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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
209
Rehabilitation
The hospital of Østfold, Kalnes
Grålum, Norway
ISWT
Change in "Incremental Shuttle Walk Test" will be primary endpoint for interventional part of the study
Time frame: ISWT wil be performed at 12 weeks and 36 weeks after baseline
mMRC
The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale
Time frame: 12 weeks and 36 weeks after inclusion
Sensewear
The effect of PRP on daily physical activity as measured with an activity monitor (Sensewear)
Time frame: 12 weeks and 36 weeks after baseline
HRQoL by EQ-5d
The effect of rehabilitation on HRQoL measured by EQ-5D
Time frame: 12 weeks and 36 weeks after baseline
HRQoL by PEmb-QoL
The effect of rehabilitation on HRQoL measured by PEmb-QoL
Time frame: 12 weeks and 36 weeks after baseline
Long term effect of physical capacity
The long-term effect of rehabilitation on physical capacity measured by ISWT, 6 months after completing the rehabilitation
Time frame: 6 months after completing rehabilitation
Test-retest reliability of the ISWT in this patient population
Test-retest reliability of the ISWT in this patient population
Time frame: At baseline, 12 weeks and 36 weeks
Minimum clinically important difference for ISWT
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Establish the minimum clinically important difference (MID) for the ISWT in patients with PPS expressed in meters.
Time frame: 36 weeks after baseline
Proportion of patients who achieves the established minimum clinically important difference
Proportion of patients who achieves the established minimum clinically important difference for ISWT for this population
Time frame: 36 weeks after baseline