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

Central Jutland Regional Hospital

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Other: 8-week home-based exercise programme

Study type: Interventional

Funder types: Other

Identifiers

NCT02684721

6300001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Exercise group

Experimental group

Description:

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.

Treatment:

Other: 8-week home-based exercise programme