An interventional study of Exercise-based rehabilitation program in Venous Thromboembolism (VTE), Exercise Therapy and Quality of Life (QOL), sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 6 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Prevention
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.
712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.
This study's planned enrollment of 160 is below the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early 6- to 8-week, center-based EBR program, and 2 educational sessions
Other: Exercise-based rehabilitation program
Participants in the control group will receive usual care (i.e., no 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.
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.
Time frame: From baseline to day 90 after randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From baseline to day 90 and to day 180 after randomization
Plan to share: 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)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
Data sharing details ↗ · boris-portal.unibe.ch
Started Dec 2025 (actual). Primary completion is estimated for Mar 2028, 27 months after the start.
Of 65 non-industry interventional studies with no phase under Venous Thromboembolism, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 27 months is below that.
Counting every sponsor, half of 70 studies reached it within 31 months; a quarter within 19 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
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Insel Gruppe AG, University Hospital Bern →