Status:
UNKNOWN
Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism
Lead Sponsor:
Ostfold Hospital Trust
Collaborating Sponsors:
University Hospital, Akershus
Ullevaal University Hospital
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This project aims to evaluate a rehabilitation program as treatment and uncover potential pathophysiological mechanisms of a newly identified chronic condition named "Post Pulmonary Embolism Syndrome"...
Detailed Description
The newly identified Post Pulmonary Embolism Syndrome (PPS) is characterized by chronic persistent, but unexplained dyspnea (i.e. without signs of pulmonary hypertension or pulmonary abnormality). Sym...
Eligibility Criteria
Inclusion
- Objectively diagnosed symptomatic pulmonary embolism by CTPA or high-probability scintigraphy 6 months to 6 years before inclusion
- Persistent dyspnea defined as modified Medical Research Council (mMRC) breathlessness scale \>= 1 that has appeared or worsened after the diagnosis of PE (eligibility criteria for randomization)
Exclusion
- Significant pulmonary disease (COPD GOLD \>= 2, restrictive pulmonary disease, lung cancer or pleural disease.
- Heart failure (either HFrEF, HFmrEF or HFpEF as defined in ESC guidelines)
- Significant valvular heart disease
- Chronic thromboemboli pulmonary hypertension (CTEPH)
- Patients unfit for rehabilitation or walking tests du to old age, physical disability or disease
- Patients with a history of poor compliance or any condition that would interfere with the ability to comply with the study protocol e.g. history of drug abuse, excessive alcohol beverage consumption, cognitive dysfunction or severe psychiatric disease
- Active malignancy
- Life expectancy less than 3 months
- Pregnancy
Key Trial Info
Start Date :
January 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT03405480
Start Date
January 20 2018
End Date
March 30 2024
Last Update
November 3 2023
Active Locations (1)
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1
The hospital of Østfold, Kalnes
Grålum, Norway, 1714