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

August 14, 2019 updated by: Central Jutland Regional Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Herning, Denmark, 7400
        • Regional hospital Herning
      • Silkeborg, Denmark, 8600
        • Diagnostic Centre, Regional Hospital Silkeborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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
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
8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Jutland Regional Hospital

Collaborators

Aalborg University Hospital
Horsens Hospital
Regional Hospital West Jutland

Investigators

  • Principal Investigator: Nanna Rolving, PhD, Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6300001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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