Örebro University hospital
Örebro, Sweden
Location status: Recruiting
NCT Number: NCT05725655
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Örebro, Sweden
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hot baths directly after an exercise session
Time frame: 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)
Time frame: 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
Time frame: 8 weeks
Heat shock factor (HSF)-1, High density lipoprotein, Low density lipoprotein, triglycerides, cholesterol, leptin and adiponectin, glucose, insulin
Time frame: 8 weeks
Change after 8 weeks of intervention
Time frame: 8 weeks
Change in heart rate variability after 8 weeks of intervention
Time frame: 8 weeks
Measured with the Questionnaire Clinical Outcomes in Routine Evaluation (Core-GP), change after 8 weeks of intervention
Time frame: 8 weeks
Change after 8 weeks of intervention
Contact information is provided by the study sponsor or research team.
Cecilia Bergh, PhD
CONTACT
Ole Fröbert, Professor
CONTACT
Region Örebro County
Other
Hot Water Immersion in Rehabilitation After Myocardial Infarction (HOT-MI) - a Randomized Controlled Study
Acronym: HOT-MI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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