NCT04540718

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

December 16, 2019

Last Update Submit

January 3, 2022

Conditions

Cardiovascular Risk FactorHeat StressSedentary Behavior

Outcome Measures

Primary Outcomes (2)

  • Hemodynamics

    Blood pressure (systolic and diastolic)

    8 weeks

  • Cardiovascular fitness

    Estimated oxygen uptake

    8 weeks

Secondary Outcomes (4)

  • Blood biomarker

    8 weeks

  • Cardiac marker

    8 weeks

  • Arterial stiffness

    8 weeks

  • Body fat

    8 weeks

Other Outcomes (4)

  • Heart rate variability (HRV)

    8 weeks

  • Haemoglobin concentration (endothelial function)

    8 weeks

  • Blood flow (endothelial function)

    8 weeks

  • +1 more other outcomes

Study Arms (3)

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.

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.

Other: ExerciseOther: Sauna

Interventions

ExerciseOTHER

50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks.

Also known as: Exercise training
Exercise and saunaExercise only
SaunaOTHER

15 minutes of sauna exposure immediately after exercise intervention, three times a week for eight weeks.

Also known as: Sauna bathing, Sauna exposure
Exercise and sauna

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • At least one conventional cardiovascular risk factor but asymptomatic for coronary heart disease or diabetes

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jyväskylä

Jyväskylä, Central Finland, 40014, Finland

Location

MeSH Terms

Conditions

Heat Stress DisordersSedentary Behavior

Interventions

ExerciseSteam Bath

Condition Hierarchy (Ancestors)

Wounds and InjuriesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaBalneologyTherapeuticsHyperthermia, Induced

Study Officials

  • Jari A Laukkanen, PhD

    University of Jyvaskyla

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data statisticians (2) are blind to participant allocation
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 3 groups of which; 1 serves as a control group, 1 exercise group, and 1 exercise and sauna group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2019

First Posted

September 7, 2020

Study Start

August 8, 2019

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

January 6, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)