Pulmonary Embolism Clinical Trial
Official title:
Does an 8-week Home-based Exercise Programme Affect Physical Capacity, Quality of Life, Sick Leave and Use of Psychoactive Drugs in Patients With Pulmonary Embolism. A Randomised Clinical Trial
In a randomised design the study aims to investigate whether an intervention of 8 weeks home-based exercise in addition to usual care can positively influence the physical capacity, quality of life, sick leave and use of psychoactive drugs in patients medically treated for pulmonary embolism.
Background: The existing knowledge regarding pulmonary embolism is primarily focused on the
diagnostic methods and medical treatment of the condition, and furthermore on the short term
prognosis in terms of mortality and complications. Very few studies investigate how every day
life is affected in patients struck by a pulmonary embolism, although many patients display
worries and concerns about their physical, emotional and social well-being after discharge.
For the time being, no rehabilitation options are available for these patients in Denmark.
Methods and materials: 140 patients medically treated for pulmonary embolism will be
recruited from 6 different hospitals. After inclusion the patients will be randomly allocated
to either the control group, receiving usual care, or the intervention group, receiving an
8-week home-based exercise programme in addition to usual care. At the time of inclusion,
after 2 months and after 6 months, the patients' physical capacity is measured using the
Incremental Shuttle Walk test.
Furthermore the patients' complete a questionnaire on quality of life (EQ-5D and Pulmonary
Embolism Quality of Life Questionnaire), self-reported sick leave and use of psychoactive
drugs. All follow-up measurements and visits take place at the hospital from which the
patient was discharged.
Expected outcome and perspective: The investigators expect that the home-based exercise
programme will improve the overall treatment outcome for the patients in the intervention
group. The study will furthermore contribute significantly to the limited knowledge about the
optimal rehabilitation for this group of patients, and may thereby form the basis of future
recommendations in this field.
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