Pulmonary Embolism
Conditions
Keywords
rehabilitation, physical capacity, quality of life
Brief summary
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.
Detailed description
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.
Interventions
OTHER8-week home-based exercise programme
8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.
Sponsors
Aalborg University Hospital
Horsens Hospital
Regional Hospital West Jutland
Central Jutland Regional Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Objectively verified acute pulmonary embolism * Treatment with anticoagulant drugs * 18-70 years of age * Competency in the Danish language
Exclusion criteria
* Pulmonary embolism as a secondary finding in relation to scan performed due to another disease. * Severe co-morbidity (malignant, inflammatory or psychiatric) * Unable to perform the Incremental Shuttle Walk test for other reasons (e.g. amputation or intermittent claudication).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Incremental Shuttle Walk test from baseline to 6 months after baseline | Baseline, 2 months and 6 months after baseline | Validated outcome measure for assessing a person's maximum walking capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Embolism Quality of Life from baseline to 6 months | Baseline, 2 months and 6 months after baseline | Disease specific quality of life questionnaire, developed for patients with pulmonary embolism. Validated in a Scandinavian setting. |
| Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months | Baseline, 2 months and 6 months after baseline | Generic quality of life questionnaire. Validated in Danish, including Danish preference values |
| Sick leave in the past 4 weeks measured at 2 and 6 month follow-up | Baseline, 2 months and 6 months after baseline | 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. |
| Average weekly use of psychoactive drugs in the past 4 weeks measured at 2 and 6 month follow-up | Baseline, 2 months and 6 months after baseline | 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. |
Countries
Denmark
Outcome results
None listed