NL-OMON27136尚未招募不适用
A randomized trial to evaluate a home-based standardized exercise training program for preventing post-pulmonary embolism syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- MC
- 入组人数
- 90
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
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •?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
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •?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 training program
- •?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
- •?If a patient has contra-indication for CPET as determined by the treating physician considering the ATS-guideline
研究者
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