ベータ
治験レーダーAI
治験 NCT07018466 (TEMPO)(対象:Burn Pit Exposure)は募集未定です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
フィルター基準に一致する試験が1件見つかりました
タイル表示

Tele-Exercise for MERP (TEMPO)

募集未定
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07018466 (TEMPO) は 介入研究 臨床試験 で、Burn Pit Exposure に関するものです。現在は 募集未定 で、2026年7月1日 に開始予定です。100 名の参加者 の募集が計画されています。この治験は VA Office of Research and Development によって主催され、2030年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月4日 です。
概要
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.
詳細説明
The most ubiquitous air born hazards resulting from recent conflicts is likely emissions from burn pits used for slow disposal of a variety of wastes, including plastics, petroleum products, metal, rubber, medical waste, and human waste. Burn pits have been used as a waste disposal practice by the United States military for several decades but were more prominent and widespread in the recent conflicts in Iraq and Afghanistan. The burning of these wastes produces toxins that have been demonstrated to produce toxicity in animal and human models and to increase the risk of cardiopulmonary disease in large, population-based studies of Veterans. These include small particulate matter (PM2,5), airborne metal particles, volatile organic compounds (VOCs), and specific byproducts of burnt petroleum products, including polycyclic aromatic hydrocarbons (PAHs).

The long-term health effects of exposure to these toxins are incompletely understood, and the subject of intense research. Increased incidence of cardiopulmonary disease is a major concern in exposed Veterans, with an increased risk of systemic hypertension, COPD, and asthma, all having been recently reported based on a large analysis of Veteran records. Dyspnea is a core symptom linking the pleotropic health effects associated with airborne hazards exposure. A recent study of nearly 2,000 Veterans demonstrated associations between dyspnea and burn pit exposure and exposure to military dusts, gases, and fumes, as well as associations between burn pit exposure and chronic bronchitis.

Among participants in the large-scale Millennium Cohort Study, Veterans who had been deployed reported shortness of breath more frequently than those who were not deployed. As a result, a federally chartered multisite program, the Post-Deployment Cardiopulmonary Evaluation Network (PDCEN), was created specifically to evaluate the causes of underlying exercise intolerance and dyspnea in this group. While this program self-selects for deployed Veterans with symptoms, the magnitude of exercise intolerance in this group is marked.

The investigators hypothesize that Veterans within the VA's Airborne Hazards and Open Burn Pit Registry (AHOBPR) have poor physical function and mobility, and high levels of dyspnea and fatigue. The investigator's global hypothesis is that exercise rehabilitation will improve functional mobility and reduce dyspnea and fatigue in Veterans with military burn pit exposure.

公式タイトル

Tele-Exercise in Veterans With Military Exposure

疾患/病気
Burn Pit Exposure
その他の研究識別子
  • TEMPO
  • CARA-010-24F
NCT番号
開始日
2026-07-01
最終更新日
2025-12-04
終了予定日
2030-12-01
目標参加者数
100
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集未定
キーワード
Exercise
Cardiopulmonary
Military Exposure
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし(非盲検)
群(アーム)/介入
参加グループ/群介入/治療法
実薬対照薬Tele-exercise
Exercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.
遠隔運動
Exercise training 3x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely.
プラセボ対照薬Standard of Care
Health education discussions and lectures 2-3x/week led remotely.
標準治療
Health education discussions and lectures 3x/week led remotely.
主要評価項目
評価指標指標の説明時間枠
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
副次評価項目
評価指標指標の説明時間枠
Change in 2-minute step test
physical function, units are number of times
Baseline and 12-weeks intervention or control
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
40 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  • 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

  • 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
VA Office of Research and Development logoVA Office of Research and Development
試験中央連絡先
連絡先: Alice S Ryan, PhD, (410) 605-7851, [email protected]
1 1カ国の場所

Maryland

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore, Maryland, 21201, United States
Kristina Marcus, MS, 連絡先, 410-605-7000, [email protected]
Alice S. Ryan, PhD, 研究責任者