Pulmonary EmbolismNCT02684721
Does a Home-based Exercise Programme Affect Physical Capacity and Quality of Life in Patients With Pulmonary Embolism?
A study testing 8-week home-based exercise programme in people with Pulmonary Embolism, run by Central Jutland Regional Hospital at 3 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- 8-week home-based exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Apr 2016to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Objectively verified acute pulmonary embolism
- Treatment with anticoagulant drugs
- 18-70 years of age
- Competency in the Danish language
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Regional hospital Herning
Herning, 7400
Diagnostic Centre, Regional Hospital Silkeborg
Silkeborg, 8600
About this study
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
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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- 8-week home-based exercise programme
- Keywords
- rehabilitation, physical capacity, quality of life
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week home-based exercise programmeOther
8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Exercise group | Experimental | 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. Receives: Other: 8-week home-based exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Incremental Shuttle Walk test from baseline to 6 months after baseline
Validated outcome measure for assessing a person's maximum walking capacity
Measured: Baseline, 2 months and 6 months after baseline
Secondary outcomes (4)
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.
Measured: Baseline, 2 months and 6 months after baseline
Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months
Generic quality of life questionnaire. Validated in Danish, including Danish preference values
Measured: Baseline, 2 months and 6 months after baseline
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.
Measured: 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
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.
Measured: Baseline, 2 months and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start1 Apr 2016
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Horsens Hospital, Regional Hospital West Jutland
- Responsible party
- Sponsor
- Investigators
- Nanna Rolving, PhD, Principal investigator, Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684721
- Sponsor's protocol ID
- 6300001
- Status last verified
- Nov 2016
- First submitted
- 20 Jan 2016
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28558825Rolving 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.
PubMed 31262439Rolving 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.
PubMed 32108888
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02684721
- Acronym / sponsor ID
- 6300001
- Conditions
- Pulmonary Embolism
- Keywords
- rehabilitation, physical capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Horsens Hospital, Regional Hospital West Jutland
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Exercise group | Experimental | Other: 8-week home-based exercise programme8-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Objectively verified acute pulmonary embolism
- Treatment with anticoagulant drugs
- 18-70 years of age
- Competency in the Danish language
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-week home-based exercise programme8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist. | Other | Exercise group |
Primary outcome
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
4 secondary outcomes
Change in Pulmonary Embolism Quality of Life from baseline to 6 months
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Background: PubMed 28558825Rolving 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.
- Background: PubMed 31262439Rolving 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.
- Derived from this study: PubMed 32108888Rolving 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanna Rolving, PhD principal investigator
Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-week home-based exercise programme in people with Pulmonary Embolism, run by Central Jutland Regional Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Incremental Shuttle Walk test from baseline to 6 months after baseline (time frame: Baseline, 2 months and 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02684721, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.