NL-OMON54292招募中不适用
A randomized controlled trial to evaluate the safety and efficacy of an 8-week home-based standardized exercise training program for preventing post-pulmonary embolism syndrome: the PE@HOME study - PE@HOME
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Provision of informed consent prior to any study specific procedures.
- •-Be diagnosed with a confirmed symptomatic acute PE <4 weeks before
- •randomization
- •-Be aged 18 years or older
- •-Report dyspnoea (MRC 2 points or more) and functional limitations (PVFS scale
- •2 or higher)
排除标准
- •-Incapability to follow study procedures (including but not limited to
- •participate in the exercise training program, have WiFi at the patients house
- •to connect the cycle ergometer to the platform, or follow instructions of the
- •research team and complete the web-based PROMS).
- •-Life expectancy shorter than 6 months
- •-Presence of settings (e.g. pregnancy) or comorbidities (e.g. planned surgery
- •or cancer with systemic anticancer therapy) requiring intensive treatment that
- •would interfere with the exercise program
- •- Chronic dyspnoea in the setting of known or suspected serious cardiopulmonary
- •comorbidities: CTEPH, COPD >GOLD II, heart failure > New York Heart Association
- •Classification (NYHA) 2 or interstitial lung diseases.
- •- Previous inclusion in the study
- •- COVID associated pulmonary embolism
- •- CWRT >15 minutes at baseline
- •- Contra-indication for Cardiopulmonary Exercise Testing (CPET) conform
- •ATS-guideline (e.g. severe right ventricular strain with massive PE)
研究者
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