Clinical trial NCT04540718: Exercise and Sauna on Blood Pressure and Cardiovascular Health
Official title: The Effects of Using Sauna Exposure to Augment Regular Exercise on Vascular Health and Hemodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Heat Stress
Sedentary Behavior
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 47
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups of which; 1 serves as a control group, 1 exercise group, and 1 exercise and sauna group
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to investigate the effects of including regular heat therapy when included to exercise. Specifically, participants in the sauna intervention group will undergo 15 minutes of sauna exposure immediately after a 50-minute session of exercise, 3 times a week, while participants in the exercise intervention group will follow only the same exercise protocol.

The 50-minute exercise session consists of 20 minutes of moderate intensity strength exercise, followed by 30 minutes of moderate-vigorous aerobic exercise on stationary bikes. This exercise intervention protocol was selected in order to meet and adhere to the recommended physical activity guidelines.

Detailed description: The main purpose of the experiment is to investigate the cardiovascular modulations of sauna use with respect to vascular compliance and hemodynamics. The investigators seek to understand the long-term adaptations of regular sauna bathing in conjunction with exercise, particularly in sedentary populations with cardiovascular risk factors.

Of particular interests are the cardiovascular adaptations of regular sauna bathing when used in conjunction with exercise training; which meets the recommended minimum of current physical activity guidelines. Recent studies have shown that long-term sauna use with exercise is more effective than sauna use alone in patients with chronic heart failure. However several questions pertaining to regular exercise in combination with sauna use remain to be answered, as experimental data in the general population is still lacking.

This research project aims to find out the differences (if any) in cardiovascular and hemodynamic-related outcome parameters, between regular exercise according to the minimum recommended guidelines, and the same exercise program with an additional regular 15 minute sauna session post exercise.

The training intervention will last for 8 weeks, with each session consisting of 20 minutes of moderate intensity resistance training, followed by 30 minutes of aerobic training. Participants in the exercise only group rested in the training area for 15 minutes while the exercise and sauna participants went to the sauna for 15 minutes.

Temperature of the sauna room was increased by 5 degrees celsius every fortnight starting from 65 degrees celsius; during the final 2 weeks of the intervention the sauna temperature was at 80 degrees celsius. (65, 70, 75, 80). Participants were told that they could leave the sauna room anytime they felt uncomfortable or if they wish to.

Eligibility criteria: Inclusion Criteria:

* At least one conventional cardiovascular risk factor but asymptomatic for coronary heart disease or diabetes

Exclusion Criteria:

* Use of sauna more than once a week,
* Exercise more than 30 minutes a week,
* low blood pressure,
* any diagnosed and/or symptomatic cardiovascular disease,
* musculoskeletal injury,
* any other physical or mental condition that will prohibit the participation in the experiment,
* participation to any other study at the same time.

Primary outcomes:
measure: Hemodynamics
timeFrame: 8 weeks
measure: Cardiovascular fitness
timeFrame: 8 weeks
Secondary outcomes:
measure: Blood biomarker
timeFrame: 8 weeks
measure: Cardiac marker
timeFrame: 8 weeks
measure: Arterial stiffness
timeFrame: 8 weeks
measure: Body fat
timeFrame: 8 weeks
Other outcomes:
measure: Heart rate variability (HRV)
timeFrame: 8 weeks
measure: Haemoglobin concentration (endothelial function)
timeFrame: 8 weeks
measure: Blood flow (endothelial function)
timeFrame: 8 weeks
measure: Concentration of Nicotinamide Adenine Dinucleotide (NAD)
timeFrame: 8 weeks
Locations:
city: Jyväskylä
country: Finland
facility: University of Jyväskylä
state: Keski-Suomi
Study officials:
affiliation: University of Jyvaskyla
name: Jari A Laukkanen, PhD
role: PRINCIPAL_INVESTIGATOR
References: