治験レーダーAI | ||
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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。 | ||
Tele-Exercise for MERP (TEMPO)
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.
Tele-Exercise in Veterans With Military Exposure
- TEMPO
- CARA-010-24F
Cardiopulmonary
Military Exposure
| 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. |
| 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 |
| 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 |
- 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
Maryland