Spinal Cord Injuries
Conditions
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.
Interventions
OTHERWim 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.
Sponsors
Dr. C.J. Vaillant Fonds
W.M. de Hoop Stichting
Ars Donandi / Yske Walther fonds
Reade foundation
Stichting Reade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mental health | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mindful attention awareness | 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. |
| Change in hyperventilation | 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. |
| Change in pain and pain interference | 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. |
| Change in sleep quality | 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. |
| Change in hindrance due to spasticity | 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). |
| Change in CRP | Assessed before and after the 7-weeks WHM intervention | Concentration CRP (mg/L) in blood |
| Change in IL-6 | Assessed before and after the 7-weeks WHM intervention | Concentration IL-6 (pg/ml) in blood |
| Change in fasted glucose | Assessed before and after the 7-weeks WHM intervention | Concentration of fasted glucose (mmol/l) in blood |
| Change in triglycerides | Assessed before and after the 7-weeks WHM intervention | Concentration of triglycerides (mmol/l) in blood |
| Change in high-density lipoprotein | Assessed before and after the 7-weeks WHM intervention | Concentration of high-density lipoprotein (mmol/l) in blood |
| Change in health-related quality of life | 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. |
| Change in total cholesterol | Assessed before and after the 7-weeks WHM intervention | Concentration of total cholesterol (mmol/l) in blood |
| Change in blood pressure | Assessed before and after the 7-weeks WHM intervention | Systolic and diastolic blood pressure (mm Hg) |
| Change in forced vital capacity | Assessed before and after the 7-weeks WHM intervention | Forced vital capacity (FVC, liter) measured by spirometry |
| Change in forced expiratory volume | Assessed before and after the 7-weeks WHM intervention | Forced expiratory volume in 1 sec (FEV1, liter) measured by spirometry |
| Change in forced inspiratory volume | Assessed before and after the 7-weeks WHM intervention | Forced inspiratory volume in 1 sec (FIV1, liter) measured by spirometry |
| Change in peak expiratory flow | Assessed before and after the 7-weeks WHM intervention | Peak expiratory flow (PEF, liter/s) measured by spirometry |
| Change in peak inspiratory flow | Assessed before and after the 7-weeks WHM intervention | Peak inspiratory flow (PIF, liter/s) measured by spirometry |
| Change in body mass | Assessed before and after the 7-weeks WHM intervention | Body mass (kg) measured on a (wheelchair) weighing scale |
| Change in fat and fat free mass | Assessed before and after the 7-weeks WHM intervention | Fat mass and fat free mass (both in kg) measured by bio-impedance analysis: |
| Participant compliance and experiences | Assessed before and after the 7-weeks WHM intervention | Diary and exit interview |
| Change in low-density lipoprotein | Assessed before and after the 7-weeks WHM intervention | Concentration of low-density lipoprotein (mmol/l) in blood |
Countries
Netherlands
Outcome results
None listed