- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875466
Exploring the Health Benefits of Sauna Bathing
Exploring the Health Benefits of Sauna Bathing - a Pilot Study
Study Overview
Detailed Description
Cardiovascular disease (CVD) remains the leading cause of mortality and morbidity in Aotearoa New Zealand. High blood pressure is a significant risk factor for CVD, with nearly half of older adults in Aotearoa diagnosed with hypertension, and it being relatively intractable to attempts thus far at treatment via antihypertensive medications.
Finnish sauna bathing (FSB) is one form of heat therapy, characterised by the use of a wood-fired sauna in which water is thrown over hot stones to create steam. In Finland, the sauna is not only a common therapy but also deeply ingrained in the cultural fabric, with many households having their own sauna. Traditionally, saunas were communal places where people came together to relax and share experiences thus fostering social connections. Lifelong sauna use is associated with markedly lower risk for chronic diseases such as; CVD, stroke, and all-cause mortality. Integral to the FSB experience is the practice of cold water immersion (CWI) which typically involves a plunge into icy waters, or exposure to freezing temperatures, in between sauna bathing.
Sauna bathing is typically researched with a physiological / biomedical lens and in isolation, that is, the additive effects of sauna bathing and cold-induced adaptations from cold-water immersion are not well understood, highlighting a gap in this research area. Additionally, the health benefits of sauna are wide ranging, therefore our focus is to use a holistic lens to explore the impact of sauna bathing cardiovascular health.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tasha Burton, MSc
- Phone Number: 0220180557
- Email: tasha@thecentreforhealth.co.nz
Study Contact Backup
- Name: Anna Rolleston, PhD
- Email: anna@thecentreforhealth.co.nz
Study Locations
-
-
-
Tauranga, New Zealand, 3110
- Recruiting
- The Centre for Health
-
Contact:
- Anna Rolleston, PhD
- Email: anna@thecentreforhealth.co.nz
-
Contact:
- Tasha Burton, MSc
- Email: tasha@thecentreforhealth.co.nz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- SBP: 110-179 mmHg; DBP 60-99 mmHg)
- 18 - 70 y old.
- Participants who are prescribed anti-hypertensive or dyslipidaemia medications will be included but must be on a stable dose for at least 30 days.
Exclusion Criteria:
- stable or unstable angina
- recent myocardial infarction (<3 months)
- orthostatic hypotension
- severe aortic stenosis
- pregnancy
- acute infectious diseases
- rheumatoid arthritis in the acute inflammatory phase
- fever for any reason
- any other medical condition deemed a risk.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sauna Bathing
Participants receive the sauna bathing treatment (1 session per week for 8 weeks)
|
Finnish sauna bathing, participants will sauna once per week for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24 hour ambulatory blood pressure
Time Frame: 8 weeks
|
This measure will be taken before and after the intervention.
There are four sections of the questionnaire.
The first two sections use the scale 1 - 5 where 1 = never, 2 = rarely, 3 = occasionally, 4 = regularly, 5 = constantly.
A higher score means a worse outcome.
Section three uses the scale 1 - 5 where 1 = not at all, 2 = not really, 3 = sometimes, 4 = yes, 5 = yes, absolutely; in this section a higher score means a better outcome.
Section four uses a scale 1 - 5 where 1 = strongly disagree, 2 = disagree, 3 = not sure, 4 = agree, 5 = strongly agree; a higher score means a better outcome.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life questionnaire
Time Frame: 8 weeks
|
This measure will be taken before and after the intervention
|
8 weeks
|
|
PROMIS Sleep Questionnaire
Time Frame: 8 weeks
|
This measure will be taken before and after the intervention.
There are four questions which uses the scale is from 1 -5. 1 = Not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much.
There are three questions that use the scale 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
One questions uses the scale 1 = very poor, 2 = poor, 3 = fair, 4 = good, 5 = very good.
In all questions the higher score means a better outcome.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Rolleston, PhD, The Centre for Health
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- Sauna
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
product manufactured in and exported from the U.S.
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.
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