Exercise and Sauna on Blood Pressure and Cardiovascular Health (ES2019)

• ClinicalTrials.gov Identifier: NCT04540718
• Recruitment Status: Completed
• First Posted: September 7, 2020
• Last Update Posted: January 6, 2022
• Sponsor: University of Jyvaskyla
• Information provided by (Responsible Party): University of Jyvaskyla

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Risk Factor; Heat Stress; Sedentary Behavior	Other: Exercise; Other: Sauna	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 3 groups of which; 1 serves as a control group, 1 exercise group, and 1 exercise and sauna group
• Masking: Single (Outcomes Assessor)
• Masking Description: Data statisticians (2) are blind to participant allocation
• Primary Purpose: Basic Science
• Official Title: The Effects of Using Sauna Exposure to Augment Regular Exercise on Vascular Health and Hemodynamics
• Actual Study Start Date: August 8, 2019
• Actual Primary Completion Date: December 15, 2019
• Actual Study Completion Date: December 15, 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; Participants in this group continues with their sedentary behavior
Active Comparator: Exercise only; Participants in this group performs exercise 3 times a week (150 minutes total) according to the recommended exercise guidelines and will sit in the exercise laboratory for 15 minutes whilst the experimental group uses the sauna.	Other: Exercise; 50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks.; Other Name: Exercise training
Experimental: Exercise and sauna; Participants in this group performs exercise 3 times a week (150 minutes total) according to the recommended exercise guidelines and incorporates sauna bathing (heat therapy) immediately after exercise.	Other: Exercise; 50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks.; Other Name: Exercise training; Other: Sauna; 15 minutes of sauna exposure immediately after exercise intervention, three times a week for eight weeks.; Other Names: Sauna bathing; Sauna exposure

Outcome Measures

Primary Outcome Measures :

1. Hemodynamics [ Time Frame: 8 weeks ]
   Blood pressure (systolic and diastolic)
2. Cardiovascular fitness [ Time Frame: 8 weeks ]
   Estimated oxygen uptake

Secondary Outcome Measures :

1. Blood biomarker [ Time Frame: 8 weeks ]
   Blood cholesterol (fasted)
2. Cardiac marker [ Time Frame: 8 weeks ]
   Augmentation Index
3. Arterial stiffness [ Time Frame: 8 weeks ]
   Pulse wave velocity
4. Body fat [ Time Frame: 8 weeks ]
   Fat mass in kilograms

Other Outcome Measures:

1. Heart rate variability (HRV) [ Time Frame: 8 weeks ]
   Heart rate variability
2. Haemoglobin concentration (endothelial function) [ Time Frame: 8 weeks ]

   Moor instrument (moorVMS) near infrared spectroscopy (NIRS) will be used with a post occlusive reactive hyperaemia (PORH) protocol to assess haemoglobin concentration.

   The moorVMS-NIRS uses the established spatially resolved spectroscopy technique to measure absolute concentrations of oxygenated haemoglobin in human tissue. The system measures oxygenation using a probe which is placed in contact with the skin. Each probe consists of a detector head which contains two identical photodiodes and an emitter head which contains two near infrared light emitting diodes (LED) emitting light at approximately 750nm and 850nm. Light from the emitter head enters the tissue where it is subject to scattering and absorption. A small proportion of the incident light passes through the tissue to the photodiodes. The resulting photocurrents are amplified and acquired by the instrument.

3. Blood flow (endothelial function) [ Time Frame: 8 weeks ]

   Moor instrument (moorVMS) laser doppler flowmetry (LDF) will be used with a post occlusive reactive hyperaemia (PORH) protocol to assess bloodflow (flux).

   The moorVMS-LDF uses the laser doppler technique where a low power laser light is transmitted via an optic fibre to the tissue. The light is scattered by tissue and moving blood cells and its frequency is Doppler broadened. Some of the scattered light is collected by one or more optic fibres and transmitted to a photo detector. The resulting photo current is electronically processed to produce the laser Doppler flux (blood flow) signal. The average Doppler frequency shift is directly proportional to the average speed of the blood cells.

4. Concentration of Nicotinamide Adenine Dinucleotide (NAD) [ Time Frame: 8 weeks ]
   Nicotinamide Adenine Dinucleotide as measured from blood samples.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Finland

University of Jyväskylä

Jyväskylä, Keski-Suomi, Finland, 40014

Sponsors and Collaborators

University of Jyvaskyla

Investigators

• Principal Investigator: Jari A Laukkanen, PhD; University of Jyvaskyla

More Information

• Responsible Party: University of Jyvaskyla
• ClinicalTrials.gov Identifier: NCT04540718
• Other Study ID Numbers: UJyvaskyla
• First Posted: September 7, 2020
• Last Update Posted: January 6, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Heat Stress Disorders; Wounds and Injuries