NCT05725655 Hot Water Immersion After Myocardial Infarction
| NCT ID | NCT05725655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Örebro County |
| Condition | Cardiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-10-26 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-10-26 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05725655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05725655 currently recruiting?
Yes, NCT05725655 is actively recruiting participants. Contact the research team at ole.frobert@regionorebrolan.se for enrollment information.
Where is the NCT05725655 trial being conducted?
This trial is being conducted at Örebro, Sweden.
Who is sponsoring the NCT05725655 clinical trial?
NCT05725655 is sponsored by Region Örebro County. The trial plans to enroll 30 participants.