Fall PreventionSF2NCT05910606
Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program.
A study testing Digital Exercise in people with Fall Prevention and Bone Health, run by University of California, San Diego at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention, Bone Health, Balance
- What is being tested?
- Digital Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Individuals who are wheel-chair bound
- Score 7 or more on the STEADI modified questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
Read the 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
- Being tested
- Digital Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital ExerciseBehavioural
Fall Prevention Program: Our fall- risk reduction program overs digitally delivered exercise with real time feedback from expert instructors.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Digitally delivered strength, balance and postural control exercises Receives: Behavioral: Digital Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
Secondary outcomes (2)
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)
Measured: 12 weeks (post intervention)
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.
Measured: 12 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start1 Sep 2023
- Primary completion16 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Moran, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910606
- Sponsor's protocol ID
- 806696
- Acronym
- SF2
- Status last verified
- Dec 2025
- First submitted
- 24 May 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual data
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05910606
- Acronym / sponsor ID
- SF2 / 806696
- Conditions
- Fall Prevention, Bone Health, Balance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 16 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Digital ExerciseDigitally delivered strength, balance and postural control exercises |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Individuals who are wheel-chair bound
- Score 7 or more on the STEADI modified questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital ExerciseFall Prevention Program: Our fall- risk reduction program overs digitally delivered exercise with real time feedback from expert instructors. | Behavioural | Exercise Intervention |
Primary outcome
Change in the scores from the Short Physical Performance Battery (Balance)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in time to complete the Timed Up and Go (Balance and Function)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in postural sway during the Better Balance Testing (Balance)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in time to complete a 25 foot walk (Balance and function)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in distance covered during a 2.5 minute walk (Aerobic Capacity)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in Grip Strength (Muscular Strength)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in number of chair stands completed in 30 seconds (Muscular Strength)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
Change in a common field measure associated with fall risk. Used to measure leg strength and endurance specifically.
Change in the amount of force generated during isometric assessment of leg strength using BIODEX System 4 PRO (Muscular Strength)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in amount of force generated during isometric assessment of back strength using BIODEX System 4 PRO (Muscular Strength)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in Occipital to Wall Distance (Posture)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in the number of blocks used for the blocks measurement of Kyphosis (Posture)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in height using multiple measures of height (Posture)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
Change in hip Tilt and Shift (Posture)
Time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)
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
2 secondary outcomes
System Usability Scale
Time frame: 12 weeks (post intervention)
User Experience
Time frame: 12 weeks (post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Exercise in people with Fall Prevention and Bone Health, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the scores from the Short Physical Performance Battery (Balance) (time frame: Baseline, 12 weeks (post intervention), 24 weeks (post follow up)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.