NCT04556422

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

September 14, 2020

Last Update Submit

September 21, 2020

Conditions

Keywords

Sauna bathingAerobic exerciseThermal therapyPassive heat

Outcome Measures

Primary Outcomes (2)

  • Brachial blood pressure

    Systolic and diastolic blood pressure

    Single session (30 minutes)

  • Central blood pressure

    Systolic and diastolic blood pressure measured using ECG and Pulsepen

    Single session (30 minutes)

Secondary Outcomes (2)

  • Arterial Stiffness

    Single session (30 minutes)

  • Augmentation Index

    Single session (30 minutes)

Study Arms (2)

Sauna alone

ACTIVE COMPARATOR

Sauna exposure for 30 minutes

Other: Sauna bathing

Exercise and Sauna

EXPERIMENTAL

Cycling exercise for 15 minutes followed by sauna for 15 minutes

Other: Aerobic exerciseOther: Sauna bathing

Interventions

15 minutes of aerobic exercise using stationary bicycle

Exercise and Sauna

Passive heat exposure

Exercise and SaunaSauna alone

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jyväskylä

Jyväskylä, Central Finland, 40014, Finland

Location

Related Publications (3)

  • 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.

    PMID: 29048215BACKGROUND
  • 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.

    PMID: 29269746BACKGROUND
  • 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.

    PMID: 31177835BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jari A Laukkanen, PhD/MD

    Central Finland Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 21, 2020

Study Start

August 1, 2018

Primary Completion

October 30, 2018

Study Completion

December 1, 2018

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations