Cardiovascular Risk FactorNCT04556422
Comparison of Acute Sauna With Exercise and Sauna
A study testing Aerobic exercise and Sauna bathing in people with Cardiovascular Risk Factor and Blood Pressure, run by University of Jyvaskyla at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Cardiovascular Risk Factor, Blood Pressure, Arterial Stiffness
- What is being tested?
- Aerobic exercise and Sauna bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Aerobic exercise, Sauna bathing
- Keywords
- Sauna bathing, Aerobic exercise, Thermal therapy, Passive heat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
15 minutes of aerobic exercise using stationary bicycle
Sauna bathingOther
Passive heat exposure
| Study group | Role | What they receive |
|---|---|---|
| Sauna alone | Active comparator | Sauna exposure for 30 minutes Receives: Other: Sauna bathing |
| Exercise and Sauna | Experimental | Cycling exercise for 15 minutes followed by sauna for 15 minutes Receives: Other: Aerobic exercise; Other: Sauna bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial blood pressure
Systolic and diastolic blood pressure
Measured: Single session (30 minutes)
Central blood pressure
Systolic and diastolic blood pressure measured using ECG and Pulsepen
Measured: Single session (30 minutes)
Secondary outcomes (2)
Arterial Stiffness
Pulsewave velocity (PWV)
Measured: Single session (30 minutes)
Augmentation Index
Supplement to PWV
Measured: Single session (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Aug 2018
- Primary completion30 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Foundation for Cardiovascular Research, Business Finland, Harvia Finland Oy
- Responsible party
- Sponsor
- Investigators
- Jari A Laukkanen, PhD/MD, Principal investigator, Central Finland Hospital District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556422
- Sponsor's protocol ID
- Sauna
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29048215Laukkanen 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.
PubMed 29269746Lee 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.
PubMed 31177835
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standalone Sauna Versus Exercise Followed by Sauna on Cardiovascular Function in Non-naïve Sauna Users
- ClinicalTrials.gov ID
- NCT04556422
- Acronym / sponsor ID
- Sauna
- Keywords
- Sauna bathing, Aerobic exercise, Thermal therapy, Passive heat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- Finnish Foundation for Cardiovascular Research, Business Finland, Harvia Finland Oy
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sauna alone | Active comparator | Other: Sauna bathingSauna exposure for 30 minutes |
| Exercise and Sauna | Experimental | Other: Aerobic exercise, Other: Sauna bathingCycling exercise for 15 minutes followed by sauna for 15 minutes |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise15 minutes of aerobic exercise using stationary bicycle | Other | Exercise and Sauna |
| Sauna bathingPassive heat exposure | Other | Exercise and Sauna, Sauna alone |
Primary outcome
Brachial blood pressure
Time frame: Single session (30 minutes)
Systolic and diastolic blood pressure
Central blood pressure
Time frame: Single session (30 minutes)
Systolic and diastolic blood pressure measured using ECG and Pulsepen
2 secondary outcomes
Arterial Stiffness
Time frame: Single session (30 minutes)
Augmentation Index
Time frame: Single session (30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Background: PubMed 29048215Lee 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.
- Background: PubMed 29269746Laukkanen 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.
- Background: PubMed 31177835Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari A Laukkanen, PhD/MD principal investigator
Central Finland Hospital District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Sauna bathing in people with Cardiovascular Risk Factor and Blood Pressure, run by University of Jyvaskyla at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial blood pressure (time frame: Single session (30 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556422, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.