The primary objective of this 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,…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this RCT is to assess the effects of the WHM,
involving breathing exercises, mindset (and cold exposure), on health-related
quality of life.
Secondary outcome
The secondary objectives are to assess the effects of the WHM, involving
breathing exercises, mindset (and cold exposure) in people with SCI, on:
- markers of metabolic health;
- inflammation markers;
- pulmonary function;
- body composition;
- sleep quality;
- spasticity;
- chronic pain;
- stress.
Background summary
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.
Study objective
The primary objective of this 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
Randomized controlled trial.
Intervention
An RCT design will be used with two intervention groups and one control group.
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 WHM app. The first intervention group will
practice the breathing and mindset exercise while the second intervention group
will also practice the cold exposure (i.e, breathing, mindset and cold
exposure). The control group will not receive any intervention, they will
receive usual care and only participate in the pre and post tests.
Study burden and risks
Possible benefits of participating are lower levels of the inflammation
markers, improved respiratory function, less hindrance of spasticity, less pain
and stress and a better mood. Minor risks of the breathing exercises might be
fainting or becoming emotional. Participants will always perform the breathing
exercises in a supine position, therefore, there is no risk of falling when
fainting. During the pilot study, none of the participants has fainted.
Participants will slowly increase the amount of cold exposure. Supervision, by
a partner or caretaker, will be present the first time the cold washing cloths
or cold shower will be used
Overtoom 283
Amsterdam 1054 HW
NL
Overtoom 283
Amsterdam 1054 HW
NL
Listed location countries
Age
Inclusion criteria
- Having a complete or incomplete chronic spinal cord injury
- Age between 18 and 75 years
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 WHM intervention based
on the medical screening.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL81525.015.22 |