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

Pulmonary Embolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684721
• Other study ID #: 6300001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: September 1, 2018

Study information

• Verified date: November 2016
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Other:
• 8-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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Regional hospital Herning	Herning
Denmark	Diagnostic Centre, Regional Hospital Silkeborg	Silkeborg

Sponsors (4)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital	Aalborg University Hospital, Horsens Hospital, Regional Hospital West Jutland

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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 Jun 19. pii: S0049-3848(19)30273-7. doi: 10.1016/j.thromres.2019.06.007. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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