Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism - a Randomized Controlled Trial - The REHAB Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03405480
• Other study ID #: 2017/1940 (REK)
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: March 30, 2024

Study information

• Verified date: November 2023
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 209
• Est. completion date: March 30, 2024
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Other:
• Rehabilitation
Rehabilitation

Locations

Country	Name	City	State
Norway	The hospital of Østfold, Kalnes	Grålum

Sponsors (3)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Ullevaal University Hospital, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Myocardial fibrosis evaluated by cardiac MRI	The primary objective in the pathophysiology part of the study is to investigate whether diffuse myocardial fibrosis shown by CMR is associated with PPS	At baseline
Primary	ISWT	Change in "Incremental Shuttle Walk Test" will be primary endpoint for interventional part of the study	ISWT wil be performed at 12 weeks and 36 weeks after baseline
Secondary	mMRC	The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale	12 weeks and 36 weeks after inclusion
Secondary	Sensewear	The effect of PRP on daily physical activity as measured with an activity monitor (Sensewear)	12 weeks and 36 weeks after baseline
Secondary	HRQoL by EQ-5d	The effect of rehabilitation on HRQoL measured by EQ-5D	12 weeks and 36 weeks after baseline
Secondary	HRQoL by PEmb-QoL	The effect of rehabilitation on HRQoL measured by PEmb-QoL	12 weeks and 36 weeks after baseline
Secondary	Long term effect of physical capacity	The long-term effect of rehabilitation on physical capacity measured by ISWT, 6 months after completing the rehabilitation	6 months after completing rehabilitation
Secondary	Test-retest reliability of the ISWT in this patient population	Test-retest reliability of the ISWT in this patient population	At baseline, 12 weeks and 36 weeks
Secondary	Minimum clinically important difference for ISWT	Establish the minimum clinically important difference (MID) for the ISWT in patients with PPS expressed in meters.	36 weeks after baseline
Secondary	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	36 weeks after baseline