Development of Pressure Sensor Based Dementia and Fall Prevention Program for Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSunmi Song
About this trial
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. 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. 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.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Older adults in the community who are 65 years old or older.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Fall and dementia prevention exercise
BehavioralThe 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.
Treatment groups
205 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
The system usability test will be conducted at baseline and within one week following the last session of the intervention.2
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.
Time frame
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).3
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
Time frame
The test will be conducted at baseline, and at the mid-term assessment, and within one week following the last session of the intervention.4
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.
Time frame
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.Secondary outcomes
1
Geriatic depression
Geriatric depression scale score ranges from 0-15 with higher scores indicating more severe depressive symptoms.
Time frame
Geriatric depression scale will be conducted at baseline and within one week following the last session of the intervention.2
Pain related functional limitations
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.
Time frame
The WOMAC will be conducted at baseline and within one week following the last session of the intervention.3
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.
Time frame
The PSQI will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.4
The Morse Fall Risk Scale
The Morse Fall Risk Scale ranges 0-125 with higher score indicating higher risk of fall.
Time frame
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
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.
Time frame
The system usability test will be conducted at baseline, mid-term survey, and within one week following the last session of the intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sunmi Song
Lead sponsor
Korea University
Sponsor institution
Source ClinicalTrials.gov