Combined Motor and Cognitive Training for Older Adults Wi... | NCT06542601

Studies
Combined Motor and Cognitive Training for Older Adults With Motoric Cognitive Risk Syndrome (CMC-training)

NCT06542601

Sponsor

Xuanwu Hospital, Beijing

Status

Unknown status

Last Update Posted

Aug 7, 2024Actual

Enrollment

204Estimated

Phase

Not provided

Conditions

Disability Physical
Disabilities Mental
Age Problem

Interventions

Motor cognitive intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2024Actual

Primary Completion Date

Jan 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Aug 4, 2024

First Submission Date that Met QC Criteria

Aug 4, 2024

First Posted Date

Aug 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2024

Last Update Posted Date

Aug 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

204Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total		All subjects	Device: Motor cognitive intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motor cognitive intervention	Device	Older adults were given cognitive training and motor training for 12 weeks using a tablet computer	Total

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

All

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Elderly people with Motoric Cognitive Risk living in Beijing community

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Tang, MD., PhD.	Contact	00861083199456		tangyi@xwhosp.org

Overall Officials

Name	Affiliation	Role
Yi Tang, MD., PhD.	Xuanwu Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu Hospital, Capital Medical University	Recruiting	Beijing		100053	China