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Hot Water Immersion After Myocardial Infarction (HOT-MI)

Primary Purpose

Cardiac Disease, Cardiac Rehabilitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermotherapy
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hot water immersion

    Control

    Arm Description

    Patients allocated to hot water immersion will enter a bath and submerge down to the neck in warm water (40 degrees celsius) for 15 min.

    Patients allocated to control group will sit down for a 15 min rest.

    Outcomes

    Primary Outcome Measures

    Concentrations of interleukin 6 (IL-6) in blood
    Change in IL-6 between groups after 8 weeks of intervention

    Secondary Outcome Measures

    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
    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
    Change in percent in endothelial flow-mediated dilatation (FMD)
    Change after 8 weeks of intervention
    Change in sympathetic/parasympathetic activity
    Change in heart rate variability after 8 weeks of intervention
    Change in score of participants´ subjectively reported psychological well-being
    Measured with the Questionnaire Clinical Outcomes in Routine Evaluation (Core-GP), change after 8 weeks of intervention
    Change in diastolic and systolic blood pressure (mm(Hg)
    Change after 8 weeks of intervention

    Full Information

    First Posted
    February 2, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Region Örebro County
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05725655
    Brief Title
    Hot Water Immersion After Myocardial Infarction
    Acronym
    HOT-MI
    Official Title
    Hot Water Immersion in Rehabilitation After Myocardial Infarction (HOT-MI) - a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Örebro County

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Disease, Cardiac Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hot water immersion
    Arm Type
    Experimental
    Arm Description
    Patients allocated to hot water immersion will enter a bath and submerge down to the neck in warm water (40 degrees celsius) for 15 min.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients allocated to control group will sit down for a 15 min rest.
    Intervention Type
    Other
    Intervention Name(s)
    Thermotherapy
    Intervention Description
    Hot baths directly after an exercise session
    Primary Outcome Measure Information:
    Title
    Concentrations of interleukin 6 (IL-6) in blood
    Description
    Change in IL-6 between groups after 8 weeks of intervention
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Concentrations of other biomarkers of inflammation in blood
    Description
    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
    Title
    Concentrations of biomarkers of metabolism in blood
    Description
    Heat shock factor (HSF)-1, High density lipoprotein, Low density lipoprotein, triglycerides, cholesterol, leptin and adiponectin, glucose, insulin
    Time Frame
    8 weeks
    Title
    Change in percent in endothelial flow-mediated dilatation (FMD)
    Description
    Change after 8 weeks of intervention
    Time Frame
    8 weeks
    Title
    Change in sympathetic/parasympathetic activity
    Description
    Change in heart rate variability after 8 weeks of intervention
    Time Frame
    8 weeks
    Title
    Change in score of participants´ subjectively reported psychological well-being
    Description
    Measured with the Questionnaire Clinical Outcomes in Routine Evaluation (Core-GP), change after 8 weeks of intervention
    Time Frame
    8 weeks
    Title
    Change in diastolic and systolic blood pressure (mm(Hg)
    Description
    Change after 8 weeks of intervention
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ole Fröbert, Professor
    Phone
    +460196025413
    Email
    ole.frobert@regionorebrolan.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cecilia Bergh, PhD
    Email
    cecilia.bergh@regionorebrolan.se

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hot Water Immersion After Myocardial Infarction

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