Clinical Trial Finder

Inclusion Criteria:

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

Exclusion Criteria:

• - 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.

A. Developed group exercise devices.○ 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.

• - A 65cm wide balance mat embedded with pressure sensors will be utilized for balance trainings and responding to cognitive tasks.

• - The devices are consisted of hardware and software based on a thin, flexible pressure sensor (includes additional safety aids such as safety bars and surrounding cushion mats).

• - The thin pressure sensor allows for a lightweight, portable mat.

B. Pilot Test.

• - The pilot test will be conducted with a single intervention group who participated in the group exercises using the developed devices that are led by a trainer.

• - Pre- and post-assessment: Two measurements will be taken before and after the intervention, evaluating balance, physical fitness, cognition, and quality of life.

• - User-centered interviews: One interview will be conducted after the intervention to gather participants' opinions on the exercise program and to determine the direction of future studies.

The interview will use the Metaplan method, which was verified as an effective approach for developing assistive systems for older users in a previous study (Thoma-Lürken et al., 2018). The interview will be conducted with four participants from the pilot test, and the interview session will last 60 to 90 minutes, considering participants' needs for breaks. For effective data collection and analysis, the entire interview process will be recorded with participants' prior consent. 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.

• - Random assignment: Block randomization (block size 4) will be applied to randomly assign participants to the intervention group or the control group.

• - Single-blind (blinding of the evaluator): The evaluator will not be informed of the participants' group allocation during assessments.

• - 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.

Arms

Experimental: Intervention group

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.

No Intervention: Control group

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

Interventions

Behavioral: - Fall and dementia prevention exercise

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.