Tele-Exercise for MERP

NCT07018466 | Not Yet Recruiting DMC

• 1 other identifier: CARA-010-24F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

During Operations Desert Shield and Desert Storm, Veterans in combat were exposed to a variety of airborne hazards, including oil well fire smoke, emissions from burn pits, and other substances associated with negative health outcomes, including cardiovascular and pulmonary disease and cancer. More than 40% of Veterans enrolled in the VA's Airborne Hazards and Open Burn Pit Registry (AHOBPR) report functional limitations, such as difficulty running short distances. Veterans with burn pit exposures will benefit from physical activity interventions designed to improve functional ability and overall quality of life. Veterans with significant exposure to burn pits during their overseas military service will have a detailed documentation of their limitations and participate in either a 12-week coach-led tele-exercise intervention or standard of care. This project is designed to improve functional mobility and could be implemented for Veterans with burn pit exposure.

Conditions

Burn Pit Exposure

Keywords

Exercise; Cardiopulmonary; Military Exposure

Outcome Measures

Primary Outcomes (2)

• Change in VO2peak

  physical fitness, units are ml/kg/min

  Baseline and 12 weeks intervention or control

• Change in 6-minute walk test

  distance, units are m

  Baseline and 12-weeks intervention or control

Secondary Outcomes (1)

• Change in 2-minute step test

  Baseline and 12-weeks intervention or control

Study Arms (2)

Tele-exercise

ACTIVE COMPARATOR

Exercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.

Other: Tele-exercise

Standard of Care

PLACEBO COMPARATOR

Health education discussions and lectures 2-3x/week led remotely.

Other: Standard of Care

Interventions

Tele-exercise OTHER

Exercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.

Tele-exercise

Standard of Care OTHER

Health education discussions and lectures 3x/week led remotely.

Standard of Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• Age \> or equal to 40 years
• Self-reported exposure to burn pits and/or burn pit smoke during overseas military deployment (at least 6 hours per day during one or more deployments of at least three months)
• ability to interact with study staff using video conferencing technology
• ability to provide written informed consent

You may not qualify if:

• Musculoskeletal or medical conditions which preclude participation in a tele-exercise program
• Active severe mental health or psychiatric issues, including suicidality
• Severe pulmonary disease (chronic supplemental oxygen), or lobectomy or greater resection
• Myocardial infarction (within 3 months), or exertional or unstable angina
• Uncontrolled systemic hypertension, defined as resting systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 at time of most recent evaluation at time of recruitment
• Active systemic treatment for cancer
• Acute care hospitalization within the last 90 days
• End-stage liver or renal disease
• Any other medical or psychiatric condition that would preclude safe participation in tele-exercise, according to the judgment of the investigators

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

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alice S. Ryan, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice S Ryan, PhD

CONTACT

(410) 605-7851; Alice.Ryan@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Tele-exercise or standard of care control

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)