Stichting Reade
Amsterdam, 1054HW, Netherlands
NCT Number: NCT05704322
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Amsterdam, 1054HW, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Assessed before and after the 7-weeks WHM intervention
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
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
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
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
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
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
Concentration CRP (mg/L) in blood
Time frame: Assessed before and after the 7-weeks WHM intervention
Concentration IL-6 (pg/ml) in blood
Time frame: Assessed before and after the 7-weeks WHM intervention
Concentration of fasted glucose (mmol/l) in blood
Time frame: Assessed before and after the 7-weeks WHM intervention
Concentration of triglycerides (mmol/l) in blood
Time frame: Assessed before and after the 7-weeks WHM intervention
Concentration of high-density lipoprotein (mmol/l) in blood
Time frame: Assessed before and after the 7-weeks WHM intervention
Concentration of low-density lipoprotein (mmol/l) in blood
Time frame: Assessed before and after the 7-weeks WHM intervention
Concentration of total cholesterol (mmol/l) in blood
Time frame: Assessed before and after the 7-weeks WHM intervention
Systolic and diastolic blood pressure (mm Hg)
Time frame: Assessed before and after the 7-weeks WHM intervention
Forced vital capacity (FVC, liter) measured by spirometry
Time frame: Assessed before and after the 7-weeks WHM intervention
Forced expiratory volume in 1 sec (FEV1, liter) measured by spirometry
Time frame: Assessed before and after the 7-weeks WHM intervention
Forced inspiratory volume in 1 sec (FIV1, liter) measured by spirometry
Time frame: Assessed before and after the 7-weeks WHM intervention
Peak expiratory flow (PEF, liter/s) measured by spirometry
Time frame: Assessed before and after the 7-weeks WHM intervention
Peak inspiratory flow (PIF, liter/s) measured by spirometry
Time frame: Assessed before and after the 7-weeks WHM intervention
Body mass (kg) measured on a (wheelchair) weighing scale
Time frame: Assessed before and after the 7-weeks WHM intervention
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
Diary and exit interview
Stichting Reade
Other
The Effectiveness of the Wim Hof Method on Physical and Mental Health of People with a Spinal Cord Injury
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05589402
Bone Diseases, Brain Diseases
Harlingen, Texas, United States
View Trial DetailsNCT04350359
Central Nervous System Diseases, Female Urogenital Diseases
Washington D.C., District of Columbia, United States
View Trial DetailsNCT05822297
Central Nervous System Diseases, Cognition Disorders
Maastricht, Limburg, Netherlands
View Trial DetailsNCT04736849
Central Nervous System Diseases, Nervous System Diseases
Rochester, Minnesota, United States
View Trial Details