HealthyNCT05894031
The Effectiveness of the Wim Hof Method
A study testing Wim Hof Method in people with Healthy and Blood Pressure, run by University of Bern at 1 site in Switzerland.
Trial summary
The Wim Hof Method is a multi-disciplinary approach to physical and mental well-being combining cold exposure, breathing exercises, and meditation. This study evaluated the effects of a 15-day WHM intervention on cardiovascular parameters at rest and during a cold pressor test, as well as on various psychological… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Blood Pressure, Cold Exposure
- What is being tested?
- Wim Hof Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being male
- No underlying health conditions
- Not using antihypertensive or other cardiovascular medications
- Not engaging in regular exercise training
- Written informed consent
Who cannot join
- Having prior experience with any of the components of the intervention (breathing, meditation, or cold exposure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Wim Hof Method on Cardiac Autonomic Function, Blood Pressure, Arterial Compliance, and Different Psychological Parameters
The Wim Hof Method is a multi-disciplinary approach to physical and mental well-being combining cold exposure, breathing exercises, and meditation. This study evaluated the effects of a 15-day WHM intervention on cardiovascular parameters at rest and during a cold pressor test, as well as on various psychological parameters.
Read the detailed description
The Wim Hof Method (WHM) is a multi-disciplinary approach to physical and mental well-being combining cold exposure, breathing exercises, and meditation. This study evaluated the effects of a 15-day WHM intervention on cardiovascular parameters at rest and during a cold pressor test (CPT), as well as on various psychological parameters.
42 participants were randomized into an intervention (IG) and a control (CG) group. Throughout the 15-day intervention, the IG performed the WHM daily. The intervention followed the guidelines provided by Wim Hof. The intervention comprised three components: cold water exposure, breathing exercise, and meditation. The participants were instructed to perform the WHM daily over the course of 15 days. The participants could choose when to do so throughout the day, however, the components were to be performed in a strict, sequential order: breathing exercises, followed by meditation, and then cold exposure. Participants were asked to complete a daily log in which they documented whether they performed the procedure and for how long. Altogether, the procedure lasted about 15 minutes. The CG did not receive an intervention throughout the intervention period.
Before and after the intervention, systolic (SBP) and diastolic blood pressure (DBP), pulse wave velocity (PWV), heart rate (HR), root mean sum of squared distance (RMSSD), and standard deviation of intervals between successive heartbeats (SDNN) were assessed at rest and during a CPT. Furthermore, perceived stress (PSS), positive affect (PANAS+), negative affect (PANAS-), and subjective vitality (trait (SVSt) and state (SVSs)) was determined.
- Conditions
- Healthy, Blood Pressure, Cold Exposure, Stress
- Being tested
- Wim Hof Method
- Keywords
- Blood pressure, Hemodynamics, Heart rate variability, Perceived stress, Meditation, Cold exposure, Breathing-method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wim Hof MethodBehavioural
The intervention followed the guidelines provided by Wim Hof. The intervention comprised three components: cold water exposure, breathing exercise, and meditation.The participants were instructed to perform the WHM daily over the course of 15 days. The participants could choose when to do so throughout the day, however, the components were to be performed in a strict, sequential order: breathing exercises, followed by meditation, and then cold exposure. Participants were asked to complete a daily log in which they documented whether they performed the procedure and for how long. Altogether, the procedure lasted about 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group was instructed to perform the Wim Hof Method daily over the course of 15 days. The participants could choose when to do so throughout the day, however, the components were to be performed in a strict, sequential order: breathing exercises, followed by meditation, and then cold exposure. Participants were asked to complete a daily log in which they documented whether they performed the procedure and for how long. Altogether, the procedure lasted about 15 minutes. Receives: Behavioral: Wim Hof Method |
| Control | No intervention | The control group received noch intervention throughout the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean systolic blood pressure
Participants were instructed to rest in a supine position for 10 minutes prior to the measurement. At least two readings were taken on the right upper arm, using custom-fitted arm cuffs.
Measured: 15 days
Change from baseline in the mean diastolic blood pressure
Participants were instructed to rest in a supine position for 10 minutes prior to the measurement. At least two readings were taken on the right upper arm, using custom-fitted arm cuffs.
Measured: 15 days
Secondary outcomes (5)
Change from baseline in the mean pulse wave velocity
Participants were instructed to rest in a supine position for 10 minutes prior to the measurement. At least two readings were taken on the right upper arm, using custom-fitted arm cuffs.
Measured: 15 days
Change from baseline in the mean heart rate variability
Heart rate variability (HRV) was measured using a heart rate monitor and chest strap. Participants were instructed to empty their bladder before the measurement, which was conducted after a 5-minute supine rest period with a stabilized HRV signal. The measurement consisted of a 5-minute recording of intervals between successive heartbeats at a 1000 Hz sampling rate. Participants were instructed to breathe normally, remain quiet, and maintain a calm state throughout the measurement.
Measured: 15 days
Change from baseline in positive affect
The German version of the Positive and Negative Affect Schedule was used.
Measured: 15 days
Change from baseline in negative affect
The German version of the Positive and Negative Affect Schedule was used.
Measured: 15 days
Change in subjective vitality
The German 6-item Version of the Subjective Vitality Scale was used.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 May 2022
- Primary completion30 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with parallel arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sascha Ketelhut, PhD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894031
- Sponsor's protocol ID
- 2022-04-00004
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All raw data are available on request to the corresponding author.
Publications
Ketelhut S, Benzing V, Zehnder C, Amor L, Schurch Y, Burger M, Schmid S, Nigg CR. Effects of exergaming versus endurance training on cardiorespiratory fitness and hemodynamic parameters: a randomized controlled trial. Eur J Appl Physiol. 2025 Jul;125(7):1817-1830. doi: 10.1007/s00421-025-05743-z. Epub 2025 Mar 11.
PubMed 40067458
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Wim Hof Method on Cardiac Autonomic Function, Blood Pressure, Arterial Compliance, and Different Psychological Parameters
- ClinicalTrials.gov ID
- NCT05894031
- Acronym / sponsor ID
- 2022-04-00004
- Conditions
- Healthy, Blood Pressure, Cold Exposure, Stress
- Keywords
- Blood pressure, Hemodynamics, Heart rate variability, Perceived stress, Meditation, Cold exposure, Breathing-method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Wim Hof Method is a multi-disciplinary approach to physical and mental well-being combining cold exposure, breathing exercises, and meditation. This study evaluated the effects of a 15-day WHM intervention on cardiovascular parameters at rest and during a cold pressor test, as well as on various psychological parameters.
Detailed description
The Wim Hof Method (WHM) is a multi-disciplinary approach to physical and mental well-being combining cold exposure, breathing exercises, and meditation. This study evaluated the effects of a 15-day WHM intervention on cardiovascular parameters at rest and during a cold pressor test (CPT), as well as on various psychological parameters.
42 participants were randomized into an intervention (IG) and a control (CG) group. Throughout the 15-day intervention, the IG performed the WHM daily. The intervention followed the guidelines provided by Wim Hof. The intervention comprised three components: cold water exposure, breathing exercise, and meditation. The participants were instructed to perform the WHM daily over the course of 15 days. The participants could choose when to do so throughout the day, however, the components were to be performed in a strict, sequential order: breathing exercises, followed by meditation, and then cold exposure. Participants were asked to complete a daily log in which they documented whether they performed the procedure and for how long. Altogether, the procedure lasted about 15 minutes. The CG did not receive an intervention throughout the intervention period.
Before and after the intervention, systolic (SBP) and diastolic blood pressure (DBP), pulse wave velocity (PWV), heart rate (HR), root mean sum of squared distance (RMSSD), and standard deviation of intervals between successive heartbeats (SDNN) were assessed at rest and during a CPT. Furthermore, perceived stress (PSS), positive affect (PANAS+), negative affect (PANAS-), and subjective vitality (trait (SVSt) and state (SVSs)) was determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with parallel arms
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Wim Hof MethodThe intervention group was instructed to perform the Wim Hof Method daily over the course of 15 days. The participants could choose when to do so throughout the day, however, the components were to be performed in a strict, sequential order: breathing exercises, followed by meditation, and then cold exposure. Participants were asked to complete a daily log in which they documented whether they performed the procedure and for how long. Altogether, the procedure lasted about 15 minutes. |
| Control | No intervention | –The control group received noch intervention throughout the intervention period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being male
- No underlying health conditions
- Not using antihypertensive or other cardiovascular medications
- Not engaging in regular exercise training
- Written informed consent
Key exclusion criteria (1 listed)
- Having prior experience with any of the components of the intervention (breathing, meditation, or cold exposure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wim Hof MethodThe intervention followed the guidelines provided by Wim Hof. The intervention comprised three components: cold water exposure, breathing exercise, and meditation.The participants were instructed to perform the WHM daily over the course of 15 days. The participants could choose when to do so throughout the day, however, the components were to be performed in a strict, sequential order: breathing exercises, followed by meditation, and then cold exposure. Participants were asked to complete a daily log in which they documented whether they performed the procedure and for how long. Altogether, the procedure lasted about 15 minutes. | Behavioural | Intervention |
Primary outcome
Change from baseline in the mean systolic blood pressure
Time frame: 15 days
Participants were instructed to rest in a supine position for 10 minutes prior to the measurement. At least two readings were taken on the right upper arm, using custom-fitted arm cuffs.
Change from baseline in the mean diastolic blood pressure
Time frame: 15 days
Participants were instructed to rest in a supine position for 10 minutes prior to the measurement. At least two readings were taken on the right upper arm, using custom-fitted arm cuffs.
5 secondary outcomes
Change from baseline in the mean pulse wave velocity
Time frame: 15 days
Change from baseline in the mean heart rate variability
Time frame: 15 days
Change from baseline in positive affect
Time frame: 15 days
Change from baseline in negative affect
Time frame: 15 days
Change in subjective vitality
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Derived from this study: PubMed 40067458Ketelhut S, Benzing V, Zehnder C, Amor L, Schurch Y, Burger M, Schmid S, Nigg CR. Effects of exergaming versus endurance training on cardiorespiratory fitness and hemodynamic parameters: a randomized controlled trial. Eur J Appl Physiol. 2025 Jul;125(7):1817-1830. doi: 10.1007/s00421-025-05743-z. Epub 2025 Mar 11.
- Individual participant dataSharing planned: Yes. All raw data are available on request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascha Ketelhut, PhD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wim Hof Method in people with Healthy and Blood Pressure, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the mean systolic blood pressure (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.