Development of Pressure Sensor Based Dementia and Fall Prevention Program for Older Adults

NCT06664229 | Recruiting

• 1 other identifier: Q2317781
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention program is to test the effectiveness of pressure sensor based dementia and fall prevention program for improving cognitive and physical functions of community dwelling older adults. The main purposes of this study are:

1. 1.Develop a pressure sensor based exercise mat and linked software programs to be used for group training sessions for cognitive and balance training of older adults at a community senior center.
2. 2.Evaluate efficacy of the program to improve cognitive and physical functions of older adults via a pilot study and a main study with randomized control trial design.

Conditions

Dementia, Mild; Accidental Falls; Mild Cognitive Impairment

Keywords

Fall prevention; Dementia prevention; Mild cognitive impairment; Exercise game; Cognitive training game; Community based intervention; Older adults

Outcome Measures

Primary Outcomes (9)

• The Mini-Mental State Exam Korean Version (MMSE-K)

  The Mini-Mental State Exam Korean version (MMSE-K) ranges from 0-30 with higher score indicating better cognitive function.

  The system usability test will be conducted at baseline and within one week following the last session of the intervention.

• The Berg Balance test

  The Berg Balance test (Lusardi, 2004) ranges from 0 to 56 with lower score indicating the more risk of losing one's balance.

  The Berg balance test will be conducted at baseline (one week before the first session), mid-term survey (6th week of 12 week program or 8th week of 16 week program), and within one week following the last session of the intervention (13th or 17th week).

• Sarcopenia index

  Sarcopenia-related measures, including appendicular skeletal muscle mass (ASM), appendicular skeletal muscle mass index (ASMI), and handgrip strength, were assessed according to the Asian Working Group for Sarcopenia 2019 criteria

  The test will be conducted at baseline, and at the mid-term assessment, and within one week following the last session of the intervention.

• The figure of 8 walk test

  The figure of 8 walk test measures the time (seconds) to walk a figure-of-eight around 2 cones placed 2.4 m apart twice. The smaller score indicates the better walking ability of a participant.

  The figure of 8 walk test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.

• The 3 m sit-walk and return test

  The 3 m sit-walk and return test measures the time (seconds) from sitting on a chair to standing, walking to a 3 m target, and then returning to the chair and sitting down. The shorter test score indicates better fitness of a participant.

  The 3 m sit-walk and return test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.

• The 30 second sit-stand test

  The 30 second sit-stand test measures the number of completed chair stands in 30 seconds. The larger number of completed chair stands, the better physical fitness of a participant.

  The 30 second sit-stand test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.

• Montreal Cognitive Assessment (MoCA)

  MoCA test will be conducted to examine changes in cognitive functioning before and after the intervention program in addition to MMSE.

  MoCA will be conducted at baseline and within one week following the last session of the intervention.

• The 2 minute step in place test

  The 2 minute step in place test (number): A test that measures the total number of times the right knee reaches the tape level in two minutes. The more number of reaches, the better fitness scores the participant has.

  The 2 minute step in place test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.

• The sit and reach test (cm)

  The sit and reach test (cm) measures the distance reached by the hand. The participant sits on the floor with legs stretched out straight ahead, with the soles of the feet flat against the box. Both knees should be locked and pressed flat to the floor. Reach forward with a slow and steady movement as far as possible, and hold that position for three seconds while the distance is recorded. The larger scores indicate the better fitness of the participant.

  The sit and reach test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.

Secondary Outcomes (5)

• Geriatic depression

  Geriatric depression scale will be conducted at baseline and within one week following the last session of the intervention.

• Pain related functional limitations

  The WOMAC will be conducted at baseline and within one week following the last session of the intervention.

• The Pittsburgh Sleep Quality Index (PSQI)

  The PSQI will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.

• The Morse Fall Risk Scale

  The system usability test will be conducted at baseline and within one week following the last session of the intervention.

• WHO quality of life bref

  The system usability test will be conducted at baseline and within one week following the last session of the intervention.

Other Outcomes (1)

• System Usability Test

  The system usability test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

Older adults who participated in a group exercise program using the developed mat and software three times per week for six weeks (18 sessions) for a pilot study and twelve weeks (36 sessions) for a main study took part in the pre-post tests. The frequency and duration can be adjusted to twice per week for nine weeks (18 sessions) for a pilot study or twice per week for sixteen weeks (32 sessions) for a main study to accommodate the availability of participants and the spaces in the community center.

Behavioral: Fall and dementia prevention exercise

Control group

NO INTERVENTION

Older adults who participated only in the pre-post tests without receiving any intervention.

Interventions

Fall and dementia prevention exercise BEHAVIORAL

The fall and dementia prevention exercise is designed as a combination of balancing and cognitive exercise and games that is conducted as a group activity. The session will be provided three times per week for six weeks for a pilot test and three times per week for 12 weeks for a main comparison study. The fall prevention exercise involves the pressure mat based balancing exercise such as side stepping, heel or toe standing, and quarter squat. The safety bar will be placed around the mat, so that older adults with instability can hold while they follow the movements. The cognitive exercise will concise of multiple types of cognitive tasks to train memory, numeric processing, spatial perception, and logical thinking. For example, memory task such as memorizing the series of positions on the screen and use the mat to point the positions in the right order. At the end, older adults play games in which they use balancing movements and cognitive tasks to gain scores for their team.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Older adults in the community who are 65 years old or older.

You may not qualify if:

• Older adults who cannot walk independently with assisting devices or use wheelchair.
• Older adults who are diagnosed with dementia, or other neurological/mental disorders that may limit their cognitive ability to participate in the study.
• Older adults who cannot speak or read Korean.

Sponsors & Collaborators

• Sunmi Song: lead

Study Sites (1)

Korea University

Seoul, Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular; Cognitive Dysfunction

Interventions

Accidental Falls

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cognition Disorders

Intervention Hierarchy (Ancestors)

Accidents; Public Health; Environment and Public Health

Study Officials

• Junesun Kim, PT/PhD

  Korea University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunmi Song, PhD

CONTACT

821087489593; sunmi.song0715@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be research assistants who do not know the group assignment of participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Model Details: We will conduct a single-blind randomized control trial design for the main study. The pilot study will have the intervention group only without the control group.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: October 29, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)