Clinical trial NCT03405480: Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism
Official title: Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism - a Randomized Controlled Trial - The REHAB Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism
Dyspnea
Post Pulmonary Embolism Syndrome
PPS
Rehabilitation
Cardiac magnetic resonance imaging (CMR)
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: Ullevaal University Hospital
First posted: 2018-01-23
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: ISWT
timeFrame: ISWT wil be performed at 12 weeks and 36 weeks after baseline
Secondary outcomes:
measure: mMRC
timeFrame: 12 weeks and 36 weeks after inclusion
measure: Sensewear
timeFrame: 12 weeks and 36 weeks after baseline
measure: HRQoL by EQ-5d
timeFrame: 12 weeks and 36 weeks after baseline
measure: HRQoL by PEmb-QoL
timeFrame: 12 weeks and 36 weeks after baseline
measure: Long term effect of physical capacity
timeFrame: 6 months after completing rehabilitation
measure: Test-retest reliability of the ISWT in this patient population
timeFrame: At baseline, 12 weeks and 36 weeks
measure: Minimum clinically important difference for ISWT
timeFrame: 36 weeks after baseline
measure: Proportion of patients who achieves the established minimum clinically important difference
timeFrame: 36 weeks after baseline
Other outcomes:
measure: Myocardial fibrosis evaluated by cardiac MRI
timeFrame: At baseline
Locations:
city: Grålum
country: Norway
facility: The hospital of Østfold, Kalnes
Study officials:
affiliation: Hospital of Østfold, Kalnes
name: Waleed Ghanima, MD. Assoc.Prof
role: STUDY_DIRECTOR
References:
citation: Fabyan KD, Holley AB. Postpulmonary embolism syndrome. Curr Opin Pulm Med. 2021 Sep 1;27(5):335-341. doi: 10.1097/MCP.0000000000000789.
citation: Haukeland-Parker S, Jervan O, Johannessen HH, Gleditsch J, Stavem K, Steine K, Spruit MA, Holst R, Tavoly M, Klok FA, Ghanima W. Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial. Trials. 2021 Jan 6;22(1):22. doi: 10.1186/s13063-020-04940-9.