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

Primary Purpose

Spinal Cord Injuries

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Wim Hof Methode
Sponsored by
Stichting Reade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stichting Reade

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual care group

Wim Hof Method - breathing and mindset exercise

Wim Hof Method - breathing and mindset exercise and cold exposure

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).
Change in CRP
Concentration CRP (mg/L) in blood
Change in IL-6
Concentration IL-6 (pg/ml) in blood
Change in fasted glucose
Concentration of fasted glucose (mmol/l) in blood
Change in triglycerides
Concentration of triglycerides (mmol/l) in blood
Change in high-density lipoprotein
Concentration of high-density lipoprotein (mmol/l) in blood
Change in low-density lipoprotein
Concentration of low-density lipoprotein (mmol/l) in blood
Change in total cholesterol
Concentration of total cholesterol (mmol/l) in blood
Change in blood pressure
Systolic and diastolic blood pressure (mm Hg)
Change in forced vital capacity
Forced vital capacity (FVC, liter) measured by spirometry
Change in forced expiratory volume
Forced expiratory volume in 1 sec (FEV1, liter) measured by spirometry
Change in forced inspiratory volume
Forced inspiratory volume in 1 sec (FIV1, liter) measured by spirometry
Change in peak expiratory flow
Peak expiratory flow (PEF, liter/s) measured by spirometry
Change in peak inspiratory flow
Peak inspiratory flow (PIF, liter/s) measured by spirometry
Change in body mass
Body mass (kg) measured on a (wheelchair) weighing scale
Change in fat and fat free mass
Fat mass and fat free mass (both in kg) measured by bio-impedance analysis:
Participant compliance and experiences
Diary and exit interview

Full Information

First Posted
December 29, 2022
Last Updated
April 11, 2023
Sponsor
Stichting Reade
Collaborators
Dr. C.J. Vaillant Fonds, W.M. de Hoop Stichting, Ars Donandi / Yske Walther fonds, Reade foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05704322
Brief Title
The Effectiveness of the Wim Hof Method in People With Spinal Cord Injury
Official Title
The Effectiveness of the Wim Hof Method on Physical and Mental Health of People With a Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stichting Reade
Collaborators
Dr. C.J. Vaillant Fonds, W.M. de Hoop Stichting, Ars Donandi / Yske Walther fonds, Reade foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
The control group will not receive any intervention, they will receive usual care and only participate in the pre and post tests.
Arm Title
Wim Hof Method - breathing and mindset exercise
Arm Type
Experimental
Arm Description
The first intervention group will practice the breathing and mindset exercise.
Arm Title
Wim Hof Method - breathing and mindset exercise and cold exposure
Arm Type
Experimental
Arm Description
The second intervention group will also practice the cold exposure (i.e, breathing, mindset and cold exposure)
Intervention Type
Other
Intervention Name(s)
Wim Hof Methode
Intervention Description
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 Outcome Measure Information:
Title
Change in mental health
Description
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.
Time Frame
Assessed before and after the 7-weeks WHM intervention
Secondary Outcome Measure Information:
Title
Change in health-related quality of life
Description
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.
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in mindful attention awareness
Description
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.
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in hyperventilation
Description
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.
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in pain and pain interference
Description
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.
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in sleep quality
Description
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.
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in hindrance due to spasticity
Description
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).
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in CRP
Description
Concentration CRP (mg/L) in blood
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in IL-6
Description
Concentration IL-6 (pg/ml) in blood
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in fasted glucose
Description
Concentration of fasted glucose (mmol/l) in blood
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in triglycerides
Description
Concentration of triglycerides (mmol/l) in blood
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in high-density lipoprotein
Description
Concentration of high-density lipoprotein (mmol/l) in blood
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in low-density lipoprotein
Description
Concentration of low-density lipoprotein (mmol/l) in blood
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in total cholesterol
Description
Concentration of total cholesterol (mmol/l) in blood
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in blood pressure
Description
Systolic and diastolic blood pressure (mm Hg)
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in forced vital capacity
Description
Forced vital capacity (FVC, liter) measured by spirometry
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in forced expiratory volume
Description
Forced expiratory volume in 1 sec (FEV1, liter) measured by spirometry
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in forced inspiratory volume
Description
Forced inspiratory volume in 1 sec (FIV1, liter) measured by spirometry
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in peak expiratory flow
Description
Peak expiratory flow (PEF, liter/s) measured by spirometry
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in peak inspiratory flow
Description
Peak inspiratory flow (PIF, liter/s) measured by spirometry
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in body mass
Description
Body mass (kg) measured on a (wheelchair) weighing scale
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Change in fat and fat free mass
Description
Fat mass and fat free mass (both in kg) measured by bio-impedance analysis:
Time Frame
Assessed before and after the 7-weeks WHM intervention
Title
Participant compliance and experiences
Description
Diary and exit interview
Time Frame
Assessed before and after the 7-weeks WHM intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja de Groot, PhD
Organizational Affiliation
Stichting Reade
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stichting Reade
City
Amsterdam
ZIP/Postal Code
1054HW
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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