NCT05894031

Brief 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 parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2022

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

May 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
Last Updated

June 8, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 30, 2023

Last Update Submit

May 30, 2023

Conditions

HealthyBlood PressureCold ExposureStress

Keywords

Blood pressureHemodynamicsHeart rate variabilityPerceived stressMeditationCold exposureBreathing-method

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    15 days

Secondary Outcomes (5)

  • Change from baseline in the mean pulse wave velocity

    15 days

  • Change from baseline in the mean heart rate variability

    15 days

  • Change from baseline in positive affect

    15 days

  • Change from baseline in negative affect

    15 days

  • Change in subjective vitality

    15 days

Study Arms (2)

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.

Behavioral: Wim Hof Method

Control

NO INTERVENTION

The control group received noch intervention throughout the intervention period.

Interventions

Wim Hof MethodBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male participants were eligible for the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being male
  • No underlying health conditions
  • Not using antihypertensive or other cardiovascular medications
  • Not engaging in regular exercise training
  • Written informed consent

You may not qualify if:

  • Having prior experience with any of the components of the intervention (breathing, meditation, or cold exposure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, 3012, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 40067458DERIVED

Study Officials

  • Sascha Ketelhut, PhD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of outcome assessors
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with parallel arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 8, 2023

Study Start

May 1, 2022

Primary Completion

July 30, 2022

Study Completion

September 30, 2022

Last Updated

June 8, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

All raw data are available on request to the corresponding author.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After the publication of the results for 5 years.
Access Criteria
PErsonal contact with corresponding author.

Locations

CH(1)