Clinical trial NCT05725655: Hot Water Immersion After Myocardial Infarction
Official title: Hot Water Immersion in Rehabilitation After Myocardial Infarction (HOT-MI) - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Cardiac Rehabilitation
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentrations of interleukin 6 (IL-6) in blood
timeFrame: 8 weeks (aiming at 16 bath (or control) sessions during the intervention period
Secondary outcomes:
measure: Concentrations of other biomarkers of inflammation in blood
timeFrame: 8 weeks
measure: Concentrations of biomarkers of metabolism in blood
timeFrame: 8 weeks
measure: Change in percent in endothelial flow-mediated dilatation (FMD)
timeFrame: 8 weeks
measure: Change in sympathetic/parasympathetic activity
timeFrame: 8 weeks
measure: Change in score of participants´ subjectively reported psychological well-being
timeFrame: 8 weeks
measure: Change in diastolic and systolic blood pressure (mm(Hg)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University hospital
Study officials:
References: