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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.
Aalborg University Hospital
Aalborg, Denmark
Regional hospital Herning
Herning, Denmark
Diagnostic Centre, Regional Hospital Silkeborg
Silkeborg, Denmark
Change in Incremental Shuttle Walk test from baseline to 6 months after baseline
Validated outcome measure for assessing a person's maximum walking capacity
Time frame: Baseline, 2 months and 6 months after baseline
Change in Pulmonary Embolism Quality of Life from baseline to 6 months
Disease specific quality of life questionnaire, developed for patients with pulmonary embolism. Validated in a Scandinavian setting.
Time frame: Baseline, 2 months and 6 months after baseline
Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months
Generic quality of life questionnaire. Validated in Danish, including Danish preference values
Time frame: Baseline, 2 months and 6 months after baseline
Sick leave in the past 4 weeks measured at 2 and 6 month follow-up
The patients are required to state the number of days on sick leave within the last 4 weeks, according to the following categories: No days off work, less than 5 days off work, less than 10 days off work, 10 days or more off work.
Time frame: Baseline, 2 months and 6 months after baseline
Average weekly use of psychoactive drugs in the past 4 weeks measured at 2 and 6 month follow-up
The patients are required to state their average weekly use of psychoactive drugs within the last 4 weeks according to the following categories: No days per week, 1-4 days per week, 5-7 days per week.
Time frame: Baseline, 2 months and 6 months after baseline
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