Health Promotion With Targeted Exercise Intervention for Decreasing Fall Risk and Inactivity in Aging Veterans With Obesity and Signs of Sarcopenia

NCT07206368 | Recruiting DMC

• 2 other identifiers: RRD8-002-24W1IK2RD000462
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Falls; Sarcopenia; Obesity

Keywords

fall

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  3 months

Secondary Outcomes (1)

• Mobility

  3 months

Study Arms (2)

EX + EDU

EXPERIMENTAL

Participation in a live virtual fall-prevention exercise intervention plus a health promotion education program.

Other: Fall prevention exercise; Other: Health promotion education

EDU

ACTIVE COMPARATOR

Participation in a live virtual health promotion education program alone.

Other: Health promotion education

Interventions

Fall prevention exercise OTHER

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.

Also known as: EX

EX + EDU

Health promotion education OTHER

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.

Also known as: EDU

EDU; EX + EDU

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran status
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Obesity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Julie S Rekant, DPT PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie S Rekant, DPT PhD

CONTACT

(410) 605-7000; Julie.Rekant@va.gov

Olivia Porcello, BS

CONTACT

(410) 605-7000; porcello.olivia@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 30, 2031
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)