Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program.

NCT ID: NCT05910606

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-08-31

Brief Summary

Study Description: The investigators propose to extend earlier research conducted during a feasibility study (Strong Foundations 1.0) by enrolling participants who have a greater risk for falling (x4 cohorts of up to 15 individuals) and from a lower socio-economic status (x4 cohorts of up to 15 individuals), and by collecting high quality laboratory based measures of balance, posture, and strength to better determine the effectiveness of the program and its suitability for widespread deployment.

Additionally, the investigators hope to showcase it is feasible to sustain programmatic gains with ongoing digitally delivered content by combining cohorts into a larger group that continues to practice the foundational exercises taught during the 12-week initial program.

Detailed Description

Study Description: 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. This program was well received among participants of lower risk individuals, and with this extension we will be exploring the acceptability, utility, and scalability in both a higher risk and lower socio-economic status group of older adults.

The primary goal of this program is to reduce fall risk using a digitally delivered exercise intervention with a high level of personalized instruction for the initial portion of the intervention (12 weeks) and to maintain any established reduction in fall risk in an ongoing, pooled cohort extended beyond the initial 12 weeks of training that features a smaller amount of personalized instruction .

The investigators will extend earlier research using a digitally delivered fall-prevention exercise program by engaging 1) two cohorts of up to 15 individuals each at low to average risk of falls and 2) two additional cohorts, of up to 15 individuals with established risk factors for falling identified from the larger San Diego community and a similar number of cohorts/individuals in collaboration with community partners who provide housing for a population from lower socio-economic status, and potentially less access to, and comfort with digital technology. Thus, in total the investigators will enroll up to 120 participants across all sites/settings through this timeframe.

Description of Study Intervention:

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.

This 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.

Conditions

Fall Prevention; Bone Health; Balance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise Intervention

Digitally delivered strength, balance and postural control exercises

Group Type: EXPERIMENTAL

Digital Exercise

Intervention Type: BEHAVIORAL

Fall Prevention Program: Our fall- risk reduction program overs digitally delivered exercise with real time feedback from expert instructors.

Interventions

Digital Exercise

Fall Prevention Program: Our fall- risk reduction program overs digitally delivered exercise with real time feedback from expert instructors.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 60 or older, ambulatory, including with the use of a cane or walker, and able to read and speak English.
• Completion of the STEADI Stay Independent Questionnaire (with score of 6 or less)
• Access to internet/computer and Zoom-interface / broadband with a device with a minimum screen size of 7 inches (i.e. tablet or larger).

Exclusion Criteria

• Individuals who are wheel-chair bound
• Score 7 or more on the STEADI modified questionnaire

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Ryan Moran

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCSD Health

San Diego, California, United States

Countries

United States

Other Identifiers

806696

Identifier Type: -

Identifier Source: org_study_id