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 wit
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: ? Provision of informed consent prior to any study specific procedures. ? Be diagnosed with a confirmed symptomatic acute PE <4 weeks before randomization ? Be aged 18 years or older ? Report dyspnoea (MRC 2 points or more) and functional limitations (PVFS scale 2 or higher)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: ? 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 training program ? 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 ? If a patient has contra-indication for CPET as determined by the treating physician considering the ATS-guideline
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. | — |
Contacts
Public ContactDieuwke Luijten
LUMC
Outcome results
None listed