Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02684721
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : August 19, 2019
Sponsor:
Collaborators:
Aalborg University Hospital
Horsens Hospital
Regional Hospital West Jutland
Information provided by (Responsible Party):
Central Jutland Regional Hospital

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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Other: 8-week home-based exercise programme Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684721


Locations
Layout table for location information
Denmark
Aalborg University Hospital
Aalborg, Denmark, 9000
Regional hospital Herning
Herning, Denmark, 7400
Diagnostic Centre, Regional Hospital Silkeborg
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Central Jutland Regional Hospital
Aalborg University Hospital
Horsens Hospital
Regional Hospital West Jutland
Investigators
Layout table for investigator information
Principal Investigator: Nanna Rolving, PhD Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark

Publications:
Layout table for additonal information
Responsible Party: Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT02684721     History of Changes
Other Study ID Numbers: 6300001
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: November 2016
Keywords provided by Central Jutland Regional Hospital:
rehabilitation
physical capacity
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases