Clinical trial NCT04615130: PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome
Official title: Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Pulmonary Rehabilitation
Exercise Training
Pulmonary Embolism
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 6-Minute Walk Test
timeFrame: within the 6-week study period
Secondary outcomes:
measure: peak oxygen consumption
timeFrame: within the 6-week study period
measure: Maximal workload
timeFrame: within the 6-week study period
measure: One-repetition maximum for lower extremities
timeFrame: within the 6-week study period
measure: One-repetition maximum for upper extremities
timeFrame: within the 6-week study period
measure: Maximal inspiratory muscle pressure
timeFrame: within the 6-week study period
measure: Inspiratory muscle endurance
timeFrame: within the 6-week study period
measure: Level of dyspnea
timeFrame: within the 6-week study period
measure: Health related quality of life
timeFrame: within the 6-week study period
measure: Disease related quality of life
timeFrame: within the 6-week study period
measure: Functional limitations
timeFrame: within the 6-week study period
measure: Functional status
timeFrame: within the 6-week study period
measure: Anxiety and depression
timeFrame: within the 6-week study period
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Therme Wien Med
Study officials:
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.