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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05894031
Other study ID # 2022-04-00004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date September 30, 2022

Study information

Verified date May 2023
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 parameters.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date September 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Wim Hof Method
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.

Locations

Country Name City State
Switzerland University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. 15 days
Secondary 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. 15 days
Secondary Change from baseline in positive affect The German version of the Positive and Negative Affect Schedule was used. 15 days
Secondary Change from baseline in negative affect The German version of the Positive and Negative Affect Schedule was used. 15 days
Secondary Change in subjective vitality The German 6-item Version of the Subjective Vitality Scale was used. 15 days
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