Clinical trial

Impact of WBC on Patients With Metabolic or Neurological Diseases or Fibromyalgia (WBC-MeNeFi)

Recruiting now · Not applicable · 1 countries · Registry ID NCT05443100

Recruiting nowNot applicableInterventional

What this study is about

The purpose of this clinical trial is to investigate on different types of patients the effects of 10 sessions of whole-body cryostimulation (WBC): 1) in patients with obesity (BMI \> 30), we want to investigate whether WBC increases thermogenesis, basal metabolic rate (BMR), respiratory quotient (which indirectly provides an estimate of energy substrate oxidation), reduces chronic inflammatory status, fatigue and pain, and improves functional abilities and general physical and psychological capacities; 2) in patients diagnosed with fibromyalgia and/or osteoarthrytis, we want to investigate the reduction of pain, inflammatory status, increase in functional capacity and general physical and psychological abilities, and improvement in mood; 3) in neurological patients diagnosed with Parkinson's disease, Multiple Sclerosis, and Disimmune Polyneuropathies, the effects of WBC on pain, fatigue, and sleep quality are to be investigated; 4) in normal/overweight (BMI\<30 kg/m2) subjects, the effects of WBC on all parameters described previously for the other protocols are to be investigated. Specifically, for all enrolled subjects, we want to assess blood catecholamine levels, investigate the effects of sympathetic response on body composition, blood pressure, heart rate, lipid profile, and physical performance. Three hundred patients admitted for a rehabilitation program (diet + physiotherapy + exercise) will be non-randomly assigned to either a group following the program (R) or a group additionally receiving ten 2-3 minute WBC sessions at -110°C over two weeks (RWBC).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Fibromyalgia, Neurological Conditions

Full registry criteria

Inclusion Criteria: * both sexes * age 18-65 yrs * BMI \> 35 kg/m2 Exclusion Criteria: * severe psychiatric conditions * acute respiratory disease * acute cardiovascular disease * unstable hypertension * cold intolerance * claustrophobia * pregnancy * recent modification of usual drug treatment * previous treatment with WBC * weight loss in the last 3 months * body temperature greater than 37.5°C.

Treatments and study arms

Whole-body cryostimulation (WBC)

Other

Multidisciplinary rehabilitation program consisting of 10 WBC sessions.

Rehabilitation program

Other

Multidisciplinary rehabilitation program consisting of diet and physical exercise.

Primary outcomes

Change from baseline blood catecholamine levels (epinephrine, norepinephrine and dopamine)up to 3 weeks

Catecholamine levels (ng/ml) in plasma samples will be measured at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe🇮🇹 Oggebbio, Verbano-Cusio-Ossola, Italy

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Jacopo Maria Fontana, PhDContact

Email · Call +393534297935

Paolo PiteràSub Investigator

Amelia BrunaniSub Investigator