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

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: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Wim Hof Methode

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 (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1054HW
    • Stichting Reade

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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.	Other: Wim Hof Methode; 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)	Other: Wim Hof Methode; 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	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	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	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	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	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	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	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	Concentration CRP (mg/L) in blood	Assessed before and after the 7-weeks WHM intervention
Change in IL-6	Concentration IL-6 (pg/ml) in blood	Assessed before and after the 7-weeks WHM intervention
Change in fasted glucose	Concentration of fasted glucose (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Change in triglycerides	Concentration of triglycerides (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Change in high-density lipoprotein	Concentration of high-density lipoprotein (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Change in low-density lipoprotein	Concentration of low-density lipoprotein (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Change in total cholesterol	Concentration of total cholesterol (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Change in blood pressure	Systolic and diastolic blood pressure (mm Hg)	Assessed before and after the 7-weeks WHM intervention
Change in forced vital capacity	Forced vital capacity (FVC, liter) measured by spirometry	Assessed before and after the 7-weeks WHM intervention
Change in forced expiratory volume	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	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	Peak expiratory flow (PEF, liter/s) measured by spirometry	Assessed before and after the 7-weeks WHM intervention
Change in peak inspiratory flow	Peak inspiratory flow (PIF, liter/s) measured by spirometry	Assessed before and after the 7-weeks WHM intervention
Change in body mass	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	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	Diary and exit interview	Assessed before and after the 7-weeks WHM intervention

Collaborators and Investigators

• Sponsor: Stichting Reade
• Collaborators: Dr. C.J. Vaillant Fonds; W.M. de Hoop Stichting; Ars Donandi / Yske Walther fonds; Reade foundation
• Investigators: Principal Investigator: Sonja de Groot, PhD, Stichting Reade

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

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 (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• 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
• product manufactured in and exported from the U.S.: No