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.
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
- Conditions the study is for
- Venous Thromboembolism (VTE), Exercise Therapy, Quality of Life (QOL)
- 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
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
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- 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.
6 sites in 1 country
Switzerland6 sites, 6 recruiting
- 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
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.
- Conditions
- Venous Thromboembolism (VTE), Exercise Therapy, Quality of Life (QOL), Anxiety Depression, Humans, Exercise Tolerance
- 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 group | Role | What they receive |
|---|---|---|
| Early exercise-based rehabilitation (EBR) | Active comparator | Early 6- to 8-week, center-based EBR program, and 2 educational sessions Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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.
- First posted27 Aug 2025
- Study start17 Dec 2025
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Tritschler, Prof. Dr. med., MSc, Principal investigator, Inselspital, Universitätsspital Bern
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 35820428Keller 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 31344319Sista 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 28641836Yu 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 34976138Cires-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 32720853Amoury 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 30214219Gleditsch 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 35345773Albaghdadi 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 29502109Rolving 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 32108888Ghram 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 33867496Lakoski 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 25912176Jervan 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 37149257Boon 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 34419865van 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 24090607Kahn 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