A randomized trial to evaluate a home-based standardized exercise training program for preventing post-pulmonary embolism syndrome

After an acute pulmonary embolism (PE), up to half of patients report persistent dyspnea and/or functional limitations despite adequate anticoagulant treatment. The so-called Post-PE Syndrome (PPES) is characterized by functional limitations and decreased quality of life in PE patients with or without abnormalities in cardiorespiratory function. Etiologies explaining PPES include chronic thromboembolic pulmonary hypertension (CTEPH), chronic thromboembolic pulmonary disease (CTEPD) and chronic right ventricular impairment, but mostly deconditioning. Depressive disorders, fear for complications or recurrences, and post-thrombotic panic syndrome further contribute to long-term functional impairment, which may lead to physical inactivity, subsequent deteriorating deconditioning and a downward spiral as result. Early exercise training likely has positive effects on exercise capacity and quality of life in both PE and CTEPH patients, although adequate quality trials investigating exercise training to prevent PPES are currently unavailble.
In this study we want to determine the effect of an 8-week standardized exercise training program in patients with persistent functional limitations 4 weeks after a diagnosis of acute PE, on physical performance (as assessed by the constant Work Rate cycle Test [CWRT]). Secondary objectives include the incidence of PPES (as assessed with patient reported outcome measures (PROMS) on quality of life (QoL), symptom severity, work productivity, activation, functional limitations and exercise motivation), the difference in physical activity, the cost-effectiveness of the 8-week intervention, and to determine safety of the intervention

we aspect patient who are subjected to a 8-week exercise training program to have an improved endurance, functional performance, QoL and mental state compared to the control group

Visit 1 (phone):
- Check for in and exclusion criteria
- MRC and PVFS questionnaire

Vist 2:
- Obtain informed consent
- CPET
- Wearable

Visit 3:
- CWRT
- Randomization
- PROMS/questionnaires

Visit 4:
- CPET

Visit 5:
- CWRT

Contact physiotherapist before and at 1, 3 and 6 week(s) of the intervention
PROMS/questionnaires will be send (digitally) at 4 weeks, 6 weeks, 3 months and 6 months after randomization

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 with general recommendation on a healthy lifestyle and physical activity.