NCT06542601

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 7, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

August 4, 2024

Last Update Submit

August 4, 2024

Conditions

Keywords

Motoric Cognitive RiskCognitive trainingExercise training

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Total

All subjects

Device: Motor cognitive intervention

Interventions

Older adults were given cognitive training and motor training for 12 weeks using a tablet computer

Total

Eligibility Criteria

Age60 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly people with Motoric Cognitive Risk living in Beijing community

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Study Officials

  • Yi Tang, MD., PhD.

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Tang, MD., PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 7, 2024

Study Start

July 4, 2024

Primary Completion

January 30, 2025

Study Completion

June 30, 2025

Last Updated

August 7, 2024

Record last verified: 2024-04

Locations