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NCT Number: NCT02684721

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

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

8-week home-based exercise programme

Other

8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.

Primary outcomes

  1. Change in Incremental Shuttle Walk test from baseline to 6 months after baseline

    Time frame: Baseline, 2 months and 6 months after baseline

    Validated outcome measure for assessing a person's maximum walking capacity

Secondary outcomes

  1. Change in Pulmonary Embolism Quality of Life from baseline to 6 months

    Time frame: 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.

  2. Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months

    Time frame: Baseline, 2 months and 6 months after baseline

    Generic quality of life questionnaire. Validated in Danish, including Danish preference values

  3. Sick leave in the past 4 weeks measured at 2 and 6 month follow-up

    Time frame: 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.

  4. Average weekly use of psychoactive drugs in the past 4 weeks measured at 2 and 6 month follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Central Jutland Regional Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Horsens Hospital
  • Regional Hospital West Jutland

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 18, 2016
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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