Early Exercise-Based Rehabilitation in Patients Hospitalized for Acute Pulmonary Embolism
NCT ID: NCT07143539
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2025-10-31
2028-03-31
Brief Summary
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The study includes hospitalized patients with acute symptomatic PE who are at increased risk of impaired quality of life three months after diagnosis. After informed consent, patients are randomly assigned to one of two groups: one receives an early 6-8-week, center-based rehabilitation program; the other receives standard follow-up care without rehabilitation. The intervention group completes 16-18 outpatient sessions of endurance and strength training, along with two education sessions covering the condition, treatment, and symptom management.
Over 180 days, changes in quality of life, physical exercise capacity, breathlessness, and psychological symptoms, and the time to return to work / usual daily activities will be monitored and compared between groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Early exercise-based rehabilitation (EBR)
Early 6- to 8-week, center-based EBR program, and 2 educational sessions
Exercise-based rehabilitation program
Participants in the intervention group will receive a patient-tailored early (i.e., within 4 weeks of PE diagnosis) EBR program, comprising 16-18 sessions of supervised aerobic exercise and resistance/strength training at local outpatient rehabilitation centers, along with 2 PE-related educational sessions at 2 and 6 weeks of rehabilitation. Participants will receive comprehensive information on the purpose of EBR and each of its components, reassurance on its safety, and education on self-monitoring. Furthermore, physiotherapists will tailor the training based on specific capabilities, focusing on areas of weakness.
usual care (no rehabilitation)
Participants in the control group will receive usual care (i.e., no exercise-based rehabilitation program)
No interventions assigned to this group
Interventions
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Exercise-based rehabilitation program
Participants in the intervention group will receive a patient-tailored early (i.e., within 4 weeks of PE diagnosis) EBR program, comprising 16-18 sessions of supervised aerobic exercise and resistance/strength training at local outpatient rehabilitation centers, along with 2 PE-related educational sessions at 2 and 6 weeks of rehabilitation. Participants will receive comprehensive information on the purpose of EBR and each of its components, reassurance on its safety, and education on self-monitoring. Furthermore, physiotherapists will tailor the training based on specific capabilities, focusing on areas of weakness.
Eligibility Criteria
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Inclusion Criteria
2. Hospitalization for objectively confirmed acute symptomatic PE, defined as intraluminal filling defect of a segmental or more proximal pulmonary artery on computed tomography pulmonary angiography (CTPA) or a high-probability ventilation-perfusion scintigraphy, and admission within the past 7 days
3. Increased risk for post-PE syndrome, defined as simplified Pulmonary Embolism Severity Index (sPESI) ≥1 point at the time of admission
4. Written informed consent
Exclusion Criteria
2. Medical condition that clearly precludes participation in EBR (e.g., inability to walk, unstable joints, severe neurological impairment)
3. Recently completed (i.e., \<6 months), ongoing, or planned in- or outpatient EBR, or planned supervised outpatient physiotherapy for any indication
4. Planned hospitalization during follow-up (e.g., elective surgery or inpatient chemotherapy)
5. Contraindication to anticoagulation
6. Life expectancy \<1 year based on the treating physician's clinical judgement
7. Known pregnancy
8. Inability to speak German or French
9. Participation in another study that prohibits concurrent participation in RehabPE
10. Unable to provide informed consent (e.g., due to dementia)
11. Unwilling to provide informed consent
12. Prior enrollment in this study
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Tobias Tritschler, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Inselspital, Universitätsspital Bern
Locations
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Inselspital, Bern University Hospital
Bern, , Switzerland
Countries
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Central Contacts
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References
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Luijten D, de Jong CMM, Ninaber MK, Spruit MA, Huisman MV, Klok FA. Post-Pulmonary Embolism Syndrome and Functional Outcomes after Acute Pulmonary Embolism. Semin Thromb Hemost. 2023 Nov;49(8):848-860. doi: 10.1055/s-0042-1749659. Epub 2022 Jul 12.
Keller K, Tesche C, Gerhold-Ay A, Nickels S, Klok FA, Rappold L, Hasenfuss G, Dellas C, Konstantinides SV, Lankeit M. Quality of life and functional limitations after pulmonary embolism and its prognostic relevance. J Thromb Haemost. 2019 Nov;17(11):1923-1934. doi: 10.1111/jth.14589. Epub 2019 Aug 13.
Sista AK, Klok FA. Late outcomes of pulmonary embolism: The post-PE syndrome. Thromb Res. 2018 Apr;164:157-162. doi: 10.1016/j.thromres.2017.06.017. Epub 2017 Jun 16.
Yu A, Ding W, Lin W, Cai J, Huang W. Application of pulmonary rehabilitation in patients with pulmonary embolism (Review). Exp Ther Med. 2022 Jan;23(1):96. doi: 10.3892/etm.2021.11019. Epub 2021 Dec 1.
Cires-Drouet RS, Mayorga-Carlin M, Toursavadkohi S, White R, Redding E, Durham F, Dondero K, Prior SJ, Sorkin JD, Lal BK. Safety of exercise therapy after acute pulmonary embolism. Phlebology. 2020 Dec;35(10):824-832. doi: 10.1177/0268355520946625. Epub 2020 Jul 27.
Amoury M, Noack F, Kleeberg K, Stoevesandt D, Lehnigk B, Bethge S, Heinze V, Schlitt A. Prognosis of patients with pulmonary embolism after rehabilitation. Vasc Health Risk Manag. 2018 Aug 30;14:183-187. doi: 10.2147/VHRM.S158815. eCollection 2018.
Gleditsch J, Jervan O, Haukeland-Parker S, Tavoly M, Geier O, Holst R, Klok FA, Johannessen HH, Ghanima W, Hopp E. Effects of pulmonary rehabilitation on cardiac magnetic resonance parameters in patients with persistent dyspnea following pulmonary embolism. Int J Cardiol Heart Vasc. 2022 Mar 23;40:100995. doi: 10.1016/j.ijcha.2022.100995. eCollection 2022 Jun.
Albaghdadi MS, Dudzinski DM, Giordano N, Kabrhel C, Ghoshhajra B, Jaff MR, Weinberg I, Baggish A. Cardiopulmonary Exercise Testing in Patients Following Massive and Submassive Pulmonary Embolism. J Am Heart Assoc. 2018 Mar 3;7(5):e006841. doi: 10.1161/JAHA.117.006841.
Rolving N, Brocki BC, Bloch-Nielsen JR, Larsen TB, Jensen FL, Mikkelsen HR, Ravn P, Frost L. Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e200064. doi: 10.1001/jamanetworkopen.2020.0064.
Ghram A, Jenab Y, Soori R, Choobineh S, Hosseinsabet A, Niyazi S, Shirani S, Shafiee A, Jalali A, Lavie CJ, Wisloff U. High-Intensity Interval Training in Patients with Pulmonary Embolism: A Randomized Controlled Trial. Med Sci Sports Exerc. 2021 Oct 1;53(10):2037-2044. doi: 10.1249/MSS.0000000000002680.
Lakoski SG, Savage PD, Berkman AM, Penalosa L, Crocker A, Ades PA, Kahn SR, Cushman M. The safety and efficacy of early-initiation exercise training after acute venous thromboembolism: a randomized clinical trial. J Thromb Haemost. 2015 Jul;13(7):1238-44. doi: 10.1111/jth.12989. Epub 2015 May 25.
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.
Boon GJAM, Janssen SMJ, Barco S, Bogaard HJ, Ghanima W, Kroft LJM, Meijboom LJ, Ninaber MK, Nossent EJ, Spruit MA, Symersky P, Vliegen HW, Vonk Noordegraaf A, Huisman MV, Siegerink B, Abbink JJ, Klok FA. Efficacy and safety of a 12-week outpatient pulmonary rehabilitation program in Post-PE Syndrome. Thromb Res. 2021 Oct;206:66-75. doi: 10.1016/j.thromres.2021.08.012. Epub 2021 Aug 17.
van Es J, den Exter PL, Kaptein AA, Andela CD, Erkens PM, Klok FA, Douma RA, Mos IC, Cohn DM, Kamphuisen PW, Huisman MV, Middeldorp S. Quality of life after pulmonary embolism as assessed with SF-36 and PEmb-QoL. Thromb Res. 2013 Nov;132(5):500-5. doi: 10.1016/j.thromres.2013.06.016. Epub 2013 Oct 3.
Kahn SR, Akaberi A, Granton JT, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Hernandez P, Aaron SD, Hirsch AM. Quality of Life, Dyspnea, and Functional Exercise Capacity Following a First Episode of Pulmonary Embolism: Results of the ELOPE Cohort Study. Am J Med. 2017 Aug;130(8):990.e9-990.e21. doi: 10.1016/j.amjmed.2017.03.033. Epub 2017 Apr 8.
Kahn SR, Hirsch AM, Akaberi A, Hernandez P, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Geerts WH, Aaron SD, Granton JT. Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Chest. 2017 May;151(5):1058-1068. doi: 10.1016/j.chest.2016.11.030. Epub 2016 Dec 6.
Klok FA, van Kralingen KW, van Dijk AP, Heyning FH, Vliegen HW, Huisman MV. Prevalence and potential determinants of exertional dyspnea after acute pulmonary embolism. Respir Med. 2010 Nov;104(11):1744-9. doi: 10.1016/j.rmed.2010.06.006.
Klok FA, Ageno W, Ay C, Back M, Barco S, Bertoletti L, Becattini C, Carlsen J, Delcroix M, van Es N, Huisman MV, Jara-Palomares L, Konstantinides S, Lang I, Meyer G, Ni Ainle F, Rosenkranz S, Pruszczyk P. Optimal follow-up after acute pulmonary embolism: a position paper of the European Society of Cardiology Working Group on Pulmonary Circulation and Right Ventricular Function, in collaboration with the European Society of Cardiology Working Group on Atherosclerosis and Vascular Biology, endorsed by the European Respiratory Society. Eur Heart J. 2022 Jan 25;43(3):183-189. doi: 10.1093/eurheartj/ehab816.
Boon GJAM, Huisman MV, Klok FA. Determinants and Management of the Post-Pulmonary Embolism Syndrome. Semin Respir Crit Care Med. 2021 Apr;42(2):299-307. doi: 10.1055/s-0041-1722964. Epub 2021 Feb 6.
Sista AK, Miller LE, Kahn SR, Kline JA. Persistent right ventricular dysfunction, functional capacity limitation, exercise intolerance, and quality of life impairment following pulmonary embolism: Systematic review with meta-analysis. Vasc Med. 2017 Feb;22(1):37-43. doi: 10.1177/1358863X16670250. Epub 2016 Oct 5.
Other Identifiers
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2025-01502
Identifier Type: -
Identifier Source: org_study_id
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