Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778604
Status:
RECRUITING
Last Update Posted:
2023-04-26
First Post:
2023-02-16
Brief Title:
Optimizing a Technology-based Body and Mind Intervention
Sponsor:
University of Central Florida
Organization:
University of Central Florida
Study Overview
Official Title:
Optimizing a Technology-based Body and Mind Intervention to Prevent Falls and Reduce Health Disparities in Low-income Populations
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Older adults may feel at risk for falling but do not have a physical risk of falling On the other hand some older adults may not feel at risk for falling but do have a physical risk of falling This study is being done to test a preventative in-home exercise program called PEER which may allow older adults to improve balance align the perceived risk for falling with the physical risk for falling and prevent falls Participants will be asked to participate in this study for approximately 9 months This study has three specific aims
1 Examine differences in balance fall risk and physical activity after program completion follow-up 3 months and 6 months between older adults OAs in the Physio-fEedback Exercise pRogram PEER intervention and OAs in attention control AC condition
2 Explore differences in exercise adherence and the proportion of shifting in fall risk appraisal and negative self-perception on aging after program completion follow-up 3 months and 6 months between OAs in the PEER intervention and OAs in AC condition
3 Explore participants experiences with the PEER intervention and potential barriers to access and adoption of the technology-based PEER intervention to inform future research
Participants will be asked to participate in this study for approximately 9 months This includes the baseline assessment 8 weeks of PEER activities or attention control activities and follow-up assessments at 3 months and 6 months After the informed consent and completion of the baseline assessments participants will be randomized to either the PEER intervention or the attention control AC group Participants in the PEER intervention group will be asked to participate in group exercises 60 minutes per week for 8 weeks and home-based exercises twice a week for 8 weeks that focus on balance strength training with a peer coach Participants in the AC group will receive an information pamphlet developed by the CDC about falls called Simple Exercises for Improving Balance and Preventing Falls in Older Adults Topics include information on fall risks how to prevent falls how to check for safety postural hypotension and chair rise exercises The control group will be encouraged to discuss fall prevention with a primary care provider and continue normal activities
1 Examine differences in balance fall risk and physical activity after program completion follow-up 3 months and 6 months between older adults OAs in the Physio-fEedback Exercise pRogram PEER intervention and OAs in attention control AC condition
2 Explore differences in exercise adherence and the proportion of shifting in fall risk appraisal and negative self-perception on aging after program completion follow-up 3 months and 6 months between OAs in the PEER intervention and OAs in AC condition
3 Explore participants experiences with the PEER intervention and potential barriers to access and adoption of the technology-based PEER intervention to inform future research
Participants will be asked to participate in this study for approximately 9 months This includes the baseline assessment 8 weeks of PEER activities or attention control activities and follow-up assessments at 3 months and 6 months After the informed consent and completion of the baseline assessments participants will be randomized to either the PEER intervention or the attention control AC group Participants in the PEER intervention group will be asked to participate in group exercises 60 minutes per week for 8 weeks and home-based exercises twice a week for 8 weeks that focus on balance strength training with a peer coach Participants in the AC group will receive an information pamphlet developed by the CDC about falls called Simple Exercises for Improving Balance and Preventing Falls in Older Adults Topics include information on fall risks how to prevent falls how to check for safety postural hypotension and chair rise exercises The control group will be encouraged to discuss fall prevention with a primary care provider and continue normal activities
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MD018025 | NIH | None | httpsreporternihgovquickSearchR01MD018025 |