Hot Water Immersion After Myocardial Infarction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Örebro County

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thermotherapy

    Other intervention

    Hot baths directly after an exercise session

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Hot water immersionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Concentrations of interleukin 6 (IL-6) in blood

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 (aiming at 16 bath (or control) sessions during the intervention period

Secondary outcomes

1

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

Time frame
8 weeks
2

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

Time frame
8 weeks
3

Change in percent in endothelial flow-mediated dilatation (FMD)

Change after 8 weeks of intervention

Time frame
8 weeks
4

Change in sympathetic/parasympathetic activity

Change in heart rate variability after 8 weeks of intervention

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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