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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05704322
• Other study ID #: W22.069
• Secondary ID: NL81525.015.22
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Stichting Reade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Stichting Reade	Amsterdam

Sponsors (5)

Lead Sponsor	Collaborator
Stichting Reade	Ars Donandi / Yske Walther fonds, Dr. C.J. Vaillant Fonds, Reade foundation, W.M. de Hoop Stichting

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in CRP	Concentration CRP (mg/L) in blood	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in IL-6	Concentration IL-6 (pg/ml) in blood	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in fasted glucose	Concentration of fasted glucose (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in triglycerides	Concentration of triglycerides (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in high-density lipoprotein	Concentration of high-density lipoprotein (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in low-density lipoprotein	Concentration of low-density lipoprotein (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in total cholesterol	Concentration of total cholesterol (mmol/l) in blood	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in blood pressure	Systolic and diastolic blood pressure (mm Hg)	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in forced vital capacity	Forced vital capacity (FVC, liter) measured by spirometry	Assessed before and after the 7-weeks WHM intervention
Secondary	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
Secondary	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
Secondary	Change in peak expiratory flow	Peak expiratory flow (PEF, liter/s) measured by spirometry	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in peak inspiratory flow	Peak inspiratory flow (PIF, liter/s) measured by spirometry	Assessed before and after the 7-weeks WHM intervention
Secondary	Change in body mass	Body mass (kg) measured on a (wheelchair) weighing scale	Assessed before and after the 7-weeks WHM intervention
Secondary	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
Secondary	Participant compliance and experiences	Diary and exit interview	Assessed before and after the 7-weeks WHM intervention