difficulty-adaptive for cognitive domains such as attention, memory, and logical reasoning to improve individual cognitive functioning. Internet-based Adaptive Multi-Cognitive Domain Cognitive Training is conducted 3 times per week for 30 minutes each time, and includes tasks such as delayed memory, paired memory, and inverse numerical breadth.
The exercise intervention was based on the M-Mobile multicomponent exercise program, in which older adults were instructed to complete exercise training at home at least three days per week. In all intervention groups, balance, sitting test and walking speed were assessed according to the Simple Physical Performance Battery (SPPB), and according to their scores, they were given exercise training, including flexibility, balance, aerobic training and resistance training.
- Conditions
- Disability Physical, Disabilities Mental, Age Problem
- Being tested
- Motor cognitive intervention
- Keywords
- Motoric Cognitive Risk, Cognitive training, Exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor cognitive interventionDevice
Older adults were given cognitive training and motor training for 12 weeks using a tablet computer
| Study group | Role | What they receive |
|---|---|---|
| Total | All subjects Receives: Device: Motor cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function changes in the intervention group and the control group
Changes in Montreal Cognitive Assessment Scale (MoCA) scores before and after intervention between the two groups
Measured: 12 weeks
Motor function changes in the intervention group and the control group
Changes in Montreal Short Physical performance Battery (SPPB) scores before and after intervention between the two groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start4 Jul 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Tang, MD., PhD., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542601
- Sponsor's protocol ID
- 2022-234
- Status last verified
- Apr 2024
- First submitted
- 4 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Motor and Cognitive Training on Older Adults With Motoric Cognitive Risk Syndrome in Community: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06542601
- Acronym / sponsor ID
- 2022-234
- Conditions
- Disability Physical, Disabilities Mental, Age Problem
- Keywords
- Motoric Cognitive Risk, Cognitive training, Exercise training
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Aug 2024 (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.
To investigate the effects of a combined motor-cognitive intervention on the improvement of motor as well as cognitive function in community residents.
Detailed description
Cognitive training uses systematically designed tasks that are difficulty-adaptive for cognitive domains such as attention, memory, and logical reasoning to improve individual cognitive functioning. Internet-based Adaptive Multi-Cognitive Domain Cognitive Training is conducted 3 times per week for 30 minutes each time, and includes tasks such as delayed memory, paired memory, and inverse numerical breadth.
The exercise intervention was based on the M-Mobile multicomponent exercise program, in which older adults were instructed to complete exercise training at home at least three days per week. In all intervention groups, balance, sitting test and walking speed were assessed according to the Simple Physical Performance Battery (SPPB), and according to their scores, they were given exercise training, including flexibility, balance, aerobic training and resistance training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total | – | Device: Motor cognitive interventionAll subjects |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly people with Motoric Cognitive Risk living in Beijing community
Key inclusion criteria (1 listed)
- Age 60-80 years; ≥ 9 years of education; Cognitive impairment: MMSE score 22-26; Slow gait:total walking time >4 seconds and ≤8 seconds in a 4-meter walk test; Agreed to participate in the study and signed an informed consent form.
Key exclusion criteria (1 listed)
- Dementia/suspected dementia; Suffering from diseases that affect cognitive function, such as cerebrovascular disease, Parkinson's syndrome, etc.; Taking medications related to cognitive improvement and psychiatric disorders, etc.; Recent heart attack, severe cerebrovascular disease, psychiatric disorders, etc.; other inability to persist in completing exercise cognitive interventions, such as suffering from severe musculoskeletal disorders; Participating in another clinical trial at the same time； Participation in an exercise and/or cognitive intervention in the past 6 months; Inability to complete content in studies such as neuropsychological scale assessments.
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 |
|---|---|---|
| Motor cognitive interventionOlder adults were given cognitive training and motor training for 12 weeks using a tablet computer | Device | Total |
Primary outcome
Cognitive function changes in the intervention group and the control group
Time frame: 12 weeks
Changes in Montreal Cognitive Assessment Scale (MoCA) scores before and after intervention between the two groups
Motor function changes in the intervention group and the control group
Time frame: 12 weeks
Changes in Montreal Short Physical performance Battery (SPPB) scores before and after intervention between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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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.
Yi Tang, MD., PhD. principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability Physical and Disabilities Mental, run by Xuanwu Hospital, Beijing at 1 site in China.
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 1 inclusion and 1 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 7 Aug 2024. 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 China. 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 Yi Tang, MD., PhD. (00861083199456, tangyi@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function changes in the intervention group and the control group (time frame: 12 weeks). The study lists 2 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 7 Aug 2024.