Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT07282951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strong Evidence: Randomized Digitally Delivered Fall-Prevention Exercise Trial in Older Adults
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Strong Evidence: Randomized Digitally Delivered Fall-Prevention Exercise Trial in Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
The investigators have successfully completed a pilot project focused on feasibility and user acceptability of a digitally delivered program for fall prevention in older adults. It was well received among a population of lower and moderate risk individuals. The investigators propose to extend this research by repeating the training program with the inclusion of a wait list control group.
Group A (immediate intervention) will start their initial 12 week exercise program (Intensive Exercise) within 4 weeks of baseline (BL) measurement (as a cohort). This will be followed by an optional additional 12 week exercise program (Maintenance Exercise 2) that participants who complete at least 10 of the Exercise 1 classes will be invited to join. This will be followed by a 12 week wash out period. Measurements will occur each 12 weeks (BL, 12 week post randomization, 24 week post randomization, 36 week post randomization)
Group B (waitlist control) will start with a 12 week life as normal period that is concurrent with Group A's intensive Exercise. They will start Intensive Exercise when Group A is doing Maintenance exercise. They will be invited to Maintenance Exercise while Group A is doing washout. They will not have a washout period. Measurements will occur at the same period(s) as Group A (i.e. all participants measured during the same time period).
The intervention will be identical to what was offered in the past, and measurements will be very similar (removing those that did not show change with intervention or were deemed too difficult for participants).
Group A (immediate intervention) will start their initial 12 week exercise program (Intensive Exercise) within 4 weeks of baseline (BL) measurement (as a cohort). This will be followed by an optional additional 12 week exercise program (Maintenance Exercise 2) that participants who complete at least 10 of the Exercise 1 classes will be invited to join. This will be followed by a 12 week wash out period. Measurements will occur each 12 weeks (BL, 12 week post randomization, 24 week post randomization, 36 week post randomization)
Group B (waitlist control) will start with a 12 week life as normal period that is concurrent with Group A's intensive Exercise. They will start Intensive Exercise when Group A is doing Maintenance exercise. They will be invited to Maintenance Exercise while Group A is doing washout. They will not have a washout period. Measurements will occur at the same period(s) as Group A (i.e. all participants measured during the same time period).
The intervention will be identical to what was offered in the past, and measurements will be very similar (removing those that did not show change with intervention or were deemed too difficult for participants).
Detailed Description:
While fall risk is multifactorial, identification of risk factors and referral to/participation in appropriate fall-risk reduction programs are established as an effective, evidenced-based approach to reduce fall-risk. Specifically, targeted strength and balance exercise have consistently been shown to improve fall risk, and accordingly, the Centers for Disease Control and Prevention (CDC) has outlined an evidenced-based clinical approach to identify those at risk for falls to help assess known risk factors and to refer for community-based fall-prevention programs. This toolkit, however, has been slow to penetrate in routine clinical practice, as barriers reported by physicians to implementing comprehensive falls-prevention screening are time constraints, poor reimbursement for falls screening, and that existing toolkit utilization does not easily fit into a Medicare wellness visit. Because of this, only approximately one-third of older adults report being asked about fall-risk, and similarly only around a third of those who fall report discussing this with their healthcare provider. Compounding this, COVID-19 has created uncertainty in accessing community resources, increased sedentary behavior, isolation and subsequent fall risk. This is especially disconcerting as a single fall predicts recurrent falls with between 10% and 44% of elderly patients with a history of falls sustaining additional falls within five years.
COVID-19 has confounded social isolation in older adults, especially those in congregate settings. Appropriate technology/technologic driven approaches has promise (but limitations) to mitigate some aspects of loneliness/isolation in this population. Digitally delivered programs are an opportunity that help balance risks and benefits during times of social distancing, improve dissemination, and possibly improve objective measures of function. Therefore, approaches to improve access to fall-risk reduction exercise, including balance and strength training opportunities is imperatively important, and growing data suggests digitally formatted delivery may be feasible.
This project also offers the potential to expand our knowledge regarding successful aging using the basic sciences. Specifically, autophagy is the process by which the body packages and recycles damaged proteins and organelles making it essential for maintaining proteostasis and cellular quality control. Autophagy is a dynamic, multi-step process, and static measurements (e.g., protein levels) are insufficient to distinguish increased flux from impaired degradation. Recently, assays of autophagy flux in peripheral blood mononuclear cells (PBMCs) have been developed, enabling minimally invasive, reproducible measurement of this process in human cohorts, but there has currently been limited application to human models. Thus, this project creates a unique opportunity to begin linking autophagy biology with functional outcomes in older adults. Even more meaningfully, autophagy flux in PBMCs has not yet been assessed after any form of exercise, despite the known impact of exercise on functional outcomes and resilience. Establishing PBMC autophagy flux as a biomarker of resilience in this context would address a major translational gap, bridging basic mechanisms of aging biology with functional outcomes of intervention and help guide strategies to maintain health and independence in older adults.
Fall Prevention Program: Our fall- risk reduction program, Strong Foundations, was designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in real time within a small group setting. This is accomplished largely by use of the 'breakout room' feature on the Zoom platform, where 2-3 trained intern instructors correct form while the lead instructor teaches the larger group. The program was designed with physician input and by exercise physiologists and a Doctor of Physical Therapy candidate, all with extensive training in both group and individualized exercise for geriatric populations. Strong Foundations is a 12 week iterative curricular program with three core components: postural alignment and control, balance and mobility, and muscular strength and power. All the exercises offered over the course of the intervention are appropriate for the target population and are standardized so all participants receive the same basic instruction, but level of difficulty is scaled to participant experience, capability, and musculoskeletal limitations.
While many exercise interventions for fall prevention have been validated in different populations, our program is designed with the community in mind and with a novel platform to improve dissemination/availability across many populations.
COVID-19 has confounded social isolation in older adults, especially those in congregate settings. Appropriate technology/technologic driven approaches has promise (but limitations) to mitigate some aspects of loneliness/isolation in this population. Digitally delivered programs are an opportunity that help balance risks and benefits during times of social distancing, improve dissemination, and possibly improve objective measures of function. Therefore, approaches to improve access to fall-risk reduction exercise, including balance and strength training opportunities is imperatively important, and growing data suggests digitally formatted delivery may be feasible.
This project also offers the potential to expand our knowledge regarding successful aging using the basic sciences. Specifically, autophagy is the process by which the body packages and recycles damaged proteins and organelles making it essential for maintaining proteostasis and cellular quality control. Autophagy is a dynamic, multi-step process, and static measurements (e.g., protein levels) are insufficient to distinguish increased flux from impaired degradation. Recently, assays of autophagy flux in peripheral blood mononuclear cells (PBMCs) have been developed, enabling minimally invasive, reproducible measurement of this process in human cohorts, but there has currently been limited application to human models. Thus, this project creates a unique opportunity to begin linking autophagy biology with functional outcomes in older adults. Even more meaningfully, autophagy flux in PBMCs has not yet been assessed after any form of exercise, despite the known impact of exercise on functional outcomes and resilience. Establishing PBMC autophagy flux as a biomarker of resilience in this context would address a major translational gap, bridging basic mechanisms of aging biology with functional outcomes of intervention and help guide strategies to maintain health and independence in older adults.
Fall Prevention Program: Our fall- risk reduction program, Strong Foundations, was designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in real time within a small group setting. This is accomplished largely by use of the 'breakout room' feature on the Zoom platform, where 2-3 trained intern instructors correct form while the lead instructor teaches the larger group. The program was designed with physician input and by exercise physiologists and a Doctor of Physical Therapy candidate, all with extensive training in both group and individualized exercise for geriatric populations. Strong Foundations is a 12 week iterative curricular program with three core components: postural alignment and control, balance and mobility, and muscular strength and power. All the exercises offered over the course of the intervention are appropriate for the target population and are standardized so all participants receive the same basic instruction, but level of difficulty is scaled to participant experience, capability, and musculoskeletal limitations.
While many exercise interventions for fall prevention have been validated in different populations, our program is designed with the community in mind and with a novel platform to improve dissemination/availability across many populations.
Study Oversight
Has Oversight DMC:
False
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?: