- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556422
Comparison of Acute Sauna With Exercise and Sauna
Standalone Sauna Versus Exercise Followed by Sauna on Cardiovascular Function in Non-naïve Sauna Users
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).
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Keski-Suomi
-
Jyväskylä, Keski-Suomi, Finland, 40014
- University of Jyväskylä
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sauna alone
Sauna exposure for 30 minutes
|
Passive heat exposure
|
Experimental: Exercise and Sauna
Cycling exercise for 15 minutes followed by sauna for 15 minutes
|
Passive heat exposure
15 minutes of aerobic exercise using stationary bicycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brachial blood pressure
Time Frame: Single session (30 minutes)
|
Systolic and diastolic blood pressure
|
Single session (30 minutes)
|
Central blood pressure
Time Frame: Single session (30 minutes)
|
Systolic and diastolic blood pressure measured using ECG and Pulsepen
|
Single session (30 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial Stiffness
Time Frame: Single session (30 minutes)
|
Pulsewave velocity (PWV)
|
Single session (30 minutes)
|
Augmentation Index
Time Frame: Single session (30 minutes)
|
Supplement to PWV
|
Single session (30 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jari A Laukkanen, PhD/MD, Central Finland Central Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Sauna
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blood Pressure
-
SE HealthCentre for Aging and Brain Health InnovationCompletedHypertension | Blood Pressure | Hypotension | High Blood Pressure | Low Blood PressureCanada
-
DongGuk UniversityActive, not recruitingHypertension | Blood Pressure | Ambulatory Blood Pressure | Home Blood Pressure MeasurementKorea, Republic of
-
ROX Medical, Inc.CompletedHypertension | Blood Pressure, High | Blood Pressure, Resistant | Blood Pressure, UncontrolledUnited Kingdom, Netherlands, Belgium
-
University of JordanCompletedBlood Pressure | Heart Rate | Airway PressureJordan
-
Istituto Auxologico ItalianoRecruitingArterial Hypertension | Ambulatory Blood Pressure Monitoring | Blood Pressure Determination | Home Blood Pressure MonitoringItaly
-
RadiRad Co., Ltd.Hualien Tzu Chi General HospitalNot yet recruitingBlood Pressure
-
Riphah International UniversityRecruiting
-
GE HealthcareNot yet recruiting
-
Guangdong Provincial People's HospitalRecruiting
-
Guangdong Provincial People's HospitalRecruiting
Clinical Trials on Sauna bathing
-
University of JyvaskylaCompletedSedentary Behavior | Cardiovascular Risk Factor | Heat StressFinland
-
University School of Physical Education, Krakow...University of BergenRecruiting
-
Maastricht University Medical CenterNetherlands Organisation for Scientific ResearchCompletedSarcopeniaNetherlands
-
Inonu UniversityCompletedNurse | Premature Newborn | Physiological MeasurementsTurkey
-
Maastricht University Medical CenterActive, not recruitingDiabetes Mellitus, Type 2Netherlands
-
Akdeniz UniversityCompletedPremature Birth | Preterm InfantTurkey
-
University of ArizonaCompletedPost-fire Rehabilitation of Firefighters in SaunaUnited States
-
Hospital for Special Surgery, New YorkNew York Presbyterian HospitalRecruitingSurgical Wound | Post Operative Wound InfectionUnited States
-
China Medical University HospitalCompleted
-
Akdeniz UniversityCompletedPremature | ThermoregulationTurkey