Does a Home-based Exercise Programme Affect Physical Capacity and Quality of Life in Patients With Pulmonary Embolism?

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Other: 8-week home-based exercise programme


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients in the control group receive usual care as a minimum. This includes 3-5 days of hospitalisation where the anticoagulant treatment is initiated. The patient and the relatives receive general information about the disease and the course of treatment, the medication and future prevention of embolism. In the year following discharge the patient is booked for a check-up of their anticoagulant treatment with a physician or a nurse as required. | |
| Experimental: Exercise group<br>8-week home-base exercise programme: Patients in the intervention group receive the same usual care as patients in the control group. In addition the patients participate in an 8 week home-based exercise programme, including follow-up telephone calls with the physiotherapist after 1 week, 2 weeks and 4 weeks. Briefly put, the patients are required to exercise for a minimum of 3 times per week for 30-60 minutes, and with 3-4 intervals of approximately 1 minute at a high intensity level. Total exercise time and intervals increase during the 8 week programme. The patients can choose whatever type of exercise they prefer, and they are generally encouraged to choose something they already do, or something that they have previously had positive experiences doing. | Other: 8-week home-based exercise programme<br>* 8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Incremental Shuttle Walk test from baseline to 6 months after baseline | Validated outcome measure for assessing a person's maximum walking capacity | Baseline, 2 months and 6 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | Baseline, 2 months and 6 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, physical capacity, quality of life