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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients will undergo 6 weeks of outpatient rehabilitation. |
|
| Control | No Intervention | Patients will receive no intervention throughout the 6 weeks period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Other | Rehabilitation, exercise training |
|
| 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 |
| 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 |
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Inclusion Criteria:
Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:
Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE
Exclusion Criteria:
Additional criteria that are absolute contraindications for pulmonary rehabilitation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephan Nopp, Dr. | Contact | +43 40400 44170 | stephan.nopp@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therme Wien Med | Recruiting | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34127618 | Derived | Fabyan KD, Holley AB. Postpulmonary embolism syndrome. Curr Opin Pulm Med. 2021 Sep 1;27(5):335-341. doi: 10.1097/MCP.0000000000000789. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2022 | May 6, 2022 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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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.
| 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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |