Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04556422
Other study ID # Sauna
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date December 1, 2018

Study information

Verified date September 2020
Source University of Jyvaskyla
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sauna bathing has been associated with a lower risk for cardiovascular disease (CVD) outcomes, improved vascular endothelial and cardiac function, reduced oxidative stress and lower blood pressure. Earlier studies conducted by the investigators have showed positive alterations of arterial stiffness and hemodynamics through sauna bathing.

Some studies have sought to utilize sauna bathing as an intervention after exercise with promising and synergistic results, although the effects on populations with cardiovascular risk factors are less clear. Furthermore, studies investigating the use of both exercise and sauna bathing in combination has been somewhat limited. However, results from some studies speculate that adjunctive exercise and sauna interventions may be useful for aging and clinical patient population groups.

Given that heat therapy and sauna use is gaining more worldwide popularity, the investigators sought to compare the acute hemodynamic effects between sauna use alone and a short bout of exercise followed by sauna exposure. It was hypothesize that the combination of exercise and sauna will elicit greater changes than sauna alone. To achieve this, we standardized the protocol duration (30 minutes).


Description:

In this crossover trial, all study participants underwent two interventions, each on a separate occasion (>72 hours apart). A standalone 30-minute sauna at 75°C (S), and 15-minutes of cycling on the stationary bike at 75% maximum heart rate, followed by 15-minutes of sauna exposure (ES). A cycling exercise test was conducted on a separate day prior to the experiment to ascertain individual maximal exercise heart rates, which was then used to calculate individual 75% maximum.

After the first 15-minute period of S, the participants left the sauna room to have a quick shower (<30 seconds) before going back for the second 15-minute period. The same sauna bathing room (75°C) was used for all participants and the cycling exercise was conducted within 10 meters of the sauna room to minimize transit time during ES. Participants were instructed to abstain from eating 2h, caffeine 12h and alcohol 24h prior to the measurements. Food intake was not standardized. Fluid was consumed ad libitum. A medical physician was in attendance at all times and participants were allowed to leave the sauna or stop the experiment at any time if they felt uncomfortable.

Brachial blood pressures and pulse wave velocity (PWV) as a measure of arterial stiffness, were taken in their respective order at three different time points; before (PRE), immediately after (POST), and after a 30-minute recovery (POST30). Transit time from the cessation of the intervention to POST measurements were kept under 60 seconds. All measurements were performed by the same assessor to minimize ascertainment biases.

Participants were permitted to take a quick shower (<30 seconds) before POST measurements were taken. Water temperature or the shower was not controlled and participants could freely select their desired temperature. Thereafter, they were instructed to rest in a designated waiting lounge (mean temperature 21°C) in a seated position for a duration of 30-minutes before the last measurement (POST30) was taken.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 1, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria:

- Free of a prior diagnosis of CVD, exhibits at least one of the following cardiovascular risk factors: a history of smoking, hyperlipidemia, hypertension, diabetes, obesity, or family history of coronary heart disease (CHD).

Exclusion Criteria:

- recent musculoskeletal injuries or surgery (less than 6 months ago), mental illnesses, under 30 years of age or over 75 at time of recruitment, health conditions that may contraindicate study parameters.

Study Design


Intervention

Other:
Aerobic exercise
15 minutes of aerobic exercise using stationary bicycle
Sauna bathing
Passive heat exposure

Locations

Country Name City State
Finland University of Jyväskylä Jyväskylä Keski-Suomi

Sponsors (4)

Lead Sponsor Collaborator
University of Jyvaskyla Business Finland, Finnish Foundation for Cardiovascular Research, Harvia Finland Oy

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Laukkanen T, Kunutsor SK, Zaccardi F, Lee E, Willeit P, Khan H, Laukkanen JA. Acute effects of sauna bathing on cardiovascular function. J Hum Hypertens. 2018 Feb;32(2):129-138. doi: 10.1038/s41371-017-0008-z. Epub 2017 Dec 21. — View Citation

Lee E, Laukkanen T, Kunutsor SK, Khan H, Willeit P, Zaccardi F, Laukkanen JA. Sauna exposure leads to improved arterial compliance: Findings from a non-randomised experimental study. Eur J Prev Cardiol. 2018 Jan;25(2):130-138. doi: 10.1177/2047487317737629. Epub 2017 Oct 19. — View Citation

Lee E, Willeit P, Laukkanen T, Kunutsor SK, Zaccardi F, Khan H, Laukkanen JA. Acute effects of exercise and sauna as a single intervention on arterial compliance. Eur J Prev Cardiol. 2020 Jul;27(10):1104-1107. doi: 10.1177/2047487319855454. Epub 2019 Jun 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Brachial blood pressure Systolic and diastolic blood pressure Single session (30 minutes)
Primary Central blood pressure Systolic and diastolic blood pressure measured using ECG and Pulsepen Single session (30 minutes)
Secondary Arterial Stiffness Pulsewave velocity (PWV) Single session (30 minutes)
Secondary Augmentation Index Supplement to PWV Single session (30 minutes)
See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Recruiting NCT05997303 - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT03918486 - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed NCT03410342 - The Effects of Types of Fruits and Vegetables on Vascular Function N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT03294928 - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03997461 - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device N/A
Completed NCT03290716 - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China N/A
Recruiting NCT05196048 - Blood Pressure Sensor of Watch-type Device With ECG Technology
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Completed NCT02924454 - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol. Phase 4
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Active, not recruiting NCT02670967 - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials N/A
Completed NCT02271633 - Nitrate Supplementation; Source Phase 4
Completed NCT02239744 - Intervention Study on the Health Impact of Air Filters in Chinese Adults N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Withdrawn NCT01026961 - Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers Phase 1/Phase 2