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

Cognition Disorders in Old Age Clinical Trial

Official title:

Effects of Cognitive-motor Training Using a Wearable Sensor-based Interactive System on Cognitive and Motor Performance in Older Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05983913
• Other study ID #: SYU 2023-06-020-001
• Status: Completed
• Phase: N/A
• Start date: August 26, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: October 2023
• Source: Sahmyook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognition Disorders in Old Age
• Cognitive Dysfunction

Intervention

Behavioral:
• cognitive-motor training
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.
• cognition training
The intervention consists of five cognitive tasks (memory, attention, spatial and temporal perception) with difficulty levels adapted to the individual's cognitive abilities.

Locations

Country	Name	City	State
Korea, Republic of	Mapo senior welfare center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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 from baseline to 6 week post intervention
Secondary	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 from baseline to 6 week post intervention
Secondary	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 from baseline to 6 week post intervention
Secondary	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 from baseline to 6 week post intervention
Secondary	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 from baseline to 6 week post intervention
Secondary	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 from baseline to 6 week post intervention
Secondary	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 from baseline to 6 week post intervention
Secondary	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).	change from baseline to 6 week post intervention