Spinal Cord InjuriesNCT05704322
The Effectiveness of the Wim Hof Method in People with Spinal Cord Injury
A study testing Wim Hof Methode in people with Spinal Cord Injuries, run by Stichting Reade at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Wim Hof Methode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Mar 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Wim Hof Method on Physical and Mental Health of People with a 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.
Read the 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
- Being tested
- Wim Hof Methode
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wim Hof MethodeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Other: Wim Hof Methode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed before and after the 7-weeks WHM intervention
Secondary outcomes (22)
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.
Measured: Assessed before and after the 7-weeks WHM intervention
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.
Measured: Assessed before and after the 7-weeks WHM intervention
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.
Measured: Assessed before and after the 7-weeks WHM intervention
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.
Measured: Assessed before and after the 7-weeks WHM intervention
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.
Measured: Assessed before and after the 7-weeks WHM intervention
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).
Measured: Assessed before and after the 7-weeks WHM intervention
Change in CRP
Concentration CRP (mg/L) in blood
Measured: Assessed before and after the 7-weeks WHM intervention
Change in IL-6
Concentration IL-6 (pg/ml) in blood
Measured: Assessed before and after the 7-weeks WHM intervention
Change in fasted glucose
Concentration of fasted glucose (mmol/l) in blood
Measured: Assessed before and after the 7-weeks WHM intervention
Change in triglycerides
Concentration of triglycerides (mmol/l) in blood
Measured: Assessed before and after the 7-weeks WHM intervention
Change in high-density lipoprotein
Concentration of high-density lipoprotein (mmol/l) in blood
Measured: Assessed before and after the 7-weeks WHM intervention
Change in low-density lipoprotein
Concentration of low-density lipoprotein (mmol/l) in blood
Measured: Assessed before and after the 7-weeks WHM intervention
Change in total cholesterol
Concentration of total cholesterol (mmol/l) in blood
Measured: Assessed before and after the 7-weeks WHM intervention
Change in blood pressure
Systolic and diastolic blood pressure (mm Hg)
Measured: Assessed before and after the 7-weeks WHM intervention
Change in forced vital capacity
Forced vital capacity (FVC, liter) measured by spirometry
Measured: Assessed before and after the 7-weeks WHM intervention
Change in forced expiratory volume
Forced expiratory volume in 1 sec (FEV1, liter) measured by spirometry
Measured: Assessed before and after the 7-weeks WHM intervention
Change in forced inspiratory volume
Forced inspiratory volume in 1 sec (FIV1, liter) measured by spirometry
Measured: Assessed before and after the 7-weeks WHM intervention
Change in peak expiratory flow
Peak expiratory flow (PEF, liter/s) measured by spirometry
Measured: Assessed before and after the 7-weeks WHM intervention
Change in peak inspiratory flow
Peak inspiratory flow (PIF, liter/s) measured by spirometry
Measured: Assessed before and after the 7-weeks WHM intervention
Change in body mass
Body mass (kg) measured on a (wheelchair) weighing scale
Measured: Assessed before and after the 7-weeks WHM intervention
Change in fat and fat free mass
Fat mass and fat free mass (both in kg) measured by bio-impedance analysis:
Measured: Assessed before and after the 7-weeks WHM intervention
Participant compliance and experiences
Diary and exit interview
Measured: Assessed before and after the 7-weeks WHM intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start27 Mar 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stichting Reade
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. C.J. Vaillant Fonds, W.M. de Hoop Stichting, Ars Donandi / Yske Walther fonds, Reade foundation
- Responsible party
- Sponsor
- Investigators
- Sonja de Groot, PhD, Principal investigator, Stichting Reade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704322
- Sponsor's protocol ID
- W22.069
- Other IDs
- NL81525.015.22
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2022
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38491303
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Wim Hof Method on Physical and Mental Health of People with a Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05704322
- Acronym / sponsor ID
- W22.069
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stichting ReadeUniversity, hospital or other
- Collaborators
- Dr. C.J. Vaillant Fonds, W.M. de Hoop Stichting, Ars Donandi / Yske Walther fonds, Reade foundation
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Wim Hof MethodeThe first intervention group will practice the breathing and mindset exercise. |
| Wim Hof Method - breathing and mindset exercise and cold exposure | Experimental | Other: Wim Hof MethodeThe second intervention group will also practice the cold exposure (i.e, breathing, mindset and cold exposure) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wim Hof MethodeThe 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. | Other | Wim Hof Method - breathing and mindset exercise, Wim Hof Method - breathing and mindset exercise and cold exposure |
Primary outcome
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.
22 secondary outcomes
Change in health-related quality of life
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in mindful attention awareness
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in hyperventilation
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in pain and pain interference
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in sleep quality
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in hindrance due to spasticity
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in CRP
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in IL-6
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in fasted glucose
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in triglycerides
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in high-density lipoprotein
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in low-density lipoprotein
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in total cholesterol
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in blood pressure
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in forced vital capacity
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in forced expiratory volume
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in forced inspiratory volume
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in peak expiratory flow
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in peak inspiratory flow
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in body mass
Time frame: Assessed before and after the 7-weeks WHM intervention
Change in fat and fat free mass
Time frame: Assessed before and after the 7-weeks WHM intervention
Participant compliance and experiences
Time frame: Assessed before and after the 7-weeks WHM intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 38491303Hoekstra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja de Groot, PhD principal investigator
Stichting Reade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wim Hof Methode in people with Spinal Cord Injuries, run by Stichting Reade at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mental health (time frame: Assessed before and after the 7-weeks WHM intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.