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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:
Older adults will be asked to participate in a group training session that was lead by a fitness coach using a pressure sensor mat, a standing monitor, and a linked software programs. They will be asked to stand on the mat, which is set in front of a monitor to show positions of the mat where they place their foots. The monitor screen will guide them to conduct either a balancing exercise for fall prevention or a cognitive exercise such as memory game or quiz game for dementia prevention.
Researchers will compare age and gender matched control group in a main study to see if cognitive and balancing functions of intervention group is better than the control group by conducting pre and post surveys and physical examinations. A pilot study will examine pre-post changes in the intervention group without the control group.
A. Developed group exercise devices
â—‹ The study will test the flexible, stretchable film-type pressure sensor embedded balance mat and a monitor that will present a sequence of fitness programs and cognitive tasks.
B. Pilot Test
C. The main test
The main test will be conducted with single-blind, randomized controlled trial (RCT) design. The intervention group will participate in the group exercises using the developed devices that are led by a trainer.
Pre-, mid-, and post-assessment: Measurements will be taken three times-before the intervention, after 8 weeks of exercise, and after 16 weeks of exercise-assessing balance, physical fitness, cognition, depression, sleep, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | Older adults who participated only in the pre-post tests without receiving any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Geriatic depression | Geriatric depression scale score ranges from 0-15 with higher scores indicating more severe depressive symptoms. | Geriatric depression scale will be conducted at baseline and within one week following the last session of the intervention. |
| Pain related functional limitations |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Test | System usability test will be conducted to examine changes in the levels of usability for the digital devices that were developed for the intervention program. | The system usability test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunmi Song, PhD | Contact | 821087489593 | sunmi.song0715@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Junesun Kim, PT/PhD | Korea University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University | Recruiting | Seoul | Seoul | 02841 | South Korea |
The IRB approval of this study do not allow sharing data from this study with other researchers.
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D000058 | Accidental Falls |
| ID | Term |
|---|---|
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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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.
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Outcome assessors will be research assistants who do not know the group assignment of participants.
|
| 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. |
The brief version of the Western Ontario and McMaster Universities Osteoarthritis Index, which measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68), with higher scores indicating worse pain and functional limitations in one's daily living. |
| 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 brief version of the Pittsburgh Sleep Quality Index ranges from 0 to 15 with higher score indicating more sleep problems. | 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 Morse Fall Risk Scale ranges 0-125 with higher score indicating higher risk of fall. | 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 | WHO quality of life bref assesses physical, psychological, social, environmental health, which ranges 7-35, 6-30, 3-15, 8-40, respectively, higher score indicating better physical, psychological, social, environmental health status. | The system usability test will be conducted at baseline and within one week following the last session of the intervention. |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |