Clinical trial NCT05910606: Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program.
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fall Prevention
Bone Health
Balance
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-06-20
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in the scores from the Short Physical Performance Battery (Balance)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in time to complete the Timed Up and Go (Balance and Function)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in postural sway during the Better Balance Testing (Balance)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in time to complete a 25 foot walk (Balance and function)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in distance covered during a 2.5 minute walk (Aerobic Capacity)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in Grip Strength (Muscular Strength)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in number of chair stands completed in 30 seconds (Muscular Strength)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in the amount of force generated during isometric assessment of leg strength using BIODEX System 4 PRO (Muscular Strength)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in amount of force generated during isometric assessment of back strength using BIODEX System 4 PRO (Muscular Strength)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in Occipital to Wall Distance (Posture)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in the number of blocks used for the blocks measurement of Kyphosis (Posture)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in height using multiple measures of height (Posture)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
measure: Change in hip Tilt and Shift (Posture)
timeFrame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
Secondary outcomes:
measure: System Usability Scale
timeFrame: 12 weeks (post intervention)
measure: User Experience
timeFrame: 12 weeks (post intervention)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Health
state: California
Study officials:
References: