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Hot Water Immersion After Myocardial Infarction

Study acronym: HOT-MI
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Dec 31, 2025 → Jul 30, 2027
See other at-risk trials from Region Örebro County

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Dec 31, 2025 to Jul 30, 2027
    • Enrollment closed, study ongoing
    • Site details revised
    v7
  2. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2025v6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 2024 to Dec 31, 2024
    • Study completion date: Nov 2025 to Dec 31, 2025
    • Start date changed from estimate of Nov 2023 to Oct 26, 2023
  5. Notable Start date: Apr 2023 to Nov 2023v3
  6. Notable Primary endpoint revised
    • Secondary endpoints: 5 to 6
    • Eligibility criteria expanded, about 3 words
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05725655
Lead Sponsor Region Örebro County
Conditions
(from sponsor)
Cardiac Disease, Cardiac Rehabilitation
Related terms Heart Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov