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NCT Number: NCT05725655

Hot Water Immersion After Myocardial Infarction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University hospital

Örebro, Sweden

Location status: Recruiting

Location contact

Cecilia Bergh, PhD

CONTACT

[email protected]

Ole Fröbert, professor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thermotherapy

Other

Hot baths directly after an exercise session

Primary outcomes

  1. Concentrations of interleukin 6 (IL-6) in blood

    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)

Secondary outcomes

  1. Concentrations of other biomarkers of inflammation in blood

    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

  2. Concentrations of biomarkers of metabolism in blood

    Time frame: 8 weeks

    Heat shock factor (HSF)-1, High density lipoprotein, Low density lipoprotein, triglycerides, cholesterol, leptin and adiponectin, glucose, insulin

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

    Time frame: 8 weeks

    Change after 8 weeks of intervention

  4. Change in sympathetic/parasympathetic activity

    Time frame: 8 weeks

    Change in heart rate variability after 8 weeks of intervention

  5. Change in score of participants´ subjectively reported psychological well-being

    Time frame: 8 weeks

    Measured with the Questionnaire Clinical Outcomes in Routine Evaluation (Core-GP), change after 8 weeks of intervention

  6. Change in diastolic and systolic blood pressure (mm(Hg)

    Time frame: 8 weeks

    Change after 8 weeks of intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia Bergh, PhD

CONTACT

[email protected]

Ole Fröbert, Professor

CONTACT

[email protected]

+460196025413

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

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

Acronym: HOT-MI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2023
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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