Pulmonary Embolism
Conditions
Keywords
Pulmonary Rehabilitation, Exercise Training, Pulmonary Embolism
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.
Interventions
OTHERRehabilitation
Rehabilitation, exercise training
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
As the control group will undergo rehabilitation after the study period as well, it is possible to blind patients and outcome assessors to the treatment group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Test | within the 6-week study period | change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal workload | within the 6-week study period | change of maximal workload in cycle ergometer tests measured in Watt |
| One-repetition maximum for lower extremities | within the 6-week study period | change of one-repetition maximum for lower extremities measured in kg |
| One-repetition maximum for upper extremities | within the 6-week study period | change of one-repetition maximum for upper extremities measured in kg |
| Maximal inspiratory muscle pressure | within the 6-week study period | change in maximum inspiratory muscle pressure measured in mbar |
| Inspiratory muscle endurance | within the 6-week study period | change in inspiratory muscle endurance measured in seconds |
| peak oxygen consumption | within the 6-week study period | change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry |
| Health related quality of life | within the 6-week study period | change of quality of life measured with the 5-level EQ-5D version (EQ-5D-5L) |
| Disease related quality of life | within the 6-week study period | change of quality of life measured with the Pulmonary Embolism Quality of Life (PEmb-QoL) |
| Functional limitations | within the 6-week study period | change of functional status measured with the patient reported outcomes measurement information system (PROMIS) physical function short form |
| Functional status | within the 6-week study period | change of functional status measured with the post-VTE functional status scale (min: 0, max: 4, lower scores indicate better functional status) |
| Anxiety and depression | within the 6-week study period | change in anxiety and depression measured with the hospital anxiety and depression scale (HADS) |
| Level of dyspnea | within the 6-week study period | change in dyspea at rest and maximal exertion mesured with the medical research council scale and BORG scale |
Countries
Austria
Contacts
Primary ContactStephan Nopp, Dr.
Outcome results
None listed