Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism
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|ClinicalTrials.gov Identifier: NCT03405480|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Other: Rehabilitation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism - a Randomized Controlled Trial - The REHAB Study|
|Actual Study Start Date :||January 20, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Physiotherapist-supervised outpatient rehabilitation program 2 times a week for a total of 8 weeks.
No Intervention: No rehabilitation
Patients will receive usual care, including information pamphlets with information on the disease and the general importance of exercise.
- 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
- mMRC [ Time Frame: 12 weeks and 36 weeks after inclusion ]The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale
- Sensewear [ Time Frame: 12 weeks and 36 weeks after baseline ]The effect of PRP on daily physical activity as measured with an activity monitor (Sensewear)
- HRQoL by EQ-5d [ Time Frame: 12 weeks and 36 weeks after baseline ]The effect of rehabilitation on HRQoL measured by EQ-5D
- HRQoL by PEmb-QoL [ Time Frame: 12 weeks and 36 weeks after baseline ]The effect of rehabilitation on HRQoL measured by PEmb-QoL
- Long term effect of physical capacity [ Time Frame: 6 months after completing rehabilitation ]The long-term effect of rehabilitation on physical capacity measured by ISWT, 6 months after completing the rehabilitation
- Test-retest reliability of the ISWT in this patient population [ Time Frame: At baseline, 12 weeks and 36 weeks ]Test-retest reliability of the ISWT in this patient population
- Minimum clinically important difference for ISWT [ Time Frame: 36 weeks after baseline ]Establish the minimum clinically important difference (MID) for the ISWT in patients with PPS expressed in meters.
- Proportion of patients who achieves the established minimum clinically important difference [ Time Frame: 36 weeks after baseline ]Proportion of patients who achieves the established minimum clinically important difference for ISWT for this population
- Myocardial fibrosis evaluated by cardiac MRI [ Time Frame: At baseline ]The primary objective in the pathophysiology part of the study is to investigate whether diffuse myocardial fibrosis shown by CMR is associated with PPS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405480
|Contact: Øyvind Jervan, MD, PhDfirstname.lastname@example.org|
|The hospital of Østfold, Kalnes||Recruiting|
|Grålum, Norway, 1714|
|Contact: Øyvind Jervan 0047698600|
|Study Director:||Waleed Ghanima, MD. Assoc.Prof||Hospital of Østfold, Kalnes|