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

Recruiting

• Conditions: pulmonary embolism; venous thromboebolism; 10037454; 10014523

• Registration Number: NL-OMON54292
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 156

Inclusion 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

-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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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