Hot Water Immersion in Rehabilitation After Myocardial Infarction (HOT-MI) - a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Concentrations of interleukin 6 (IL-6) in blood
研究概览
简要总结
Myocardial infarction (MI) is a leading cause of death in developed countries, including Sweden. Standard treatment for patients after MI includes exercise-based cardiac rehabilitation which contributes to improved cardiovascular function and reduces the risk of hospital readmissions, new cardiovascular events and mortality. Thermotherapy may also have beneficial effects on cardiovascular disease by a reduction in inflammatory status and improved metabolism and vascular function. Given the well-documented effects of exercise training on cardiac rehabilitation and recent evidence that thermotherapy may improve cardiovascular function, we wish to investigate the effect of exercise combined with hot water immersion (HWI) in cardiac rehabilitation post-MI.
This is a single-centre, randomized controlled clinical trial in patients with recent MI. Our aim is to investigate whether exercise training combined with HWI improves inflammatory and metabolic status, cardiovascular function as well as psychological well-being, compared with exercise training alone. Patients will be randomized 1:1 to an 8 week intervention with exercise training 2 times per week followed by 15 minutes of hot water immersion, or to a control group with exercise training alone. The primary endpoint is changes in the inflammatory marker interleukin (IL-) 6 between groups at 8 weeks. Secondary endpoints include other biomarkers of inflammation, metabolism, effects on cardiovascular function and psychological benefits.
Secondary prevention after MI has improved during the last decades but readmissions and death following acute MI remain large health challenges. If HWI in addition to standard cardiac rehabilitation can lower inflammation more than standard therapy alone, and improve metabolic, cardiovascular and psychological status, it could be a cost-effective and safe complementary strategy for secondary prevention after MI, particularly for those with limited exercise capability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of ST-elevation myocardial infarction (STEMI) or non-STEMI
- •Concomitant participation in standard care exercise-based cardiac rehabilitation
- •Male or female patients ≥ 18 years
- •Written informed consent
排除标准
- •Regularly performing hot water immersion, sauna or other types of thermotherapy
- •Not willing to perform hot water immersion regularly
- •Febrile illness or acute, ongoing infection
- •<18 years of age
- •Inability to provide informed consent
研究组 & 干预措施
Hot water immersion
Patients allocated to hot water immersion will enter a bath and submerge down to the neck in warm water (40 degrees celsius) for 20 min.
干预措施: Thermotherapy (Other)
Control
Patients allocated to control group will sit down for a 20 min rest.
结局指标
主要结局
Concentrations of interleukin 6 (IL-6) in blood
时间窗: 8 weeks (aiming at 16 bath (or control) sessions during the intervention period
Change in IL-6 between groups after 8 weeks of intervention (aiming at 16 bath (or control) sessions during the intervention period)
次要结局
- Concentrations of biomarkers of metabolism in blood(8 weeks)
- Change in sympathetic/parasympathetic activity(8 weeks)
- Concentrations of other biomarkers of inflammation in blood(8 weeks)
- Change in percent in endothelial flow-mediated dilatation (FMD)(8 weeks)
- Change in diastolic and systolic blood pressure (mm(Hg)(8 weeks)
- Change in score of participants´ subjectively reported psychological well-being(8 weeks)