FallsENHANCENCT07206368
Health Promotion With Targeted Exercise Intervention for Decreasing Fall Risk and Inactivity in Aging Veterans With Obesity and Signs of Sarcopenia
A study testing Fall prevention exercise and Health promotion education in people with Falls and Sarcopenia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Falls are a major health risk for older Veterans, especially those with both obesity and low muscle mass or strength (sarcopenia), which together increase the chances of falling and losing independence. Many older Veterans have difficulty staying active and often lack information about how to safely exercise. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Falls, Sarcopenia, Obesity
- What is being tested?
- Fall prevention exercise and Health promotion education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 May 2031
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran status
- 55 years or older
- VA primary care provider
- Enrolled in the VA Maryland Health Care System for health care
- Body mass index between and including 30 - 40 kg/m^2
- Showing signs of sarcopenia
Who cannot join
- Poorly controlled hypertensin
- Home oxygen use
- Contraindications to exercise or resistance exercise
- Significant cognitive impairment
- Other medical condition precluding patient participation in this study per the medical judgement of the study team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Julie S Rekant, DPT PhD, (410) 605-7000, Julie.Rekant@va.gov
Olivia Porcello, BS, (410) 605-7000, porcello.olivia@va.gov
About this study
Falls are a major health risk for older Veterans, especially those with both obesity and low muscle mass or strength (sarcopenia), which together increase the chances of falling and losing independence. Many older Veterans have difficulty staying active and often lack information about how to safely exercise. While current guidelines focus mostly on weight loss, losing weight alone can weaken muscles and bones, which may actually raise the risk of falls and injuries. This study is testing the benefits of a virtual group exercise program combined with health education. The goal is to find out if exercise combined with health education is better at lowering fall risk and improving daily activity than health education alone for Veterans with obesity and signs of sarcopenia.
Read the detailed description
Veterans with age-related declines in muscle mass and function, known as sarcopenia, are more likely to experience a fall, functional decline, and have higher mortality risk. Experiencing falls and limited functional mobility related to sarcopenia contributes to poor overall health, limited community participation, and loneliness, especially for Veterans with obesity. This group is uniquely vulnerable, as traditional weight-loss focused interventions may worsen muscle and bone loss, paradoxically increasing fall and injury risk. There is an urgent need to identify a feasible and efficacious intervention to address functional limitation and fall risk in aging Veterans with obesity and sarcopenia which does not further compromise their health.
This project departs from the traditional weight-loss approach for older Veterans with obesity by prioritizing functional health and fall risk reduction through targeted exercise and health education, specifically for those with sarcopenia. The intervention leverages a live, virtual group format to overcome mobility and access barriers, integrates wearable sensors for precise outcome measurement, and addresses both physical and behavioral aspects of fall prevention in a scalable, Veteran-centered design. The project addresses key knowledge gaps including: the lack of tailored fall prevention strategies for older Veterans with both obesity and sarcopenia; limited evidence on whether exercise interventions are superior to health education alone in this population; and uncertainties about the best ways to preserve muscle quality and reduce disability without compromising functional health through traditional weight-loss approaches. It also explores how virtual, group-based delivery can overcome access barriers for at-risk Veterans. The investigators will address these knowledge gaps through the following aims:
Aim 1: Compare the effects of a targeted exercise-based fall prevention intervention plus health promotion education program vs. health promotion education alone on clinical measures of fall risk and dysmobility. The investigators hypothesize Veterans participating in the combined exercise and health education program will show greater reductions in fall risk (primary outcome: Four Square Step Test (FSST)) compared to those receiving education alone.
Aim 2: Determine if combined exercise and health education and/or health promotion education alone result in physical activity changes indicative of greater ability to engage/engagement in community mobility. The investigators hypothesize Veterans participating in combined exercise and health education and those receiving health promotion education alone will show increased community mobility abilities evidenced by improved physical activity engagement (primary outcome: weekly minutes of moderate-vigorous physical activity), as measured through accelerometry. Those in combined exercise and health education are expected to have greater improvements compared to those in health promotion education alone.
Aim 3: Determine if combined exercise and health education and/or health promotion education alone result in changes to lower extremity muscle quality. The investigators hypothesize Veterans participating in combined exercise and health education will demonstrate improvements in functional muscle quality (primary outcome: knee extension strength) which are not expected to be observed for those in health promotion education alone.
This study will inform tailored strategies for fall prevention in aging Veterans with obesity and sarcopenia, supporting updated clinical practice guidelines that go beyond weight loss. It leverages innovative, scalable, Veteran-centered virtual interventions designed to optimize independence for Veterans at high risk for falls.
- Conditions
- Falls, Sarcopenia, Obesity
- Being tested
- Fall prevention exercise, Health promotion education
- Keywords
- fall
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall prevention exerciseOther
Also called EX
Participants will attend a virtual exercise-based group fall prevention class that focuses on movement and obstacle negotiation 3 times per week for 3 months.
Health promotion educationOther
Also called EDU
Participants will attend a virtual group health promotion education class that focuses on reasons to maintain a healthy lifestyle and local resources to support them in this. The sessions will take place 1 time per week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| EX + EDU | Experimental | Participation in a live virtual fall-prevention exercise intervention plus a health promotion education program. Receives: Other: Fall prevention exercise; Other: Health promotion education |
| EDU | Active comparator | Participation in a live virtual health promotion education program alone. Receives: Other: Health promotion education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
The four-square step test will be used as a measure of balance. The change in amount of time it takes to complete the four-square step test is compared pre and post intervention
Measured: 3 months
Physical activity
Weekly minutes of moderate-vigorous physical activity will be used as a measure of physical activity. The change in amount of weekly minutes is compared pre to post intervention.
Measured: 3 months
Knee extension strength
A measure of the maximal isometric muscle strength produced in knee extensor muscles will be assessed with a handheld dynamometer device. Pre and post intervention levels will be compared.
Measured: 3 months
Secondary outcomes (1)
Mobility
The timed up and go will be used as a measure of mobility. The change in amount of time it takes to complete the timed up and go test is compared pre to post intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Apr 2026
- Primary completion1 May 2030 (estimated)
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie S Rekant, DPT PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206368
- Sponsor's protocol ID
- RRD8-002-24W
- Other IDs
- 1IK2RD000462
- Acronym
- ENHANCE
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion With Targeted Exercise Intervention for Decreasing Fall Risk and Inactivity in Aging Veterans With Obesity and Signs of Sarcopenia
- ClinicalTrials.gov ID
- NCT07206368
- Acronym / sponsor ID
- ENHANCE / RRD8-002-24W
- Conditions
- Falls, Sarcopenia, Obesity
- Keywords
- fall
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 30 May 2031 (estimated)
- First posted
- 3 Oct 2025 (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.
Falls are a major health risk for older Veterans, especially those with both obesity and low muscle mass or strength (sarcopenia), which together increase the chances of falling and losing independence. Many older Veterans have difficulty staying active and often lack information about how to safely exercise. While current guidelines focus mostly on weight loss, losing weight alone can weaken muscles and bones, which may actually raise the risk of falls and injuries. This study is testing the benefits of a virtual group exercise program combined with health education. The goal is to find out if exercise combined with health education is better at lowering fall risk and improving daily activity than health education alone for Veterans with obesity and signs of sarcopenia.
Detailed description
Veterans with age-related declines in muscle mass and function, known as sarcopenia, are more likely to experience a fall, functional decline, and have higher mortality risk. Experiencing falls and limited functional mobility related to sarcopenia contributes to poor overall health, limited community participation, and loneliness, especially for Veterans with obesity. This group is uniquely vulnerable, as traditional weight-loss focused interventions may worsen muscle and bone loss, paradoxically increasing fall and injury risk. There is an urgent need to identify a feasible and efficacious intervention to address functional limitation and fall risk in aging Veterans with obesity and sarcopenia which does not further compromise their health.
This project departs from the traditional weight-loss approach for older Veterans with obesity by prioritizing functional health and fall risk reduction through targeted exercise and health education, specifically for those with sarcopenia. The intervention leverages a live, virtual group format to overcome mobility and access barriers, integrates wearable sensors for precise outcome measurement, and addresses both physical and behavioral aspects of fall prevention in a scalable, Veteran-centered design. The project addresses key knowledge gaps including: the lack of tailored fall prevention strategies for older Veterans with both obesity and sarcopenia; limited evidence on whether exercise interventions are superior to health education alone in this population; and uncertainties about the best ways to preserve muscle quality and reduce disability without compromising functional health through traditional weight-loss approaches. It also explores how virtual, group-based delivery can overcome access barriers for at-risk Veterans. The investigators will address these knowledge gaps through the following aims:
Aim 1: Compare the effects of a targeted exercise-based fall prevention intervention plus health promotion education program vs. health promotion education alone on clinical measures of fall risk and dysmobility. The investigators hypothesize Veterans participating in the combined exercise and health education program will show greater reductions in fall risk (primary outcome: Four Square Step Test (FSST)) compared to those receiving education alone.
Aim 2: Determine if combined exercise and health education and/or health promotion education alone result in physical activity changes indicative of greater ability to engage/engagement in community mobility. The investigators hypothesize Veterans participating in combined exercise and health education and those receiving health promotion education alone will show increased community mobility abilities evidenced by improved physical activity engagement (primary outcome: weekly minutes of moderate-vigorous physical activity), as measured through accelerometry. Those in combined exercise and health education are expected to have greater improvements compared to those in health promotion education alone.
Aim 3: Determine if combined exercise and health education and/or health promotion education alone result in changes to lower extremity muscle quality. The investigators hypothesize Veterans participating in combined exercise and health education will demonstrate improvements in functional muscle quality (primary outcome: knee extension strength) which are not expected to be observed for those in health promotion education alone.
This study will inform tailored strategies for fall prevention in aging Veterans with obesity and sarcopenia, supporting updated clinical practice guidelines that go beyond weight loss. It leverages innovative, scalable, Veteran-centered virtual interventions designed to optimize independence for Veterans at high risk for falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EX + EDU | Experimental | Other: Fall prevention exercise, Other: Health promotion educationParticipation in a live virtual fall-prevention exercise intervention plus a health promotion education program. |
| EDU | Active comparator | Other: Health promotion educationParticipation in a live virtual health promotion education program alone. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veteran status
- 55 years or older
- VA primary care provider
- Enrolled in the VA Maryland Health Care System for health care
- Body mass index between and including 30 - 40 kg/m^2
Key exclusion criteria (5 listed)
- Poorly controlled hypertensin
- Home oxygen use
- Contraindications to exercise or resistance exercise
- Significant cognitive impairment
- Other medical condition precluding patient participation in this study per the medical judgement of the study team
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 |
|---|---|---|
| Fall prevention exerciseAlso: EXParticipants will attend a virtual exercise-based group fall prevention class that focuses on movement and obstacle negotiation 3 times per week for 3 months. | Other | EX + EDU |
| Health promotion educationAlso: EDUParticipants will attend a virtual group health promotion education class that focuses on reasons to maintain a healthy lifestyle and local resources to support them in this. The sessions will take place 1 time per week for 3 months. | Other | EDU, EX + EDU |
Primary outcome
Balance
Time frame: 3 months
The four-square step test will be used as a measure of balance. The change in amount of time it takes to complete the four-square step test is compared pre and post intervention
Physical activity
Time frame: 3 months
Weekly minutes of moderate-vigorous physical activity will be used as a measure of physical activity. The change in amount of weekly minutes is compared pre to post intervention.
Knee extension strength
Time frame: 3 months
A measure of the maximal isometric muscle strength produced in knee extensor muscles will be assessed with a handheld dynamometer device. Pre and post intervention levels will be compared.
1 secondary outcome
Mobility
Time frame: 3 months
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 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Julie S Rekant, DPT PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall prevention exercise and Health promotion education in people with Falls and Sarcopenia, run by VA Office of Research and Development 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. 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?
Contact Julie S Rekant, DPT PhD ((410) 605-7000, Julie.Rekant@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 3 months). The study lists 3 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 21 Apr 2026.