Hot Water Immersion After Myocardial Infarction

NCT ID: NCT05725655

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hot water immersion

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.

Group Type: EXPERIMENTAL

Thermotherapy

Intervention Type: OTHER

Hot baths directly after an exercise session

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Thermotherapy

Hot baths directly after an exercise session

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Örebro University hospital

Örebro, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Ole Fröbert, Professor

Role: CONTACT

ole.frobert@regionorebrolan.se

+460196025413

Cecilia Bergh, PhD

Role: CONTACT

cecilia.bergh@regionorebrolan.se

Facility Contacts

Ole Fröbert, professor

Role: primary

ole.frobert@regionorebrolan.se

Cecilia Bergh, PhD

Role: backup

cecilia.bergh@oru.se

Other Identifiers

279938

Identifier Type: -

Identifier Source: org_study_id