Hot Water Immersion After Myocardial Infarction

NCT05725655 | Recruiting

• 1 other identifier: 279938
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Concentrations of interleukin 6 (IL-6) in blood

  Change in IL-6 between groups after 8 weeks of intervention (aiming at 16 bath (or control) sessions during the intervention period)

  8 weeks (aiming at 16 bath (or control) sessions during the intervention period

Secondary Outcomes (6)

• Concentrations of other biomarkers of inflammation in blood

  8 weeks

• Concentrations of biomarkers of metabolism in blood

  8 weeks

• Change in percent in endothelial flow-mediated dilatation (FMD)

  8 weeks

• Change in sympathetic/parasympathetic activity

  8 weeks

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

  8 weeks

Study Arms (2)

Hot water immersion

EXPERIMENTAL

Patients allocated to hot water immersion will enter a bath and submerge down to the neck in warm water (40 degrees celsius) for 20 min.

Other: Thermotherapy

Control

NO INTERVENTION

Patients allocated to control group will sit down for a 20 min rest.

Interventions

Thermotherapy OTHER

Hot baths directly after an exercise session

Hot water immersion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro University hospital

Örebro, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Interventions

Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Ole Fröbert, Professor

CONTACT

+460196025413; ole.frobert@regionorebrolan.se

Cecilia Bergh, PhD

CONTACT

cecilia.bergh@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: October 26, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)