Hot Water Immersion After Myocardial Infarction

Cardiac Disease Clinical Trial

— HOT-MI  

Official title:

Hot Water Immersion in Rehabilitation After Myocardial Infarction (HOT-MI) - a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725655
• Other study ID #: 279938
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Region Örebro County
• Contact: Ole Fröbert, Professor
• Phone: +460196025413
• Email: ole.frobert[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Rehabilitation
• Heart Diseases
• Infarction
• Myocardial Infarction

Intervention

Other:
• Thermotherapy
Hot baths directly after an exercise session

Locations

Country	Name	City	State
Sweden	Örebro University hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of interleukin 6 (IL-6) in blood	Change in IL-6 between groups after 8 weeks of intervention	8 weeks
Secondary	Concentrations of other biomarkers of inflammation in blood	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	8 weeks
Secondary	Concentrations of biomarkers of metabolism in blood	Heat shock factor (HSF)-1, High density lipoprotein, Low density lipoprotein, triglycerides, cholesterol, leptin and adiponectin, glucose, insulin	8 weeks
Secondary	Change in percent in endothelial flow-mediated dilatation (FMD)	Change after 8 weeks of intervention	8 weeks
Secondary	Change in sympathetic/parasympathetic activity	Change in heart rate variability after 8 weeks of intervention	8 weeks
Secondary	Change in score of participants´ subjectively reported psychological well-being	Measured with the Questionnaire Clinical Outcomes in Routine Evaluation (Core-GP), change after 8 weeks of intervention	8 weeks
Secondary	Change in diastolic and systolic blood pressure (mm(Hg)	Change after 8 weeks of intervention	8 weeks