Rolving Nanna, Brocki Barbara C, Mikkelsen Hanne R, Ravn Pernille, Bloch-Nielsen Jannie Rhod, Frost Lars
University Clinic of Innovative Patient Pathways, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.
Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Aalborg, Denmark.
Trials. 2017 May 30;18(1):245. doi: 10.1186/s13063-017-1939-y.
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.
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.
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.
ClinicalTrials.gov, NCT02684721 . Registered on 20 January 2016.
肺栓塞（PE）的现有证据基础主要集中在诊断方法、药物治疗和预后方面。尽管许多患者出院后在身体和情感上受到负面影响，但只有少数研究调查了PE如何影响日常生活。目前，尚无针对这些患者的有记录的康复方案。我们旨在研究为期8周的居家运动干预是否会影响接受PE药物治疗患者的身体能力、生活质量、病假情况以及精神药物的使用。
将在五家医院招募140例首次发生PE的患者。纳入后，患者将被随机分配到对照组（接受常规护理）或干预组（除常规护理外，还将接受为期8周的居家运动计划）。干预措施包括与物理治疗师进行一次初始的个人运动规划会议，从而制定出建议的运动计划，每周至少进行三次训练，每次持续30 - 60分钟。在为期8周的计划中，患者与物理治疗师保持定期电话联系。在纳入时、2个月后和6个月后，使用递增式往返步行测试测量患者的身体能力。此外，使用自我报告问卷测量患者的生活质量、病假情况以及精神药物的使用情况。在两个随机分组组中，所有随访测量和就诊都将在患者出院的医院进行。合格水平、同意率、依从性和保留率将用作研究可行性的指标。
我们预计居家运动计划将改善干预组患者的身体能力和生活质量。该研究还将极大地有助于填补关于PE患者最佳康复的有限知识空白，并可能因此形成该领域未来建议的基础。
ClinicalTrials.gov，NCT02684721。于2016年1月20日注册。
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