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| Name | Class |
|---|---|
| University Hospital, Akershus | OTHER |
| Ullevaal University Hospital | OTHER |
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This project aims to evaluate a rehabilitation program as treatment and uncover potential pathophysiological mechanisms of a newly identified chronic condition named "Post Pulmonary Embolism Syndrome" (PPS).
The newly identified Post Pulmonary Embolism Syndrome (PPS) is characterized by chronic persistent, but unexplained dyspnea (i.e. without signs of pulmonary hypertension or pulmonary abnormality). Symptoms are considerable, but less severe than in CTEPH patients. A recent study performed by our group confirmed that up to 50% of our patients complained of various grades of persistent unexplained dyspnea 1-10 years after the diagnosis of PE.
In this multifaceted project we wish to evaluate the effect of an eight week rehabilitation program led and supervised by a trained physiotherapist on exercise capacity in PPS patients. This interventional part of the study will be formed as a randomized controlled trial. Patients will be randomized to either usual care or a physiotherapist-supervised rehabilitation program.
The study also aims to explore potential underlying pathophysiological mechanisms in PPS, using state of the art methods such as cardiac magnetic resonance imaging and transthoracic echocardiography involving novel methods focusing on the right ventricle. The pathophysiological part of the study will be formed as a case control study, where post PE-patients who do not fulfill the criteria for PPS will serve as controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation | Experimental | Physiotherapist-supervised outpatient rehabilitation program 2 times a week for a total of 8 weeks. |
|
| No rehabilitation | No Intervention | Patients will receive usual care, including information pamphlets with information on the disease and the general importance of exercise. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Other | Rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| ISWT | Change in "Incremental Shuttle Walk Test" will be primary endpoint for interventional part of the study | ISWT wil be performed at 12 weeks and 36 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| mMRC | The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale | 12 weeks and 36 weeks after inclusion |
| Sensewear | The effect of PRP on daily physical activity as measured with an activity monitor (Sensewear) |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial fibrosis evaluated by cardiac MRI | The primary objective in the pathophysiology part of the study is to investigate whether diffuse myocardial fibrosis shown by CMR is associated with PPS | At baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waleed Ghanima, MD. Assoc.Prof | Hospital of Østfold, Kalnes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The hospital of Østfold, Kalnes | Grålum | 1714 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41623859 | Derived | Dhayyat A, Stavem K, Jervan O, Hilde JM, Rashid D, Gleditsch J, Ghanima W, Steine K. Stress Echocardiography to Detect Exercise Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Disease. Pulm Med. 2026 Jan 28;2026:4127338. doi: 10.1155/pm/4127338. eCollection 2026. | |
| 37356172 | Derived |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D004417 | Dyspnea |
| 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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| 12 weeks and 36 weeks after baseline |
| HRQoL by EQ-5d | The effect of rehabilitation on HRQoL measured by EQ-5D | 12 weeks and 36 weeks after baseline |
| HRQoL by PEmb-QoL | The effect of rehabilitation on HRQoL measured by PEmb-QoL | 12 weeks and 36 weeks after baseline |
| Long term effect of physical capacity | The long-term effect of rehabilitation on physical capacity measured by ISWT, 6 months after completing the rehabilitation | 6 months after completing rehabilitation |
| Test-retest reliability of the ISWT in this patient population | Test-retest reliability of the ISWT in this patient population | At baseline, 12 weeks and 36 weeks |
| Minimum clinically important difference for ISWT | Establish the minimum clinically important difference (MID) for the ISWT in patients with PPS expressed in meters. | 36 weeks after baseline |
| Proportion of patients who achieves the established minimum clinically important difference | Proportion of patients who achieves the established minimum clinically important difference for ISWT for this population | 36 weeks after baseline |
| Jervan O, Dhayyat A, Gleditsch J, Haukeland-Parker S, Tavoly M, Klok FA, Rashid D, Stavem K, Ghanima W, Steine K. Demographic, clinical, and echocardiographic factors associated with residual perfusion defects beyond six months after pulmonary embolism. Thromb Res. 2023 Sep;229:7-14. doi: 10.1016/j.thromres.2023.06.004. Epub 2023 Jun 17. |
| 37149257 | Derived | Jervan O, Haukeland-Parker S, Gleditsch J, Tavoly M, Klok FA, Steine K, Johannessen HH, Spruit MA, Atar D, Holst R, Astrup Dahm AE, Sirnes PA, Stavem K, Ghanima W. The Effects of Exercise Training in Patients With Persistent Dyspnea Following Pulmonary Embolism: A Randomized Controlled Trial. Chest. 2023 Oct;164(4):981-991. doi: 10.1016/j.chest.2023.04.042. Epub 2023 May 5. |
| 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. |
| 33407792 | Derived | Haukeland-Parker S, Jervan O, Johannessen HH, Gleditsch J, Stavem K, Steine K, Spruit MA, Holst R, Tavoly M, Klok FA, Ghanima W. Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial. Trials. 2021 Jan 6;22(1):22. doi: 10.1186/s13063-020-04940-9. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |