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Completed

NCT Number: NCT05704322

The Effectiveness of the Wim Hof Method in People with 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Reade

Amsterdam, 1054HW, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wim Hof Methode

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. Change in CRP

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Concentration CRP (mg/L) in blood

  8. Change in IL-6

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Concentration IL-6 (pg/ml) in blood

  9. Change in fasted glucose

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Concentration of fasted glucose (mmol/l) in blood

  10. Change in triglycerides

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Concentration of triglycerides (mmol/l) in blood

  11. 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

  12. 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

  13. Change in total cholesterol

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Concentration of total cholesterol (mmol/l) in blood

  14. Change in blood pressure

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Systolic and diastolic blood pressure (mm Hg)

  15. Change in forced vital capacity

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Forced vital capacity (FVC, liter) measured by spirometry

  16. 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

  17. 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

  18. 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

  19. 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

  20. Change in body mass

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Body mass (kg) measured on a (wheelchair) weighing scale

  21. 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:

  22. Participant compliance and experiences

    Time frame: Assessed before and after the 7-weeks WHM intervention

    Diary and exit interview

Sponsors and collaborators

Lead sponsor

Stichting Reade

Other

Collaborators

  • Ars Donandi / Yske Walther fonds
  • Dr. C.J. Vaillant Fonds
  • Reade foundation
  • W.M. de Hoop Stichting

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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