A randomized controlled trial to evaluate the safety and efficacy of an 8-week home-based standardized exercise training program for preventing post-pulmonary embolism syndrome: the PE@HOME study

After 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.

The primary objective of the study is 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

Randomized controlled, open label clinical trial with blinded endpoint
assessment and 6-month follow-up.

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.

All study patients will be subjected to CPET and CWRT before randomisation and
after 8-weeks (4 clinical visits). No other study visits to the clinic
will be necessary since all other outcomes are measured via a web based
dashboard collecting all PROMS during the study, or via
a wearable. The study will not interfere with routine patient care, including
but not limited to anticoagulant treatment and both
frequency and nature of follow-up visits to the outpatient clinic. Patients
randomized to the active treatment arm will receive a cycle
ergometer at home for the duration of the intervention and are asked to comply
to the exercise program. The training will be
remotely supervised by board certified physiotherapist and monitored by the
study coordinator. Patients randomised to the control
arm will be asked to consider the recommendations for a healthy life style
(standard folder of the Dutch Heart Foundation; *Bewegen doet wonderen*) and to
resume their usual physical activity. The study intervention will ask a
considerable effort of the patient, but comes at the expected
benefit of substantial improvement in physical fitness and quality of life. The
risk of adverse events in this study is very low.