Anxiety Depression, Dyspnea, Exercise Therapy, Exercise Tolerance, Functional Status, Humans, Pulmonary Embolism (Diagnosis), Quality of Life (QOL), Rehabilitation Exercise, Venous Thromboembolism (VTE)
Conditions
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
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.
Interventions
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.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Study staff, blinded to participants' study group allocation, will conduct follow-up visit and assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 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
1. Contraindication to EBR (known unstable cardiac conditions like angina pectoris, severe valvular heart disease, or severe resting pulmonary hypertension) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in generic health-related quality of life (Physical Component Summary score; SF-36) | From baseline to day 90 after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in generic health-related quality of life (Physical Component Summary score; SF-36) | From baseline to day 180 after randomization | 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. |
| 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 | 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. |
| Change in PE-specific health-related quality of life (PEmb-QoL) | From baseline to day 90 and to day 180 after randomization | 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. |
| Change in physical exercise capacity (6 minute walking test) | From baseline to day 90 and to day 180 after randomization | 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. |
| Change in functional status (Post-VTE Functional Status) | From baseline to day 90 and to day 180 after randomization | 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 to return to work (workers) or usual activities of daily living (non-workers) | For the duration of the study: 180 days | 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. |
| Change in dyspnea | From baseline to day 90 and to day 180 after randomization | 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). |
| Change in symptoms of anxiety (GAD-7) | From baseline to day 90 and to day 180 after randomization | Change in symptoms of anxiety will be assessed by the self-completed General Anxiety Disorder 7 (GAD-7) ranging from 0 to 21 points. |
| Change in symptoms of depression (PHQ-9) | From baseline to day 90 and to day 180 after randomization | Change in symptoms of depression will be assessed by the self-completed Patient Health Questionnaire 9 (PHQ-9), ranging from 0 to 27 points. |
Countries
Switzerland
Contacts
CONTACTTobias Tritschler, Prof. Dr. med., MSc
PRINCIPAL_INVESTIGATORTobias Tritschler, Prof. Dr. med., MSc
Inselspital, Universitätsspital Bern
Outcome results
None listed