NCT05983913

Brief Summary

  • Based on research showing that cognitive-motor training programs help improve cognition in older adults with mild cognitive impairment, this program uses an interactive system to combine cognitive training with exercise.
  • The interactive system consists of wearable sensors and has the advantage of cognitive training without space constraints, and the cognitive training program consists of a total of five developed cognitive training games.
  • The program is expected to improve the cognitive abilities of the elderly and improve their physical abilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

August 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

July 20, 2023

Last Update Submit

October 24, 2023

Conditions

Keywords

cognitive-motor trainingcogntionphysical functionolder adultsinteractive systemwearable sensor

Outcome Measures

Primary Outcomes (2)

  • Change in prefrontal cortex activation

    Activation of the prefrontal cortex will be assessed by changes in HbO, and differences in PFC activity will be identified during cognitive tasks (memory, attention, and visuospatial cognition) before and after the assessment.

    change from baseline to 6 week post intervention

  • Change in cognition

    For cognitive assessment, we will use the Montreal Cognitive Assessment (MoCA). The MoCA is a cognitive assessment tool used to identify MCI that assesses multiple cognitive domains, including memory, attention, language, visuospatial skills, executive function, and orientation to time and place.

    change from baseline to 6 week post intervention

Secondary Outcomes (8)

  • Change in Aerobic capacity

    change from baseline to 6 week post intervention

  • Change in dynamic balance function 1

    change from baseline to 6 week post intervention

  • Change in dynamic balance function 2

    change from baseline to 6 week post intervention

  • Change in static balance function

    change from baseline to 6 week post intervention

  • Change in upper extremity strengthen

    change from baseline to 6 week post intervention

  • +3 more secondary outcomes

Study Arms (2)

cognitive-motor training group

EXPERIMENTAL

Participants will receive 50 minutes of cognitive-motor training twice per week for 6 weeks. The cognitive-motor training program uses a wearable sensor-based interactive system to perform cognitive tasks in a large space without the constraints of physical movement. Participants wear a wearable sensor-based device on their dominant arm or leg and use an interactive system to perform cognitive-motor tasks.

Behavioral: cognitive-motor training

cognition training group

EXPERIMENTAL

Participants will receive 50 minutes of cognitive training twice a week for 6 weeks. The cognitive training program will be delivered in booklet form, and participants will perform the cognitive tasks of the cognitive-motor training in a seated position with no physical movement.

Behavioral: cognition training

Interventions

The cognitive-motor training program consists of five cognitive tasks related to concentration, reaction time, and executive function, combined with physical exercises using an interactive system. The five tasks include: (1) number sequence, (2) number-word sequence, (3) card matching games, (4) memorizing numbers, and (5) route-finding games.

cognitive-motor training group

The intervention consists of five cognitive tasks (memory, attention, spatial and temporal perception) with difficulty levels adapted to the individual's cognitive abilities.

cognition training group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling seniors age 65 and older
  • MMSE-K 18 or less

You may not qualify if:

  • People of Hospitalized or institutionalized
  • People diagnosed with Alzheimer's disease
  • People diagnosed with vascular dementia
  • People with musculoskeletal conditions that make physical activity difficult
  • People with dizziness that makes physical activity difficult
  • People with a wound or bleeding in the head

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mapo senior welfare center

Seoul, 04099, South Korea

Location

MeSH Terms

Conditions

Cognitive DysfunctionLymphoma, Follicular

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, parallel-group randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 9, 2023

Study Start

August 26, 2023

Primary Completion

October 15, 2023

Study Completion

October 15, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations