Cardiovascular Risk FactorES2019NCT04540718
Exercise and Sauna on Blood Pressure and Cardiovascular Health
A study testing Exercise and Sauna in people with Cardiovascular Risk Factor and Heat Stress, run by University of Jyvaskyla at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Cardiovascular Risk Factor, Heat Stress, Sedentary Behavior
- What is being tested?
- Exercise and Sauna
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFinland
- Study dates
- 8 Aug 2019to 15 Dec 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- At least one conventional cardiovascular risk factor but asymptomatic for coronary heart disease or diabetes
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Using Sauna Exposure to Augment Regular Exercise on Vascular Health and Hemodynamics
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor, Heat Stress, Sedentary Behavior
- Being tested
- Exercise, Sauna
- Medical subject headings
- Heat Stress Disorders, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Exercise training
50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks.
SaunaOther
Also called Sauna bathing, Sauna exposure
15 minutes of sauna exposure immediately after exercise intervention, three times a week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this group continues with their sedentary behavior |
| Exercise only | Active comparator | 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. Receives: Other: Exercise |
| Exercise and sauna | Experimental | 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. Receives: Other: Exercise; Other: Sauna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics
Blood pressure (systolic and diastolic)
Measured: 8 weeks
Cardiovascular fitness
Estimated oxygen uptake
Measured: 8 weeks
Secondary outcomes (4)
Blood biomarker
Blood cholesterol (fasted)
Measured: 8 weeks
Cardiac marker
Augmentation Index
Measured: 8 weeks
Arterial stiffness
Pulse wave velocity
Measured: 8 weeks
Body fat
Fat mass in kilograms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start8 Aug 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups of which; 1 serves as a control group, 1 exercise group, and 1 exercise and sauna group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jari A Laukkanen, PhD, Principal investigator, University of Jyvaskyla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540718
- Sponsor's protocol ID
- UJyvaskyla
- Acronym
- ES2019
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2019
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Sauna Exposure to Augment Regular Exercise on Vascular Health and Hemodynamics
- ClinicalTrials.gov ID
- NCT04540718
- Acronym / sponsor ID
- ES2019 / UJyvaskyla
- Conditions
- Cardiovascular Risk Factor, Heat Stress, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 7 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups of which; 1 serves as a control group, 1 exercise group, and 1 exercise and sauna group
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this group continues with their sedentary behavior |
| Exercise only | Active comparator | Other: ExerciseParticipants 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. |
| Exercise and sauna | Experimental | Other: Exercise, Other: SaunaParticipants 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least one conventional cardiovascular risk factor but asymptomatic for coronary heart disease or diabetes
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| ExerciseAlso: Exercise training50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks. | Other | Exercise and sauna, Exercise only |
| SaunaAlso: Sauna bathing, Sauna exposure15 minutes of sauna exposure immediately after exercise intervention, three times a week for eight weeks. | Other | Exercise and sauna |
Primary outcome
Hemodynamics
Time frame: 8 weeks
Blood pressure (systolic and diastolic)
Cardiovascular fitness
Time frame: 8 weeks
Estimated oxygen uptake
4 secondary outcomes
Blood biomarker
Time frame: 8 weeks
Cardiac marker
Time frame: 8 weeks
Arterial stiffness
Time frame: 8 weeks
Body fat
Time frame: 8 weeks
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 6 Jan 2022.
- 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 principal investigator
University of Jyvaskyla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Sauna in people with Cardiovascular Risk Factor and Heat Stress, 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 7 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 6 Jan 2022. 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?
Hemodynamics (time frame: 8 weeks). 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?
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 6 Jan 2022.