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

NCT05704322 | Completed

• 2 other identifiers: W22.069NL81525.015.22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Change in health-related quality of life

  Assessed before and after the 7-weeks WHM intervention

• Change in mindful attention awareness

  Assessed before and after the 7-weeks WHM intervention

• Change in hyperventilation

  Assessed before and after the 7-weeks WHM intervention

• Change in pain and pain interference

  Assessed before and after the 7-weeks WHM intervention

• Change in sleep quality

  Assessed before and after the 7-weeks WHM intervention

Study Arms (3)

Usual care group

NO INTERVENTION

The control group will not receive any intervention, they will receive usual care and only participate in the pre and post tests.

Wim Hof Method - breathing and mindset exercise

EXPERIMENTAL

The first intervention group will practice the breathing and mindset exercise.

Other: Wim Hof Methode

Wim Hof Method - breathing and mindset exercise and cold exposure

EXPERIMENTAL

The second intervention group will also practice the cold exposure (i.e, breathing, mindset and cold exposure)

Other: Wim Hof Methode

Interventions

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.

Wim Hof Method - breathing and mindset exercise; Wim Hof Method - breathing and mindset exercise and cold exposure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Stichting Reade

Amsterdam, 1054HW, Netherlands

Location

Related Publications (1)

• Hoekstra S, Ettema F, van der Bijll M, van der Sterren V, van Binsbergen E, van Orsouw L, Achterberg W, Daanen H, Janssen T, de Groot S. The effect of breathing exercises and mindset with or without cold exposure on mental and physical health in persons with a spinal cord injury-a protocol for a three-arm randomised-controlled trial. Spinal Cord. 2024 May;62(5):237-240. doi: 10.1038/s41393-024-00976-9. Epub 2024 Mar 15.

  PMID: 38491303 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sonja de Groot, PhD

  Stichting Reade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 30, 2023
• Study Start: March 27, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)