Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism
- Conditions
- Pulmonary Embolism
- Interventions
- Other: Rehabilitation
- Registration Number
- NCT03405480
- Lead Sponsor
- Ostfold Hospital Trust
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 209
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rehabilitation Rehabilitation Physiotherapist-supervised outpatient rehabilitation program 2 times a week for a total of 8 weeks.
- Primary Outcome Measures
Name Time Method ISWT 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 Outcome Measures
Name Time Method HRQoL by EQ-5d 12 weeks and 36 weeks after baseline The effect of rehabilitation on HRQoL measured by EQ-5D
Long term effect of physical capacity 6 months after completing rehabilitation The long-term effect of rehabilitation on physical capacity measured by ISWT, 6 months after completing the rehabilitation
Minimum clinically important difference for ISWT 36 weeks after baseline Establish the minimum clinically important difference (MID) for the ISWT in patients with PPS expressed in meters.
Test-retest reliability of the ISWT in this patient population At baseline, 12 weeks and 36 weeks Test-retest reliability of the ISWT in this patient population
mMRC 12 weeks and 36 weeks after inclusion The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale
Proportion of patients who achieves the established minimum clinically important difference 36 weeks after baseline Proportion of patients who achieves the established minimum clinically important difference for ISWT for this population
Sensewear 12 weeks and 36 weeks after baseline The effect of PRP on daily physical activity as measured with an activity monitor (Sensewear)
HRQoL by PEmb-QoL 12 weeks and 36 weeks after baseline The effect of rehabilitation on HRQoL measured by PEmb-QoL
Trial Locations
- Locations (1)
The hospital of Østfold, Kalnes
🇳🇴Grålum, Norway