pulmonary embolism venous thromboembolism pulmonary embolism
Conditions
Interventions
One group is subjected to a an 8-week, home-based standardized exercise
training program using a cycle ergometer, supervised
by a board certified physiotherapist, the other group receives a folder wi
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Provision of informed consent prior to any study specific procedures. -Be diagnosed with a confirmed symptomatic acute PE
Exclusion criteria
Exclusion criteria: -Incapability to follow study procedures (including but not limited to participate in the exercise training program, have WiFi at the patients house to connect the cycle ergometer to the platform, or follow instructions of the research team and complete the web-based PROMS). -Life expectancy shorter than 6 months -Presence of settings (e.g. pregnancy) or comorbidities (e.g. planned surgery or cancer with systemic anticancer therapy) requiring intensive treatment that would interfere with the exercise program - Chronic dyspnoea in the setting of known or suspected serious cardiopulmonary comorbidities: CTEPH, COPD >GOLD II, heart failure > New York Heart Association Classification (NYHA) 2 or interstitial lung diseases. - Previous inclusion in the study - COVID associated pulmonary embolism - CWRT >15 minutes at baseline - Contra-indication for Cardiopulmonary Exercise Testing (CPET) conform ATS-guideline (e.g. severe right ventricular strain with massive PE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the relative increase in CWRT (%). Calculated as: (CWRT after intervention [seconds] - CWRT at baseline [seconds]) / CWRT at baseline [seconds]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include PROMS for functional status (post-VTE functional status scale), dyspnea (Medical Research Council [MRC] dyspnea scale), generic QoL (5-level EQ-5D), disease specific QoL (PEmbQoL), exhaustion fatigue (Checklist Individual Strength - fatigue domainseverity subscale), anxiety (Hospital Anxiety and Depression [HADS] scale), Work Productivity (Work Productivity and Activity Index), patient activation engagement in health care (Patient Activation Measure), exercise motivation (Behavioral Regulation and Exercise Questionnaire 2), at 4 weeks, 8 weeks, 3 months and 6 months following randomisation. In addition, we will evaluate and compare the proportion of patients achieving a relevant improvement of the CWRT (>100 seconds absolute improvement), metabolic parameters and Borg scores of the cardiopulmonary exercise test (CPET), level of activity as measured with wearable during the intervention and after 6 months of follow-up, cost effectiveness, and lastly adherence to the exercise program. The main safety outcome involves overall survival, incidence of serious adverse events (SAE) and healthcare utilisation during the study period. | — |
Countries
Netherlands
Contacts
Public ContactF.A. Klok
Leids Universitair Medisch Centrum
Outcome results
None listed