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Venous Thromboembolism (VTE)RehabPENCT07143539

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

A study testing Exercise-based rehabilitation program in people with Venous Thromboembolism (VTE) and Exercise Therapy, run by Insel Gruppe AG, University Hospital Bern at 6 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exercise-based rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
6 sitesSwitzerland
Study dates
17 Dec 2025to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tobias Tritschler, Prof. Dr. med., MSc contact

+41 (0)31 632 01 46

tobias.tritschler@insel.ch

6 sites in 1 country

Switzerland6 sites, 6 recruiting

  • Cantonal Hospital Aarau

    Aarau

    Philipp Schütz, Prof. Dr. med., +41 (0)62 838 95 24, philipp.schuetz@ksa.ch

    Recruiting

  • Cantonal Hospital Baden

    Baden

    Maria Wertli, Prof. Dr. med., +41 (0)56 486 25 02, maria.wertli@ksb.ch

    Recruiting

  • Inselspital, Bern University Hospital

    Bern, 3010

    Tobias Tritschler, Prof. Dr. med., MSc, +41 (0)31 632 01 46, tobias.tritschler@insel.ch

    Recruiting

  • Geneva University Hospitals

    Geneva

    Marc Righini, Prof. Dr. med., +41 (0)22 372 92 94, marc.righini@hug.ch

    Recruiting

  • Lausanne University Hospital

    Lausanne

    Marie Méan, PD, MD, +41 (0)79 556 69 17, marie.mean@chuv.ch

    Recruiting

  • University Hospital Zürich

    Zurich

    Stefano Barco, Prof. Dr. med. et phil., +41 (0)43 253 11 50, stefano.barco@usz.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Early Exercise-based Rehabilitation in High-risk Patients Hospitalized for Acute Pulmonary Embolism: a Pragmatic Multicenter Randomized Partially Blinded Superiority Trial

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.

Being tested
Exercise-based rehabilitation program
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
Medical subject headings
Venous Thromboembolism, Dyspnea, Pulmonary Embolism, Disease, Venous Thrombosis, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise-based rehabilitation programOther

    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.

Study groups in NCT07143539
Study groupRoleWhat they receive
Early exercise-based rehabilitation (EBR)Active comparatorEarly 6- to 8-week, center-based EBR program, and 2 educational sessions
Receives: Other: Exercise-based rehabilitation program
usual care (no rehabilitation)No interventionParticipants in the control group will receive usual care (i.e., no exercise-based rehabilitation program)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to day 90 after randomization

Secondary outcomes (9)

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

    Change from baseline to day 180 after randomization in the SF-36 Physical Component Summary score, ranging from 0 to 100 with higher scores indicating better HRQoL.

    Measured: From baseline to day 180 after randomization

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

    Changes from baseline to day 90 and to day 180 after randomization in the SF-36 Mental Component Summary score, ranging from 0 to 100 with higher scores indicating better HRQoL.

    Measured: From baseline to day 90 and to day 180 after randomization

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

    Change from baseline to day 90 and to day 180 after randomization in PE-specific health-realted quality of life assessed by the self-completed PEmb-QoL questionnaire, which comprises 9 questions covering 6 domains, with scores ranging from 0 to 100. Total scores will be calculated based on the average of scores of all 6 domains.

    Measured: From baseline to day 90 and to day 180 after randomization

  4. Change in physical exercise capacity (6 minute walking test)

    Change in physical exercise capacity from baseline to day 90 and to day 180 after randomization will be measured by the 6 minute walking test (6MWT). Participants will be asked to walk as far as possible in 6 minutes along a flat corridor of at least 30 mesters under supervision, and the distance in meters will determine the 6MWD.

    Measured: From baseline to day 90 and to day 180 after randomization

  5. Change in functional status (Post-VTE Functional Status)

    Change in functional status will be assessed by the Post-VTE Functional Status scale, where patients will grade their functional status on a scale ranging from 0 (no limitations due to VTE symptoms) to 4 (depending on assistance in activities of daily living due to VTE symptoms).

    Measured: From baseline to day 90 and to day 180 after randomization

  6. Time to return to work (workers) or usual activities of daily living (non-workers)

    Time (days) to return to work in workers or to usual activities of daily living in non-workers will be obtained based on information from patient interviews.

    Measured: For the duration of the study: 180 days

  7. Change in dyspnea

    Dyspnea will be measured based on information from patient interviews, using the NYHA classification, ranging from 1 (no limitation of physical activity due to shortness of breath) to 4 (unable to carry on any physical activity without shortness of breath).

    Measured: From baseline to day 90 and to day 180 after randomization

  8. Change in symptoms of anxiety (GAD-7)

    Change in symptoms of anxiety will be assessed by the self-completed General Anxiety Disorder 7 (GAD-7) ranging from 0 to 21 points.

    Measured: From baseline to day 90 and to day 180 after randomization

  9. Change in symptoms of depression (PHQ-9)

    Change in symptoms of depression will be assessed by the self-completed Patient Health Questionnaire 9 (PHQ-9), ranging from 0 to 27 points.

    Measured: From baseline to day 90 and to day 180 after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start17 Dec 2025
  3. Primary completionMar 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07143539
Sponsor's protocol ID
2025-01502
Other IDs
2025
Acronym
RehabPE
Status last verified
Jun 2026
First submitted
19 Aug 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of the study results, an anonymized data set relating to the primary publication along with the latest version of the study protocol, the informed consent form, the statistical analysis plan, and the code used for the analyses will be made 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, an online non-commercial data repository that meets Swiss National Science Foundation requirements for FAIR Data Principles (www.force11.org/group/fairgroup/fairprinciples)

Publications

  • 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.

    PubMed 35820428

  • 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.

    PubMed 31344319

  • 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.

    PubMed 28641836

  • 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.

    PubMed 34976138

  • 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.

    PubMed 32720853

  • 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.

    PubMed 30214219

  • 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.

    PubMed 35345773

  • 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.

    PubMed 29502109

  • 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.

    PubMed 32108888

  • 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.

    PubMed 33867496

  • 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.

    PubMed 25912176

  • 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.

    PubMed 37149257

  • 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.

    PubMed 34419865

  • 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.

    PubMed 24090607

  • 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.

    PubMed 28400247

Questions about this trial

What is this clinical trial studying?

A study testing Exercise-based rehabilitation program in people with Venous Thromboembolism (VTE) and Exercise Therapy, run by Insel Gruppe AG, University Hospital Bern at 6 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tobias Tritschler, Prof. Dr. med., MSc (+41 (0)31 632 01 46, tobias.tritschler@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in generic health-related quality of life (Physical Component Summary score; SF-36) (time frame: From baseline to day 90 after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07143539, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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