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.
BACKGROUND
The existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE.


METHODS
One hundred forty patients with incident first-time PE will be recruited in five hospitals. After inclusion, patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, who will be exposed to an 8-week home-based exercise program in addition to usual care. The intervention includes an initial individual exercise planning session with a physiotherapist, leading to a recommended exercise program of a minimum of three weekly training sessions of 30-60 minutes' duration. The patients have regular telephone contact with the physiotherapist during the 8-week program. 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' quality of life, sick leave, and use of psychotropic drugs is measured using self-reported questionnaires. In both randomization arms, all follow-up measurements and visits will take place at the hospital from which the patient was discharged. Levels of eligibility, consent, adherence, and retention will be used as indicators of study feasibility.


DISCUSSION
We expect that the home-based exercise program will improve the physical capacity and quality of life for the patients in the intervention group. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation of PE patients, and may thereby form the basis of future recommendations in this field.


TRIAL REGISTRATION
ClinicalTrials.gov, NCT02684721 . Registered on 20 January 2016.
['Rolving|Nanna|N|0000-0001-9195-7278', 'Brocki|Barbara C|BC|', 'Mikkelsen|Hanne R|HR|', 'Ravn|Pernille|P|', 'Bloch-Nielsen|Jannie Rhod|JR|', 'Frost|Lars|L|']
D000041:Absenteeism D002985:Clinical Protocols D003718:Denmark D005081:Exercise Therapy D017079:Exercise Tolerance D005240:Feasibility Studies D006304:Health Status D006699:Home Care Services D006801:Humans D008603:Mental Health D010351:Patient Discharge D011619:Psychotropic Drugs D011655:Pulmonary Embolism D011788:Quality of Life D020127:Recovery of Function D012107:Research Design D018582:Sick Leave D011795:Surveys and Questionnaires D013997:Time Factors D016896:Treatment Outcome D000070857:Walk Test
Exercise Pulmonary embolism Study protocol Randomized clinical trial Multicenter study