Hot Water Immersion After Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thermotherapy.
- Who it may be relevant to
- Registry conditions: Cardiac Disease, Cardiac Rehabilitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hot Water Immersion in Rehabilitation After Myocardial Infarction (HOT-MI) - a Randomized Controlled Study
Overview
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.
Interventions
- Other Thermotherapy
Hot baths directly after an exercise session
Primary outcome measures
- Concentrations of interleukin 6 (IL-6) in blood [Time frame: 8 weeks (aiming at 16 bath (or control) sessions during the intervention period]
Secondary outcome measures (6)
- Concentrations of other biomarkers of inflammation in blood [Time frame: 8 weeks]
- Concentrations of biomarkers of metabolism in blood [Time frame: 8 weeks]
- Change in percent in endothelial flow-mediated dilatation (FMD) [Time frame: 8 weeks]
- Change in sympathetic/parasympathetic activity [Time frame: 8 weeks]
- Change in score of participants´ subjectively reported psychological well-being [Time frame: 8 weeks]
- Change in diastolic and systolic blood pressure (mm(Hg) [Time frame: 8 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Örebro University hospital — Örebro
Identifiers
NCT: NCT05725655 · 279938