The Effectiveness of the Wim Hof Method in People With Spinal Cord Injury

April 16, 2024 updated by: Stichting Reade

The Effectiveness of the Wim Hof Method on Physical and Mental Health of People With a Spinal Cord Injury

People with a spinal cord injury (SCI) often experience secondary medical complications. One of the methods that may help to prevent or deal with secondary complications in people with SCI is the Wim Hof Method (WHM). The WHM is based on three elements: 1) breathing exercises, 2) gradual cold exposure (cold showers, or cold water immersion), and 3) mindset. The primary objective of this randomized controlled trial is to assess the effects of WHM, involving breathing exercises, mindset (and cold exposure), on health-related quality of life in people with SCI. The secondary objectives are to assess the effects of WHM, involving breathing exercises, mindset (and cold exposure) in people with SCI on: inflammation markers, metabolic health, pulmonary function, body composition, sleep quality, spasticity, stress, and on chronic pain.

Study Overview

Status

Enrolling by invitation

Intervention / Treatment

Detailed Description

A spinal cord injury (SCI) is a serious medical condition that causes functional, psychological and socioeconomic disorder. Long-term, secondary medical complications are common and play an important role in the continuum of care for people with SCI. Complications are a frequent cause of morbidity and mortality and lead to increased rates of rehospitalisation, loss of employability and decreased quality of life. During multidisciplinary SCI rehabilitation, the treatment is focussed on working with the patient physically and psychologically to maximize their neurological recovery and general health but also to prevent or deal with the secondary complications. One of the methods that may help to prevent or deal with secondary complications in people with SCI is the Wim Hof Method (WHM). The WHM is based on three elements: 1) breathing exercises, 2) gradual cold exposure (cold showers, or cold water immersion), and 3) mindset. Previous studies showed a positive effect of the WHM on health-related quality of life and the inflammatory profile of healthy individuals as well as patients with active axial spondyloarthritis. Furthermore, a pilot study in people with SCI showed that the WHM (only breathing exercises and mindset) led to positive changes in respiratory function, mental health index, hyperventilation and a trend was visible regarding the hindrance due to spasticity. Some of the participants mentioned that they experienced positive effects on coughing, energy level, mood or used less spasticity medication after the WHM intervention. These positive findings in the pilot study warrant a full-scale randomised-controlled trial (RCT) of this novel therapeutic approach in people with SCI.

The primary objective of this randomized controlled trial is to assess the effects of WHM, involving breathing exercises, mindset (and cold exposure), on health-related quality of life in people with SCI. The secondary objectives are to assess the effects of WHM, involving breathing exercises, mindset (and cold exposure) in people with SCI on: inflammation markers, metabolic health, pulmonary function, body composition, sleep quality, spasticity, stress, and on chronic pain.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Amsterdam, Netherlands, 1054HW
        • Stichting Reade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals (Male/Female) with either a complete or incomplete chronic SCI. In this study, a chronic SCI is defined as a time since injury ≥ 1 year.
  • Participants have to be between 18 and 75 years old.

Exclusion Criteria:

  • Cardiac arrhythmias or cardiac disease;
  • A history of severe autonomic dysreflexia assessed with the 'Autonomic standards assessment';
  • Severe pulmonary disease (such as COPD) based on a pulmonary history;
  • Insufficient mastery of the Dutch language (speaking and reading);
  • Severe cognitive or communicative disorders;
  • Progressive disease;
  • Being or becoming pregnant during the study period;
  • Severe psychiatric illness or disorders (at the discretion of the treating rehabilitation physician);
  • Involved in another intervention study which may have an effect on the outcome measures of the present study;
  • Experience with (parts of) the Wim Hof Method.
  • Negative advice from physician to participate in the Wim Hof Method intervention based on the medical screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care group
The control group will not receive any intervention, they will receive usual care and only participate in the pre and post tests.
Experimental: Wim Hof Method - breathing and mindset exercise
The first intervention group will practice the breathing and mindset exercise.
The intervention groups will follow a 7-weeks intervention, with one practice session per week at the rehabilitation center led by Wim Hof or one of his instructors. Besides these joint weekly sessions, the intervention groups have to practice daily at home with the Wim Hof Method app.
Experimental: Wim Hof Method - breathing and mindset exercise and cold exposure
The second intervention group will also practice the cold exposure (i.e, breathing, mindset and cold exposure)
The intervention groups will follow a 7-weeks intervention, with one practice session per week at the rehabilitation center led by Wim Hof or one of his instructors. Besides these joint weekly sessions, the intervention groups have to practice daily at home with the Wim Hof Method app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mental health
Time Frame: Assessed before and after the 7-weeks WHM intervention
Mental Health Index - 5 (MHI-5), a subscale of the SF-36. The MHI-5 has a score of 0 to 100, where a score of 100 represents optimal mental health.
Assessed before and after the 7-weeks WHM intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in health-related quality of life
Time Frame: Assessed before and after the 7-weeks WHM intervention
The SF-36 measures measures eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each scale is scored on a 0 to 100 range, a higher score defines a more favorable health state.
Assessed before and after the 7-weeks WHM intervention
Change in mindful attention awareness
Time Frame: Assessed before and after the 7-weeks WHM intervention
The Mindful Attention Awareness Scale is a 15-item scale designed to assess a core characteristic of mindfulness. Each item can be scored from 1 (almost always) to 6 (almost never). The overall outcome is the average of the 15 items, with a higher score indicating being more mindful.
Assessed before and after the 7-weeks WHM intervention
Change in hyperventilation
Time Frame: Assessed before and after the 7-weeks WHM intervention
The Nijmegen Hyperventilation Syndrome Questionnaire has 16 items (related to symptoms of hyperventilation syndrome) to be answered on a 5-point scale ranging from 'never' (0) to 'very often' (4). A total score of more than 23 out of 64 points suggests significant hyperventilation.
Assessed before and after the 7-weeks WHM intervention
Change in pain and pain interference
Time Frame: Assessed before and after the 7-weeks WHM intervention
Four questions of the International Spinal Cord Injury Pain basic data set will be used to assess (the interference of) pain on a 0 (no pain or no interference) to 10 (extreme pain or extreme interference) range.
Assessed before and after the 7-weeks WHM intervention
Change in sleep quality
Time Frame: Assessed before and after the 7-weeks WHM intervention
Pittsburgh Sleep Quality Index (PSQI) is a self-rating questionnaire resulting in a global score between 0 and 21, which consists of seven subscores. Higher scores indicate worse sleep quality.
Assessed before and after the 7-weeks WHM intervention
Change in hindrance due to spasticity
Time Frame: Assessed before and after the 7-weeks WHM intervention
Hindrance due to spasticity will be assessed with a subjective rating scale for each of the following activities: (1) sleeping; (2) making transfers; (3) washing and clothing; (4) wheelchair driving; (5) 'others'. The scale ranges from 0 to 2 (0: no hindrance due to spasticity; 1: little hindrance due to spasticity; 2: a lot of hindrance due to spasticity). A sum score for hindrance during all activities will be calculated. It ranges from 0 (no hindrance) to 10 (a lot of hindrance during all activities).
Assessed before and after the 7-weeks WHM intervention
Change in CRP
Time Frame: Assessed before and after the 7-weeks WHM intervention
Concentration CRP (mg/L) in blood
Assessed before and after the 7-weeks WHM intervention
Change in IL-6
Time Frame: Assessed before and after the 7-weeks WHM intervention
Concentration IL-6 (pg/ml) in blood
Assessed before and after the 7-weeks WHM intervention
Change in fasted glucose
Time Frame: Assessed before and after the 7-weeks WHM intervention
Concentration of fasted glucose (mmol/l) in blood
Assessed before and after the 7-weeks WHM intervention
Change in triglycerides
Time Frame: Assessed before and after the 7-weeks WHM intervention
Concentration of triglycerides (mmol/l) in blood
Assessed before and after the 7-weeks WHM intervention
Change in high-density lipoprotein
Time Frame: Assessed before and after the 7-weeks WHM intervention
Concentration of high-density lipoprotein (mmol/l) in blood
Assessed before and after the 7-weeks WHM intervention
Change in low-density lipoprotein
Time Frame: Assessed before and after the 7-weeks WHM intervention
Concentration of low-density lipoprotein (mmol/l) in blood
Assessed before and after the 7-weeks WHM intervention
Change in total cholesterol
Time Frame: Assessed before and after the 7-weeks WHM intervention
Concentration of total cholesterol (mmol/l) in blood
Assessed before and after the 7-weeks WHM intervention
Change in blood pressure
Time Frame: Assessed before and after the 7-weeks WHM intervention
Systolic and diastolic blood pressure (mm Hg)
Assessed before and after the 7-weeks WHM intervention
Change in forced vital capacity
Time Frame: Assessed before and after the 7-weeks WHM intervention
Forced vital capacity (FVC, liter) measured by spirometry
Assessed before and after the 7-weeks WHM intervention
Change in forced expiratory volume
Time Frame: Assessed before and after the 7-weeks WHM intervention
Forced expiratory volume in 1 sec (FEV1, liter) measured by spirometry
Assessed before and after the 7-weeks WHM intervention
Change in forced inspiratory volume
Time Frame: Assessed before and after the 7-weeks WHM intervention
Forced inspiratory volume in 1 sec (FIV1, liter) measured by spirometry
Assessed before and after the 7-weeks WHM intervention
Change in peak expiratory flow
Time Frame: Assessed before and after the 7-weeks WHM intervention
Peak expiratory flow (PEF, liter/s) measured by spirometry
Assessed before and after the 7-weeks WHM intervention
Change in peak inspiratory flow
Time Frame: Assessed before and after the 7-weeks WHM intervention
Peak inspiratory flow (PIF, liter/s) measured by spirometry
Assessed before and after the 7-weeks WHM intervention
Change in body mass
Time Frame: Assessed before and after the 7-weeks WHM intervention
Body mass (kg) measured on a (wheelchair) weighing scale
Assessed before and after the 7-weeks WHM intervention
Change in fat and fat free mass
Time Frame: Assessed before and after the 7-weeks WHM intervention
Fat mass and fat free mass (both in kg) measured by bio-impedance analysis:
Assessed before and after the 7-weeks WHM intervention
Participant compliance and experiences
Time Frame: Assessed before and after the 7-weeks WHM intervention
Diary and exit interview
Assessed before and after the 7-weeks WHM intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Sonja de Groot, PhD, Stichting Reade

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Estimated)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • W22.069
  • NL81525.015.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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