Clinical trial NCT05704322: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Stichting Reade
Sponsor class: OTHER
Collaborators: name: Dr. C.J. Vaillant Fonds
name: W.M. de Hoop Stichting
name: Ars Donandi / Yske Walther fonds
name: Reade foundation
First posted: 2023-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in mental health
timeFrame: Assessed before and after the 7-weeks WHM intervention
Secondary outcomes:
measure: Change in health-related quality of life
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in mindful attention awareness
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in hyperventilation
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in pain and pain interference
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in sleep quality
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in hindrance due to spasticity
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in CRP
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in IL-6
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in fasted glucose
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in triglycerides
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in high-density lipoprotein
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in low-density lipoprotein
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in total cholesterol
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in blood pressure
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in forced vital capacity
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in forced expiratory volume
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in forced inspiratory volume
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in peak expiratory flow
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in peak inspiratory flow
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in body mass
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Change in fat and fat free mass
timeFrame: Assessed before and after the 7-weeks WHM intervention
measure: Participant compliance and experiences
timeFrame: Assessed before and after the 7-weeks WHM intervention
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Stichting Reade
Study officials:
affiliation: Stichting Reade
name: Sonja de Groot, PhD
role: PRINCIPAL_INVESTIGATOR
References: