- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540718
Exercise and Sauna on Blood Pressure and Cardiovascular Health (ES2019)
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.
Study Overview
Status
Intervention / Treatment
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 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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks.
Other Names:
|
|
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.
|
50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks.
Other Names:
15 minutes of sauna exposure immediately after exercise intervention, three times a week for eight weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodynamics
Time Frame: 8 weeks
|
Blood pressure (systolic and diastolic)
|
8 weeks
|
|
Cardiovascular fitness
Time Frame: 8 weeks
|
Estimated oxygen uptake
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood biomarker
Time Frame: 8 weeks
|
Blood cholesterol (fasted)
|
8 weeks
|
|
Cardiac marker
Time Frame: 8 weeks
|
Augmentation Index
|
8 weeks
|
|
Arterial stiffness
Time Frame: 8 weeks
|
Pulse wave velocity
|
8 weeks
|
|
Body fat
Time Frame: 8 weeks
|
Fat mass in kilograms
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability (HRV)
Time Frame: 8 weeks
|
Heart rate variability
|
8 weeks
|
|
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. |
8 weeks
|
|
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. |
8 weeks
|
|
Concentration of Nicotinamide Adenine Dinucleotide (NAD)
Time Frame: 8 weeks
|
Nicotinamide Adenine Dinucleotide as measured from blood samples.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jari A Laukkanen, PhD, University of Jyväskylä
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UJyvaskyla
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 Sedentary Behavior
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)RecruitingSedentary Behavior | Sedentary TimeUnited States
-
Stanford UniversityActive, not recruiting
-
University of California, San DiegoCompleted
-
Cairo UniversityRecruitingSedentary BehaviorsEgypt
-
Istanbul Aydın UniversityCompletedSedentary Lifestyle | Functional CapacityTurkey (Türkiye)
-
Gazi UniversityCompletedSedentary | Athlete | Core Muscle EnduranceTurkey (Türkiye)
-
China-Japan Friendship HospitalNot yet recruitingSedentary Lifestyle | Behavioral Intervention
-
Sezer TaştanCompletedSedentary Lifestyle | Cardiorespiratory FitnessTurkey (Türkiye)
-
Recep Tayyip Erdogan UniversityCompletedPhysical Inactivity | Sedentary BehaviorsTurkey (Türkiye)
-
Research on Healthcare Performance Lab U1290RecruitingSedentary Behavior | Sedentary Time | Health Behavior | Health-Related Behavior | Physical InactivityFrance
Clinical Trials on Exercise
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Aksaray University Training and Research HospitalCompletedExercise Training | Lactate Blood Increase | Cognitive Functions | BDNFTurkey (Türkiye)
-
University of Alabama at BirminghamCompletedCystic FibrosisUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting
-
University of Missouri-ColumbiaCompleted
-
University of AlcalaCompletedMyofascial Pain | Myofascial Pain Syndrome | Post Needling Soreness | Myofascial Trigger Point PainSpain
-
University College CorkRecruitingDepressive Disorder, MajorIreland
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of