- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05894031
The Effectiveness of the Wim Hof Method
The Effectiveness of the Wim Hof Method on Cardiac Autonomic Function, Blood Pressure, Arterial Compliance, and Different Psychological Parameters
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3012
- University of Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being male
- No underlying health conditions
- Not using antihypertensive or other cardiovascular medications
- Not engaging in regular exercise training
- Written informed consent
Exclusion Criteria:
- Having prior experience with any of the components of the intervention (breathing, meditation, or cold exposure)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
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.
|
|
No Intervention: Control
The control group received noch intervention throughout the intervention period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
15 days
|
|
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.
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in the mean pulse wave velocity
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.
|
15 days
|
|
Change from baseline in the mean heart rate variability
Time Frame: 15 days
|
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.
|
15 days
|
|
Change from baseline in positive affect
Time Frame: 15 days
|
The German version of the Positive and Negative Affect Schedule was used.
|
15 days
|
|
Change from baseline in negative affect
Time Frame: 15 days
|
The German version of the Positive and Negative Affect Schedule was used.
|
15 days
|
|
Change in subjective vitality
Time Frame: 15 days
|
The German 6-item Version of the Subjective Vitality Scale was used.
|
15 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sascha Ketelhut, PhD, University of Bern
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- 2022-04-00004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
RAGE BioRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Wim Hof Method
-
Wayne State UniversityUnknownBipolar Disorder I | Bipolar Disorder II | Bipolar Affective Disorder, Currently in RemissionUnited States
-
NYU Langone HealthCompleted
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Radboud University Medical Center; Bernhoven HospitalCompleted
-
Stichting ReadeDr. C.J. Vaillant Fonds; W.M. de Hoop Stichting; Ars Donandi / Yske Walther fonds and other collaboratorsCompletedSpinal Cord InjuriesNetherlands
-
Radboud University Medical CenterCompleted
-
Comenius UniversityActive, not recruitingMultiple SclerosisSlovakia
-
October 6 UniversityNot yet recruitingSmoking Electronic Cigarettes (Vaping), With Moderate and High Dependence for NicotineEgypt
-
Cairo UniversityEnrolling by invitationExercise Training | Pulmonary | Respiratory AbnormalityLebanon
-
Gadjah Mada UniversityUnknownWater Immersion Method Colonoscopy in Unsedated PatientsIndonesia
-
Carmel Medical CenterCompleted