search
Back to results

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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
8-week home-based exercise programme
Sponsored by
Central Jutland Regional Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring rehabilitation, physical capacity, quality of life

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Aalborg University Hospital
  • Regional hospital Herning
  • Diagnostic Centre, Regional Hospital Silkeborg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Incremental Shuttle Walk test from baseline to 6 months after baseline
Validated outcome measure for assessing a person's maximum walking capacity

Secondary Outcome Measures

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.
Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months
Generic quality of life questionnaire. Validated in Danish, including Danish preference values
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.
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.

Full Information

First Posted
January 20, 2016
Last Updated
August 14, 2019
Sponsor
Central Jutland Regional Hospital
Collaborators
Aalborg University Hospital, Horsens Hospital, Regional Hospital West Jutland
search

1. Study Identification

Unique Protocol Identification Number
NCT02684721
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Jutland Regional Hospital
Collaborators
Aalborg University Hospital, Horsens Hospital, Regional Hospital West Jutland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
rehabilitation, physical capacity, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
8-week home-based exercise programme
Intervention Description
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 Measure Information:
Title
Change in Incremental Shuttle Walk test from baseline to 6 months after baseline
Description
Validated outcome measure for assessing a person's maximum walking capacity
Time Frame
Baseline, 2 months and 6 months after baseline
Secondary Outcome Measure Information:
Title
Change in Pulmonary Embolism Quality of Life from baseline to 6 months
Description
Disease specific quality of life questionnaire, developed for patients with pulmonary embolism. Validated in a Scandinavian setting.
Time Frame
Baseline, 2 months and 6 months after baseline
Title
Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months
Description
Generic quality of life questionnaire. Validated in Danish, including Danish preference values
Time Frame
Baseline, 2 months and 6 months after baseline
Title
Sick leave in the past 4 weeks measured at 2 and 6 month follow-up
Description
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.
Time Frame
Baseline, 2 months and 6 months after baseline
Title
Average weekly use of psychoactive drugs in the past 4 weeks measured at 2 and 6 month follow-up
Description
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.
Time Frame
Baseline, 2 months and 6 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanna Rolving, PhD
Organizational Affiliation
Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Regional hospital Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Diagnostic Centre, Regional Hospital Silkeborg
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28558825
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.
Results Reference
background
PubMed Identifier
31262439
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.
Results Reference
background
PubMed Identifier
32108888
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs