Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program.

NCT05910606 | Active Not Recruiting

• 1 other identifier: 806696
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Prevention; Bone Health; Balance

Outcome Measures

Primary Outcomes (13)

• Change in the scores from the Short Physical Performance Battery (Balance)

  Change in composite score and individual scores for all components Summary Score 0-12 with higher values being indicative of better performance. Positive change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention. Gait Speed: Measured in m/sec with higher values being indicative of better performance and lower risk Positive change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention 5 repetition chair stands: Scored in seconds with lower values being indicative of better performance and lower risk. Negative change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention Balance: 0-10 seconds with higher time indicative of better balance and lower risk. Positive change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in time to complete the Timed Up and Go (Balance and Function)

  Change in the time to complete a standardized assessment of functional mobility and fall risk that times a participant's ability to get up out of chair, walk 8 feet, navigate an obstacle and return to a seated position Measured in seconds with variable possible length. Faster times are indicative of better performance and lower risk. Negative change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in postural sway during the Better Balance Testing (Balance)

  Changes in the amount of movement (postural sway) observed during a standardized measure of balance on a force platform. This is a well validated measure of proprioceptive and vestibular function utilizing computerized dynamic posturography (i.e. balance board that measures center of pressure and postural sway) Measured in mm of sway with range 0 - ?. Lower scores are indicative of greater stability and lower risk. Negative change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in time to complete a 25 foot walk (Balance and function)

  Change in time to complete a standardized assessment of gait speed and variability commonly used to assess fall risk. Measured in seconds to calculate gait speed in m/sec. Lower times (in sec) and higher speeds (in m/sec) are indicative of better function and lower risk. Negative change scores (T2-BL or T1-BL or T2-T1) for time will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in distance covered during a 2.5 minute walk (Aerobic Capacity)

  Change in the distance (and estimated aerobic capacity derived from distance) on a standardized walk test to measure aerobic endurance and estimate overall capacity Measured in meters with variable range. Higher scores are indicative of greater cardiovascular function and lower risk. Positive change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in Grip Strength (Muscular Strength)

  Change in a Standardized assessment to assess muscular strength. Used because it correlates well with overall body strength. Measured in kg for both hands and averaged with a variable range. Higher scores are indicative of greater muscular strength and lower risk. Positive change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in number of chair stands completed in 30 seconds (Muscular Strength)

  Change in a common field measure associated with fall risk. Used to measure leg strength and endurance specifically.

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in the amount of force generated during isometric assessment of leg strength using BIODEX System 4 PRO (Muscular Strength)

  Change in the amount of force generated during maximal exertion for short time against an immovable object at 3 joint angles to measure hamstring and quadricep strength

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in amount of force generated during isometric assessment of back strength using BIODEX System 4 PRO (Muscular Strength)

  Chage in the amount of force generated during maximal exertion for short time against an immovable object at 3 joint angles to measure strength of the muscles surrounding the lumbar and thoracic spine. Positive change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in Occipital to Wall Distance (Posture)

  Change in common measurement of the curvature of the thoracic and cervical spine done in standing position Score range is in mm and is variable. Higher values indicate more kyphotic curve and are associated with worse outcomes. Negative change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in the number of blocks used for the blocks measurement of Kyphosis (Posture)

  Measurement of the curvature of the thoracic and cervical spine done in a supine position Range 0-7 with higher values indicative of more kyphosis and worse outcomes. Negative change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in height using multiple measures of height (Posture)

  Changes in the difference between height measured while standing "normally" vs. "as tall as possible" to measure height loss due to spinal curvature in the absence of muscular engagement. Measurement in mm of difference with higher scores indicative of greater non specific postural imbalance/deformity and are associated with worse outcomes. Negative change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

• Change in hip Tilt and Shift (Posture)

  Changes in standardized physical therapy based assessments of left/right and forward/backward symmetry of hips, shoulders and ankles Measured in degrees with a likely range of 0-15. Greater values are indicative of non specific postural imbalance/deformity and are associated with worse outcomes. Negative change scores (T2-BL or T1-BL or T2-T1) will be associated with improved performance following intervention

  Baseline, 12 weeks (post intervention), 24 weeks (post follow up)

Secondary Outcomes (2)

• System Usability Scale

  12 weeks (post intervention)

• User Experience

  12 weeks (post intervention)

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Digitally delivered strength, balance and postural control exercises

Behavioral: Digital Exercise

Interventions

Digital Exercise BEHAVIORAL

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

Exercise Intervention

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Health

San Diego, California, 92122, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 20, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)