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Clinical Trials/NL-OMON27136
NL-OMON27136
Not Yet Recruiting
N/A

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

MC0 sites90 target enrollmentTBD
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ConditionsPulmonary embolism

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary embolism
Sponsor
MC
Enrollment
90
Status
Not Yet Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
MC

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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