Effect of an 8-week Supervised Exercise Programme on Physical Capacity and Quality of Life in Patients With Pulmonary Embolism. A Randomised Clinical Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- VO2 max
研究概览
简要总结
In a randomized controlled design the study aims to investigate whether an intervention of 8 weeks supervised bicycle training program in addition to usual care can positively influence the physical capacity and quality of life in patients medically treated for pulmonary embolism.
详细描述
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. Few studies have investigated the effect of exercise training on physical capacity and quality of life in patients struck by a pulmonary embolism, although many patients display worries and concerns about their physical and psychological wellbeing after discharge. Furthermore, a number of cross sectional studies and cohort studies have found some patients to have long-term reduced physical capacity and reduced quality of life following pulmonary embolism.
For the time being, no rehabilitation options are available for these patients neither in Denmark, or internationally. As no research exists regarding rehabilitation and exercise for these patients, the study will contribute with important knowledge in terms of what kind of exercise and physical tests we should provide in the future.
Methods and materials:
30 patients medically treated for pulmonary embolism will be recruited from three different hospitals. After inclusion and performance of baseline tests, the patients will be randomly allocated to either the control group, receiving standard care, or the intervention group, receiving an eight-week supervised interval training program in addition to standard care. At the time of inclusion and at the end of the training program (eight-weeks), the patient's physical capacity is measured using Vo2 Max test on an ergometer cycle and by the Incremental shuttle walk test. Furthermore, the patients complete a questionnaire on quality of life (Pulmonary Embolism Quality of Life Questionnaire and Euro-Qol 5 Dimensions), and also, daily physical activity during 7 days will be measured using accelerometry the week prior to baseline test, and the week following the 8-week test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Due to the intervention (exercise versus usual care) patients and trainers cannot be masked. Outcome assessors will be masked, as it will be different persons performing the 8-week follow-up, who have no knowledge of the group allocation. Furthermore, nurses and doctors providing usual care for the patients at the cardiologic departments are masked for group allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Objective verified acute pulmonary embolism (ICD10 I260 and ICD10 I269), recurrent included.
- •Currently treated with anticoagulation medicine.
- •18-80 years.
- •Speaking and understanding Danish.
排除标准
- •Pulmonary embolism found as a secondary finding scanning for other diseases.
- •In combination with severe comorbidity (e.g. cancer, COPD, heart disease, psychiatric disease like schizophrenia or bipolar disorder), pregnancy or being unable to complete Watt-max test and incremental shuttle walk test.
结局指标
主要结局
VO2 max
时间窗: Change from baseline test to 8 week follow-up (pre- to post-test)
Change in physical capacity measured as VO2 max during watt-max test (cycle ergometer)
次要结局
- Pulmonary Embolism Quality of Life(Change in score from baseline to 8 week follow-up)
- EuroQol 5 Dimensions(Change in score from baseline to 8 week follow-up)
- Incremental Shuttle-Walk Test(Change in number of meters walked from baseline to 8 week follow-up)
- Average physical activity(Change in average daily physical activity (7 days) from baseline to 8 week follow-up)