Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program.

Balance Clinical Trial

— SF2  

Official title:

Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program for Remote Deployment of Exercise in an At-risk Population of Older Adults.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05910606
• Other study ID #: 806696
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Balance
• Bone Health
• Fall Prevention

Intervention

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

Locations

Country	Name	City	State
United States	UCSD Health	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	System Usability Scale	Validated Scale to assess program's accessibility and perceived usefulness. Score range 20-100 with higher scores being indicative of more perceived usability (i.e. greater acceptability)	12 weeks (post intervention)
Secondary	User Experience	Non-standardized Likert scale questions asking about participant's experience with the digital format including feelings of safety, engagement, and program enjoyment. Range 1-5. Some are positively coded so that higher scores are indicative of better acceptability and some are negatively coded so that lower scores are indicative of better acceptability.	12 weeks (post intervention)