PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

Study Overview
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Brief Summary
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This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism. Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.

Official Title
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Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following: Post-PE functional impairment criteria Post-PE Cardiac Impairment criteria Chronic Thromboembolic Disease criteria Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE Exclusion Criteria: CTEPH diagnosis Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic # Active cancer Pregnancy Myocardial infarction or cardiac surgery one year prior to inclusion Congenital heart disease, congestive heart failure History of stroke Any previous inpatient or outpatient PR Additional criteria that are absolute contraindications for pulmonary rehabilitation Acute and decompensated disease states with severe functional restrictions of various organ systems (e.g. heart, kidney and liver insufficiency, unstable angina pectoris, hemodynamically unstable arrhythmias, acute spinal cord injury, untreated hormonal disorders, acute psychological disorders) open tuberculosis active infectious diseases and acute inflammatory processes Stressful and time-consuming therapy that significantly impair the ability to rehabilitate (e.g. chemotherapy or radiation therapy after malignancy) Participants who are not sufficiently resilient due to physical or mental impairment and / or cannot be mobilized and therefore cannot actively use the rehabilitation facility lack of motivation for therapy massive incontinence drugs and alcohol addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will undergo 6 weeks of outpatient rehabilitation. | Other: Rehabilitation<br>* Rehabilitation, exercise training<br>|
| No Intervention: Control<br>Patients will receive no intervention throughout the 6 weeks period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute Walk Test | change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters | within the 6-week study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak oxygen consumption | change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry | within the 6-week study period | 
| Maximal workload | change of maximal workload in cycle ergometer tests measured in Watt | within the 6-week study period | 
| One-repetition maximum for lower extremities | change of one-repetition maximum for lower extremities measured in kg | within the 6-week study period | 
| One-repetition maximum for upper extremities | change of one-repetition maximum for upper extremities measured in kg | within the 6-week study period | 
| Maximal inspiratory muscle pressure | change in maximum inspiratory muscle pressure measured in mbar | within the 6-week study period | 
| Inspiratory muscle endurance | change in inspiratory muscle endurance measured in seconds | within the 6-week study period | 
| Level of dyspnea | change in dyspea at rest and maximal exertion mesured with the medical research council scale and BORG scale | within the 6-week study period | 
| Health related quality of life | change of quality of life measured with the 5-level EQ-5D version (EQ-5D-5L) | within the 6-week study period | 
| Disease related quality of life | change of quality of life measured with the Pulmonary Embolism Quality of Life (PEmb-QoL) | within the 6-week study period | 
| Functional limitations | change of functional status measured with the patient reported outcomes measurement information system (PROMIS) physical function short form | within the 6-week study period | 
| Functional status | change of functional status measured with the post-VTE functional status scale (min: 0, max: 4, lower scores indicate better functional status) | within the 6-week study period | 
| Anxiety and depression | change in anxiety and depression measured with the hospital anxiety and depression scale (HADS) | within the 6-week study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Training, Pulmonary Rehabilitation, Pulmonary Embolism