A randomized trial to evaluate a home-based standardized exercise training program for preventing post-pulmonary embolism syndrome

• Conditions: Pulmonary embolism

• Registration Number: NL-OMON27136
• Lead Sponsor: MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the relative increase in CWRT (%). Calculated as: (CWRT after intervention [seconds] – CWRT at baseline [seconds]) / CWRT at baseline [seconds].