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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Julie S Rekant, DPT PhD contact

(410) 605-7000

Julie.Rekant@va.gov

Olivia Porcello, BS contact

(410) 605-7000

porcello.olivia@va.gov

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

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 groups in NCT07206368
Study groupRoleWhat they receive
EX + EDUExperimentalParticipation in a live virtual fall-prevention exercise intervention plus a health promotion education program.
Receives: Other: Fall prevention exercise; Other: Health promotion education
EDUActive comparatorParticipation 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.

  1. 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

  2. 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

  3. 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)
  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.

  1. First posted3 Oct 2025
  2. Study start1 Apr 2026
  3. Primary completion1 May 2030 (estimated)
  4. Study completion30 May 2031 (estimated)

Resources

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)
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

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.

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