Cardiac Disease, Cardiac Rehabilitation
Conditions
Brief summary
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.
Interventions
OTHERThermotherapy
Hot baths directly after an exercise session
Sponsors
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of interleukin 6 (IL-6) in blood | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of biomarkers of metabolism in blood | 8 weeks | Heat shock factor (HSF)-1, High density lipoprotein, Low density lipoprotein, triglycerides, cholesterol, leptin and adiponectin, glucose, insulin |
| Change in percent in endothelial flow-mediated dilatation (FMD) | 8 weeks | Change after 8 weeks of intervention |
| Concentrations of other biomarkers of inflammation in blood | 8 weeks | Change in IL -1b, IL-10, tumor necrosis factor (TNF)-a, High sensitivity C-reactive protein, heat shock protein-72 after 8 weeks of intervention |
| Change in score of participants´ subjectively reported psychological well-being | 8 weeks | Measured with the Questionnaire Clinical Outcomes in Routine Evaluation (Core-GP), change after 8 weeks of intervention |
| Change in diastolic and systolic blood pressure (mm(Hg) | 8 weeks | Change after 8 weeks of intervention |
| Change in sympathetic/parasympathetic activity | 8 weeks | Change in heart rate variability after 8 weeks of intervention |
Countries
Sweden
Contacts
Primary ContactOle Fröbert, Professor
Backup ContactCecilia Bergh, PhD
Outcome results
None listed