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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Rehabilitation, exercise training
Therme Wien Med
Vienna, Austria
RECRUITING6-Minute Walk Test
change of walking distance covered within 6 minutes before and after the intervention/control period, measured in meters
Time frame: within the 6-week study period
peak oxygen consumption
change of peak oxygen uptake (VO2/kg/min) measured by lung spiroergometry
Time frame: within the 6-week study period
Maximal workload
change of maximal workload in cycle ergometer tests measured in Watt
Time frame: within the 6-week study period
One-repetition maximum for lower extremities
change of one-repetition maximum for lower extremities measured in kg
Time frame: within the 6-week study period
One-repetition maximum for upper extremities
change of one-repetition maximum for upper extremities measured in kg
Time frame: within the 6-week study period
Maximal inspiratory muscle pressure
change in maximum inspiratory muscle pressure measured in mbar
Time frame: within the 6-week study period
Inspiratory muscle endurance
change in inspiratory muscle endurance measured in seconds
Time frame: 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
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Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: within the 6-week study period
Anxiety and depression
change in anxiety and depression measured with the hospital anxiety and depression scale (HADS)
Time frame: within the 6-week study period