Strong Evidence: Digitally Delivered Exercise in Older Adults

NCT07282951 | Active Not Recruiting

• 2 other identifiers: 812960UM1TR005449
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Fall Prevention; Fall Prevention in Healthy Aging

Keywords

Fall Prevention; Digital Exercise; Digital; Group Exercise; Exercise; Older Adults; Fracture prevention; Balance; Strength; Posture

Outcome Measures

Primary Outcomes (1)

• 30 second chair stand

  The 30-Second Chair Stand is intended to evaluate lower body and hip flexor strength and short endurance. This assessment is easy and quick to administer, and has been shown to predict falls with cut-offs that are age and gender adjusted. Individuals are instructed to sit in in an arm-less chair of approximately 17 inch seat-height, cross their arms across the chest, keep their feet flat on the floor and back straight, and sequentially rise and sit as many times as possible within a 30-second time frame

  Baseline, 12 weeks, 24 weeks, 36 weeks

Secondary Outcomes (6)

• Grip Strength

  Baseline, 12 weeks, 24 weeks, 36 weeks

• Occipital to Wall Distance

  BL, 12 weeks, 24 weeks, 36 weeks

• Short Physical Performance Battery (SPPB)

  Baseline, 12 weeks, 24 weeks, 36 weeks

• The Timed Up and Go (TUG)

  Baseline, 12 weeks, 24 weeks, 36 weeks

• Body Muscle

  Baseline, 12 weeks, 24 weeks, 36 weeks

Study Arms (2)

Immediate Intervention: Group A

EXPERIMENTAL

• 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.

Behavioral: Digitally Delivered Exercise

Delayed Intervention: Group B

EXPERIMENTAL

• 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.

Behavioral: Digitally Delivered Exercise

Interventions

Digitally Delivered Exercise 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.

Also known as: Strong Foundations

Delayed Intervention: Group B; Immediate Intervention: Group A

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• University of California, San Diego: lead
• Sanford Burnham Prebys: collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

Related Publications (7)

• 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.

  PMID: 23850611 BACKGROUND

• 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.

  PMID: 40009847 BACKGROUND

• 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.

  PMID: 34837492 BACKGROUND

• 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.

  PMID: 21029059 BACKGROUND

• 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.

  PMID: 3205267 BACKGROUND

• 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.

  PMID: 29203005 BACKGROUND

• 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.

  PMID: 23159993 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Caroline Kumstra, PhD

  Sanford Burnham Prebys

  PRINCIPAL INVESTIGATOR

• Ryan Moran, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: As such individuals will be randomized by cohort into either * 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. * 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.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-01

Locations

US (1)