Strong Evidence: Digitally Delivered Exercise in Older Adults

NCT ID: NCT07282951

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-15
• Study Completion Date: 2027-01-01

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).

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.

Conditions

Fall Prevention; Fall Prevention in Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Immediate Intervention: Group A

• Group A: who will start their 12-week exercise program with the Intensive Intervention within 4 weeks of baseline measurement. For those who qualify (see below) this will be followed by a 12-week maintenance program. This group will finish the program with 12 weeks life as usual.

Group Type: EXPERIMENTAL

Digitally Delivered Exercise

Intervention Type: BEHAVIORAL

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.

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 capability.

Delayed Intervention: Group B

• Broup B: who willl have a 12 week lead in period of life as usual. They will then begin their 12-week intensive intervention. Those who qualify, this will be followed by a 12-week maintenance program.

Group Type: EXPERIMENTAL

Digitally Delivered Exercise

Intervention Type: BEHAVIORAL

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.

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 capability.

Interventions

Digitally Delivered Exercise

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.

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 capability.

Intervention Type: BEHAVIORAL

Other Intervention Names

Strong Foundations

Eligibility Criteria

Inclusion Criteria

• Has the capacity to provide informed consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Age 60 or older, ambulatory, including with the use of a cane or walker, and able to read and speak English.
• Access to internet/computer and Zoom-interface / broadband with a device with a minimum screen size of 7 inches (i.e. tablet or larger).
• Completion of the Stopping Elderly Accidents, Deaths & Injuries (STEADI) Stay Independent Risk for Falling Questionnaire (uploaded as Supporting materials). NOTE: A score of 7 or greater will make a participant ineligible for this study (see below).

Exclusion Criteria

• Individuals who are wheel-chair bound
• Score 7 or more on the STEADI Risk for Falling questionnaire.
• Individuals who have non removable (i.e. implanted) electrically driven medical implants (pacemakers, cochlear implants, etc)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanford Burnham Prebys

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Ryan Moran

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Kumstra, PhD

Role: PRINCIPAL_INVESTIGATOR

Sanford Burnham Prebys

Ryan Moran, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

San Diego, California, United States

Countries

United States

Central Contacts

David Wing, PhD

Role: CONTACT

dwing@health.ucsd.edu

18585349315

Ryan Moran, MD, MPH

Role: CONTACT

rjmoran@health.ucsd.edu

References

Bansal S, Katzman WB, Giangregorio LM. Exercise for improving age-related hyperkyphotic posture: a systematic review. Arch Phys Med Rehabil. 2014 Jan;95(1):129-40. doi: 10.1016/j.apmr.2013.06.022. Epub 2013 Jul 9.

Reference Type: BACKGROUND

PMID: 23850611 (View on PubMed)

Wing D, Nichols JF, Barkai HS, Culbert O, Moreno D, Higgins M, O'Brien A, Perez M, Davey H, Moran R. Building Strong Foundations: Nonrandomized Interventional Study of a Novel, Digitally Delivered Fall Prevention Program for Older Adults. JMIR Aging. 2025 Feb 26;8:e68957. doi: 10.2196/68957.

Reference Type: BACKGROUND

PMID: 40009847 (View on PubMed)

Jacobson CL, Foster LC, Arul H, Rees A, Stafford RS. A Digital Health Fall Prevention Program for Older Adults: Feasibility Study. JMIR Form Res. 2021 Dec 23;5(12):e30558. doi: 10.2196/30558.

Reference Type: BACKGROUND

PMID: 34837492 (View on PubMed)

Gill TM. Assessment of function and disability in longitudinal studies. J Am Geriatr Soc. 2010 Oct;58 Suppl 2(Suppl 2):S308-12. doi: 10.1111/j.1532-5415.2010.02914.x.

Reference Type: BACKGROUND

PMID: 21029059 (View on PubMed)

Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988 Dec 29;319(26):1701-7. doi: 10.1056/NEJM198812293192604.

Reference Type: BACKGROUND

PMID: 3205267 (View on PubMed)

Sarmiento K, Lee R. STEADI: CDC's approach to make older adult fall prevention part of every primary care practice. J Safety Res. 2017 Dec;63:105-109. doi: 10.1016/j.jsr.2017.08.003. Epub 2017 Sep 4.

Reference Type: BACKGROUND

PMID: 29203005 (View on PubMed)

Stevens JA, Phelan EA. Development of STEADI: a fall prevention resource for health care providers. Health Promot Pract. 2013 Sep;14(5):706-14. doi: 10.1177/1524839912463576. Epub 2012 Nov 16.

Reference Type: BACKGROUND

PMID: 23159993 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

812960

Identifier Type: -

Identifier Source: org_study_id