Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism - a Randomized Controlled Trial - The REHAB Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pulmonary Embolism
- Sponsor
- Ostfold Hospital Trust
- Enrollment
- 209
- Locations
- 1
- Primary Endpoint
- ISWT
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
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" (PPS).
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). Symptoms are considerable, but less severe than in CTEPH patients. A recent study performed by our group confirmed that up to 50% of our patients complained of various grades of persistent unexplained dyspnea 1-10 years after the diagnosis of PE. In this multifaceted project we wish to evaluate the effect of an eight week rehabilitation program led and supervised by a trained physiotherapist on exercise capacity in PPS patients. This interventional part of the study will be formed as a randomized controlled trial. Patients will be randomized to either usual care or a physiotherapist-supervised rehabilitation program. The study also aims to explore potential underlying pathophysiological mechanisms in PPS, using state of the art methods such as cardiac magnetic resonance imaging and transthoracic echocardiography involving novel methods focusing on the right ventricle. The pathophysiological part of the study will be formed as a case control study, where post PE-patients who do not fulfill the criteria for PPS will serve as controls.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
ISWT
Time Frame: ISWT wil be performed at 12 weeks and 36 weeks after baseline
Change in "Incremental Shuttle Walk Test" will be primary endpoint for interventional part of the study
Secondary Outcomes
- Long term effect of physical capacity(6 months after completing rehabilitation)
- Minimum clinically important difference for ISWT(36 weeks after baseline)
- HRQoL by EQ-5d(12 weeks and 36 weeks after baseline)
- Test-retest reliability of the ISWT in this patient population(At baseline, 12 weeks and 36 weeks)
- mMRC(12 weeks and 36 weeks after inclusion)
- Proportion of patients who achieves the established minimum clinically important difference(36 weeks after baseline)
- Sensewear(12 weeks and 36 weeks after baseline)
- HRQoL by PEmb-QoL(12 weeks and 36 weeks after baseline)