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Effects of Wearable Sensor-based Interactive Cognitive-motor Training in Older Adults.

Primary Purpose

Cognitive Decline, Mild, Cognition Disorders in Old Age, Subjective Memory Decline

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cognitive-motor training
cognition training
Sponsored by
Sahmyook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Decline, Mild focused on measuring cognitive-motor training, cogntion, physical function, older adults, interactive system, wearable sensor

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Community-dwelling seniors age 65 and older MMSE-K 18 or less Exclusion Criteria: 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

Sites / Locations

  • Mapo senior welfare center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

cognitive-motor training group

cognition training group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Change in Aerobic capacity
Aerobic capacity is measured using the 6-minute walk test (6MWT). The 6MWT measures the distance a subject can walk in six minutes. You can take as many breaks as you like and the examiner can provide a chair. The examiner records the distance you walk in six minutes, the number of breaks you take, and the duration of the breaks.
Change in dynamic balance function 1
The Four Square Step Test (FSST) is used to assess dynamic balance ability. The FSST consists of stepping safely and as quickly as possible, without touching the sticks, over four sticks placed in a criss-cross configuration on the floor, and is scored by recording the time in seconds.
Change in dynamic balance function 2
Dynamic balance is assessed using the Functional Reach Test (FRT). The FRT measures the distance (in centimeters) that the head of the third metacarpal of the hand moves by extending the arm forward without moving the foot from a standing position.
Change in static balance function
To assess static balance, using the Single Leg Stance Test (SLS). The SLS measures the number of seconds standing on one leg with hands on hips and eyes open.
Change in upper extremity strengthen
Upper extremity strength is assessed with the arm curl test. On women perform a biceps curl with a 2.3 kg dumbbell and men with a 3.6 kg dumbbell. They are seated in a chair with no armrests or backrest. Scoring is based on the number of repetitions performed in 30 seconds.
Change in grip strengthen
Grip strength is measured using a dynamometer and the subject is seated in a chair with arms extended, natural rotation, elbow flexed 90 degrees, forearm at natural angle and wrist in dorsiflexion between 0 and 30 degrees. The subject is then asked to grip the dynamometer for 3 seconds and the average value (kg) over 3 trials is recorded.
Change in lower extremity strengthen
Lower extremity strength is assessed using the 5 sit to stand test (5xSST). The 5xSST measures the number of seconds a subject can go from sitting to standing and back to sitting five times, with the shorter the time, the better the strength.
Change in Instrumental Activity of Daily Living(IADLs)
IADLs require higher cognitive skills than basic activities of daily living, and IADLs can detect functional changes in the early stages of dementia. Instrumental IADLs are assessed using the Functional Activities Questionnaire (FAQ). The FAQ can differentiate between Mild cognitive impairment(MCI) and mild Alzheimer's disease(AD).

Full Information

First Posted
July 20, 2023
Last Updated
October 24, 2023
Sponsor
Sahmyook University
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1. Study Identification

Unique Protocol Identification Number
NCT05983913
Brief Title
Effects of Wearable Sensor-based Interactive Cognitive-motor Training in Older Adults.
Official Title
Effects of Cognitive-motor Training Using a Wearable Sensor-based Interactive System on Cognitive and Motor Performance in Older Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Actual)
Study Completion Date
October 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The proposed study will conduct a randomized controlled trial to compare the effects of a cognitive-motor training program using a wearable sensor-based interactive system on the cognitive and physical abilities of older adults in the community. Study participants will be randomly assigned to receive one of two interventions: (a) motor-cognitive training (b) cognitive training. All interventions will last 50 minutes and will be delivered twice a week for 6 weeks. To determine the effectiveness of the interventions, the primary outcome will assess PFC activity and cognition, and the secondary outcome will assess aerobic capacity, balance, upper extremity muscle strength, lower extremity muscle strength, and instrumental activities of daily living tasks. All assessments will be administered one week before and one week after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Mild, Cognition Disorders in Old Age, Subjective Memory Decline
Keywords
cognitive-motor training, cogntion, physical function, older adults, interactive system, wearable sensor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel-group randomized study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive-motor training group
Arm Type
Experimental
Arm Description
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.
Arm Title
cognition training group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cognitive-motor training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cognition training
Intervention Description
The intervention consists of five cognitive tasks (memory, attention, spatial and temporal perception) with difficulty levels adapted to the individual's cognitive abilities.
Primary Outcome Measure Information:
Title
Change in prefrontal cortex activation
Description
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.
Time Frame
change from baseline to 6 week post intervention
Title
Change in cognition
Description
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.
Time Frame
change from baseline to 6 week post intervention
Secondary Outcome Measure Information:
Title
Change in Aerobic capacity
Description
Aerobic capacity is measured using the 6-minute walk test (6MWT). The 6MWT measures the distance a subject can walk in six minutes. You can take as many breaks as you like and the examiner can provide a chair. The examiner records the distance you walk in six minutes, the number of breaks you take, and the duration of the breaks.
Time Frame
change from baseline to 6 week post intervention
Title
Change in dynamic balance function 1
Description
The Four Square Step Test (FSST) is used to assess dynamic balance ability. The FSST consists of stepping safely and as quickly as possible, without touching the sticks, over four sticks placed in a criss-cross configuration on the floor, and is scored by recording the time in seconds.
Time Frame
change from baseline to 6 week post intervention
Title
Change in dynamic balance function 2
Description
Dynamic balance is assessed using the Functional Reach Test (FRT). The FRT measures the distance (in centimeters) that the head of the third metacarpal of the hand moves by extending the arm forward without moving the foot from a standing position.
Time Frame
change from baseline to 6 week post intervention
Title
Change in static balance function
Description
To assess static balance, using the Single Leg Stance Test (SLS). The SLS measures the number of seconds standing on one leg with hands on hips and eyes open.
Time Frame
change from baseline to 6 week post intervention
Title
Change in upper extremity strengthen
Description
Upper extremity strength is assessed with the arm curl test. On women perform a biceps curl with a 2.3 kg dumbbell and men with a 3.6 kg dumbbell. They are seated in a chair with no armrests or backrest. Scoring is based on the number of repetitions performed in 30 seconds.
Time Frame
change from baseline to 6 week post intervention
Title
Change in grip strengthen
Description
Grip strength is measured using a dynamometer and the subject is seated in a chair with arms extended, natural rotation, elbow flexed 90 degrees, forearm at natural angle and wrist in dorsiflexion between 0 and 30 degrees. The subject is then asked to grip the dynamometer for 3 seconds and the average value (kg) over 3 trials is recorded.
Time Frame
change from baseline to 6 week post intervention
Title
Change in lower extremity strengthen
Description
Lower extremity strength is assessed using the 5 sit to stand test (5xSST). The 5xSST measures the number of seconds a subject can go from sitting to standing and back to sitting five times, with the shorter the time, the better the strength.
Time Frame
change from baseline to 6 week post intervention
Title
Change in Instrumental Activity of Daily Living(IADLs)
Description
IADLs require higher cognitive skills than basic activities of daily living, and IADLs can detect functional changes in the early stages of dementia. Instrumental IADLs are assessed using the Functional Activities Questionnaire (FAQ). The FAQ can differentiate between Mild cognitive impairment(MCI) and mild Alzheimer's disease(AD).
Time Frame
change from baseline to 6 week post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Community-dwelling seniors age 65 and older MMSE-K 18 or less Exclusion Criteria: 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
Facility Information:
Facility Name
Mapo senior welfare center
City
Seoul
ZIP/Postal Code
04099
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Wearable Sensor-based Interactive Cognitive-motor Training in Older Adults.

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