Clinical trial NCT02684721: Does a Home-based Exercise Programme Affect Physical Capacity and Quality of Life in Patients With Pulmonary Embolism?
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: rehabilitation
physical capacity
quality of life
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Horsens Hospital
name: Regional Hospital West Jutland
First posted: 2016-02-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Incremental Shuttle Walk test from baseline to 6 months after baseline
timeFrame: Baseline, 2 months and 6 months after baseline
Secondary outcomes:
measure: Change in Pulmonary Embolism Quality of Life from baseline to 6 months
timeFrame: Baseline, 2 months and 6 months after baseline
measure: Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months
timeFrame: Baseline, 2 months and 6 months after baseline
measure: Sick leave in the past 4 weeks measured at 2 and 6 month follow-up
timeFrame: Baseline, 2 months and 6 months after baseline
measure: Average weekly use of psychoactive drugs in the past 4 weeks measured at 2 and 6 month follow-up
timeFrame: Baseline, 2 months and 6 months after baseline
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Herning
country: Denmark
facility: Regional hospital Herning
city: Silkeborg
country: Denmark
facility: Diagnostic Centre, Regional Hospital Silkeborg
Study officials:
affiliation: Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark
name: Nanna Rolving, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rolving N, Brocki BC, Mikkelsen HR, Ravn P, Bloch-Nielsen JR, Frost L. Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial. Trials. 2017 May 30;18(1):245. doi: 10.1186/s13063-017-1939-y.
citation: Rolving N, Brocki BC, Andreasen J. Coping with everyday life and physical activity in the aftermath of an acute pulmonary embolism: A qualitative study exploring patients' perceptions and coping strategies. Thromb Res. 2019 Oct;182:185-191. doi: 10.1016/j.thromres.2019.06.007. Epub 2019 Jun 19.
citation: Rolving N, Brocki BC, Bloch-Nielsen JR, Larsen TB, Jensen FL, Mikkelsen HR, Ravn P, Frost L. Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e200064. doi: 10.1001/jamanetworkopen.2020.0064.