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Exercise and Sauna on Blood Pressure and Cardiovascular Health (ES2019)

Primary Purpose

Cardiovascular Risk Factor, Heat Stress, Sedentary Behavior

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exercise
Sauna
Sponsored by
University of Jyvaskyla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Risk Factor

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Jyväskylä

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Exercise only

Exercise and sauna

Arm Description

Participants in this group continues with their sedentary behavior

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.

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.

Outcomes

Primary Outcome Measures

Hemodynamics
Blood pressure (systolic and diastolic)
Cardiovascular fitness
Estimated oxygen uptake

Secondary Outcome Measures

Blood biomarker
Blood cholesterol (fasted)
Cardiac marker
Augmentation Index
Arterial stiffness
Pulse wave velocity
Body fat
Fat mass in kilograms

Full Information

First Posted
December 16, 2019
Last Updated
January 3, 2022
Sponsor
University of Jyvaskyla
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1. Study Identification

Unique Protocol Identification Number
NCT04540718
Brief Title
Exercise and Sauna on Blood Pressure and Cardiovascular Health
Acronym
ES2019
Official Title
The Effects of Using Sauna Exposure to Augment Regular Exercise on Vascular Health and Hemodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Jyvaskyla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Heat Stress, Sedentary Behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 groups of which; 1 serves as a control group, 1 exercise group, and 1 exercise and sauna group
Masking
Outcomes Assessor
Masking Description
Data statisticians (2) are blind to participant allocation
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group continues with their sedentary behavior
Arm Title
Exercise only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise and sauna
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Exercise training
Intervention Description
50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks.
Intervention Type
Other
Intervention Name(s)
Sauna
Other Intervention Name(s)
Sauna bathing, Sauna exposure
Intervention Description
15 minutes of sauna exposure immediately after exercise intervention, three times a week for eight weeks.
Primary Outcome Measure Information:
Title
Hemodynamics
Description
Blood pressure (systolic and diastolic)
Time Frame
8 weeks
Title
Cardiovascular fitness
Description
Estimated oxygen uptake
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Blood biomarker
Description
Blood cholesterol (fasted)
Time Frame
8 weeks
Title
Cardiac marker
Description
Augmentation Index
Time Frame
8 weeks
Title
Arterial stiffness
Description
Pulse wave velocity
Time Frame
8 weeks
Title
Body fat
Description
Fat mass in kilograms
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Heart rate variability (HRV)
Description
Heart rate variability
Time Frame
8 weeks
Title
Haemoglobin concentration (endothelial function)
Description
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.
Time Frame
8 weeks
Title
Blood flow (endothelial function)
Description
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.
Time Frame
8 weeks
Title
Concentration of Nicotinamide Adenine Dinucleotide (NAD)
Description
Nicotinamide Adenine Dinucleotide as measured from blood samples.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jari A Laukkanen, PhD
Organizational Affiliation
University of Jyvaskyla
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jyväskylä
City
Jyväskylä
State/Province
Keski-Suomi
ZIP/Postal Code
40014
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise and Sauna on Blood Pressure and Cardiovascular Health

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