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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
Sponsor:
Collaborators:
University Hospital, Akershus
Ullevaal University Hospital
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Other: Rehabilitation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rehabilitation
Physiotherapist-supervised outpatient rehabilitation program 2 times a week for a total of 8 weeks.
Other: Rehabilitation
Rehabilitation

No Intervention: No rehabilitation
Patients will receive usual care, including information pamphlets with information on the disease and the general importance of exercise.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. mMRC [ Time Frame: 12 weeks and 36 weeks after inclusion ]
    The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale

  2. 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)

  3. HRQoL by EQ-5d [ Time Frame: 12 weeks and 36 weeks after baseline ]
    The effect of rehabilitation on HRQoL measured by EQ-5D

  4. HRQoL by PEmb-QoL [ Time Frame: 12 weeks and 36 weeks after baseline ]
    The effect of rehabilitation on HRQoL measured by PEmb-QoL

  5. 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

  6. 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

  7. 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.

  8. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Øyvind Jervan, MD, PhD 0047698600 oeyjer@so-hf.no

Locations
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Norway
The hospital of Østfold, Kalnes Recruiting
Grålum, Norway, 1714
Contact: Øyvind Jervan    0047698600      
Sponsors and Collaborators
Ostfold Hospital Trust
University Hospital, Akershus
Ullevaal University Hospital
Investigators
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Study Director: Waleed Ghanima, MD. Assoc.Prof Hospital of Østfold, Kalnes

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Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT03405480     History of Changes
Other Study ID Numbers: 2017/1940 (REK)
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ostfold Hospital Trust:
Pulmonary embolism
Dyspnea
Post Pulmonary Embolism Syndrome
PPS
Rehabilitation
Cardiac magnetic resonance imaging (CMR)

Additional relevant MeSH terms:
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Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases