Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05443100

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

Led by Istituto Auxologico Italiano · Updated on 2025-08-04

300

Participants Needed

1

Research Sites

404 weeks

Total Duration

On this page

Sponsors

I

Istituto Auxologico Italiano

Lead Sponsor

P

Politecnico di Milano

Collaborating Sponsor

AI-Summary

What this Trial 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Both sexes
  • Age between 18 and 65 years
  • Body mass index (BMI) greater than 35 kg/m2
Not Eligible

You will not qualify if you...

  • Severe psychiatric conditions
  • Acute respiratory disease
  • Acute cardiovascular disease
  • Unstable hypertension
  • Cold intolerance
  • Claustrophobia
  • Pregnancy
  • Recent changes in usual drug treatment
  • Previous treatment with whole-body cryostimulation
  • Weight loss in the last 3 months
  • Body temperature higher than 37.5�B0C

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe

Oggebbio, Verbano-Cusio-Ossola, Italy, 28845

Actively Recruiting

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Research Team

P

Paolo Capodaglio, Prof, MD

CONTACT

J

Jacopo Maria Fontana, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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