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

NCT ID: NCT05704322

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2024-12-01

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.

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Wim Hof Method - breathing and mindset exercise

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

Group Type: EXPERIMENTAL

Wim Hof Methode

Intervention Type: 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 and cold exposure

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

Group Type: EXPERIMENTAL

Wim Hof Methode

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. C.J. Vaillant Fonds

UNKNOWN

Sponsor Role: collaborator

W.M. de Hoop Stichting

UNKNOWN

Sponsor Role: collaborator

Ars Donandi / Yske Walther fonds

UNKNOWN

Sponsor Role: collaborator

Reade foundation

UNKNOWN

Sponsor Role: collaborator

Stichting Reade

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonja de Groot, PhD

Role: PRINCIPAL_INVESTIGATOR

Stichting Reade

Locations

Stichting Reade

Amsterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 38491303 (View on PubMed)

Other Identifiers

NL81525.015.22

Identifier Type: OTHER

Identifier Source: secondary_id

W22.069

Identifier Type: -

Identifier Source: org_study_id