Early Exercise-Based Rehabilitation in Patients Hospitalized for Acute Pulmonary Embolism

NCT07143539 | Recruiting

• 1 other identifier: 2025-01502
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

Brief Summary

Up to half of patients with pulmonary embolism (PE) suffer from impaired quality of life, reduced physical capacity, and symptoms like shortness of breath even three months after diagnosis, despite standard treatment with anticoagulation (blood thinners). The randomized RehabPE trial investigates whether an early, structured rehabilitation program with physical training and patient education can prevent such long-term effects. 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.

Conditions

Venous Thromboembolism (VTE); Exercise Therapy; Quality of Life (QOL); Anxiety Depression; Humans; Exercise Tolerance; Rehabilitation Exercise; Dyspnea; Functional Status; Pulmonary Embolism (Diagnosis)

Keywords

pulmonary embolism; deep vein thrombosis; excercise-based rehabilitation; post-PE syndrome; health-related quality of life; anxiety; depression; dyspnea; impact of early excercise-based rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in generic health-related quality of life (Physical Component Summary score; SF-36)

  Change from baseline to day 90 after randomization in generic healt-related quality of life (HRQoL) assessed by the PCS score of the self-completed SF-36 questionnaire. The SF-36 consists of 36 questions measuring 8 domains (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health) and assesses generic HRQoL during the previous 30 days. The PCS score is obtained from all 8 domains and ranges from 0 to 100.

  From baseline to day 90 after randomization

Secondary Outcomes (9)

• Change in generic health-related quality of life (Physical Component Summary score; SF-36)

  From baseline to day 180 after randomization

• Change in generic health-related quality of life (Mental Component Summary score; SF-36)

  From baseline to day 90 and to day 180 after randomization

• Change in PE-specific health-related quality of life (PEmb-QoL)

  From baseline to day 90 and to day 180 after randomization

• Change in physical exercise capacity (6 minute walking test)

  From baseline to day 90 and to day 180 after randomization

• Change in functional status (Post-VTE Functional Status)

  From baseline to day 90 and to day 180 after randomization

Study Arms (2)

Early exercise-based rehabilitation (EBR)

ACTIVE COMPARATOR

Early 6- to 8-week, center-based EBR program, and 2 educational sessions

Other: Exercise-based rehabilitation program

usual care (no rehabilitation)

NO INTERVENTION

Participants in the control group will receive usual care (i.e., no exercise-based rehabilitation program)

Interventions

Exercise-based rehabilitation program OTHER

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.

Early exercise-based rehabilitation (EBR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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
• Increased risk for post-PE syndrome, defined as simplified Pulmonary Embolism Severity Index (sPESI) ≥1 point at the time of admission
• Written informed consent

You may not qualify if:

• Contraindication to EBR (known unstable cardiac conditions like angina pectoris, severe valvular heart disease, or severe resting pulmonary hypertension)
• Medical condition that clearly precludes participation in EBR (e.g., inability to walk, unstable joints, severe neurological impairment)
• Recently completed (i.e., \<6 months), ongoing, or planned in- or outpatient EBR, or planned supervised outpatient physiotherapy for any indication
• Planned hospitalization during follow-up (e.g., elective surgery or inpatient chemotherapy)
• Contraindication to anticoagulation
• Life expectancy \<1 year based on the treating physician's clinical judgement
• Known pregnancy
• Inability to speak German or French
• Participation in another study that prohibits concurrent participation in RehabPE
• Unable to provide informed consent (e.g., due to dementia)
• Unwilling to provide informed consent
• Prior enrollment in this study

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (5)

Cantonal Hospital Aarau

Aarau, Switzerland

RECRUITING

Cantonal Hospital Baden

Baden, Switzerland

RECRUITING

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, Switzerland

RECRUITING

University Hospital Zürich

Zurich, Switzerland

RECRUITING

Related Publications (20)

• 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.

  PMID: 35820428 BACKGROUND

• 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.

  PMID: 31344319 BACKGROUND

• 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.

  PMID: 28641836 BACKGROUND

• 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.

  PMID: 34976138 BACKGROUND

• 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.

  PMID: 32720853 BACKGROUND

• 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.

  PMID: 30214219 BACKGROUND

• 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.

  PMID: 35345773 BACKGROUND

• 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.

  PMID: 29502109 BACKGROUND

• 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.

  PMID: 32108888 BACKGROUND

• 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.

  PMID: 33867496 BACKGROUND

• 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.

  PMID: 25912176 BACKGROUND

• 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.

  PMID: 37149257 BACKGROUND

• 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.

  PMID: 34419865 BACKGROUND

• 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.

  PMID: 24090607 BACKGROUND

• 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.

  PMID: 28400247 BACKGROUND

• 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.

  PMID: 27932051 BACKGROUND

• 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.

  PMID: 20599368 BACKGROUND

• 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.

  PMID: 34875048 BACKGROUND

• 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.

  PMID: 33548930 BACKGROUND

• 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.

  PMID: 27707980 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Dyspnea; Pulmonary Embolism; Disease; Venous Thrombosis; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Embolism; Pathologic Processes; Thrombosis; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Tobias Tritschler, MD, MSc

  Inselspital, Universitätsspital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Tritschler, MD, MSc

CONTACT

+41 (0)31 632 01 46; tobias.tritschler@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study staff, blinded to participants' study group allocation, will conduct follow-up visit and assessments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 27, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After publication of the study results
• Access Criteria: Data will be publicly available for replication of the study results and secondary data analyses (upon request) in the Bern Open Repository and Information System (BORIS) Research Data.

Locations

CH (5)