Pulmonary Embolism Clinical Trial
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
NCT number | NCT02684721 |
Other study ID # | 6300001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2016 |
Est. completion date | September 1, 2018 |
Verified date | November 2016 |
Source | Central Jutland Regional Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | September 1, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital | Aalborg | |
Denmark | Regional hospital Herning | Herning | |
Denmark | Diagnostic Centre, Regional Hospital Silkeborg | Silkeborg |
Lead Sponsor | Collaborator |
---|---|
Central Jutland Regional Hospital | Aalborg University Hospital, Horsens Hospital, Regional Hospital West Jutland |
Denmark,
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 Jun 19. pii: S0049-3848(19)30273-7. doi: 10.1016/j.thromres.2019.06.007. [Epub ahead of print] — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Incremental Shuttle Walk test from baseline to 6 months after baseline | Validated outcome measure for assessing a person's maximum walking capacity | Baseline, 2 months and 6 months after baseline | |
Secondary | 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. | Baseline, 2 months and 6 months after baseline | |
Secondary | Change in EuroQol 5 Dimensions (EQ-5D) from baseline to 6 months | Generic quality of life questionnaire. Validated in Danish, including Danish preference values | Baseline, 2 months and 6 months after baseline | |
Secondary | 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. | Baseline, 2 months and 6 months after baseline | |
Secondary | 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. | Baseline, 2 months and 6 months after baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05050617 -
Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
|
||
Terminated |
NCT04558125 -
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism
|
Phase 4 | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Completed |
NCT03915925 -
Short-term Clinical Deterioration After Acute Pulmonary Embolism
|
||
Completed |
NCT02502396 -
Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
|
||
Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
Completed |
NCT04454554 -
Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
|
||
Completed |
NCT03173066 -
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography
|
Phase 1 | |
Terminated |
NCT03002467 -
Impact Analysis of Prognostic Stratification for Pulmonary Embolism
|
N/A | |
Completed |
NCT02611115 -
Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.
|
N/A | |
Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT01975090 -
The SENTRY Clinical Study
|
N/A | |
Not yet recruiting |
NCT01357941 -
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)
|
N/A | |
Completed |
NCT01326507 -
Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
|
N/A | |
Completed |
NCT00771303 -
Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
|
||
Completed |
NCT00773448 -
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism
|
N/A | |
Completed |
NCT00780767 -
Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism
|
Phase 2 | |
Completed |
NCT02476526 -
Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT00720915 -
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
|
N/A | |
Completed |
NCT00816920 -
Natural History of Isolated Deep Vein Thrombosis of the Calf
|