Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Both sexes
- Age between 18 and 65 years
- Body mass index (BMI) greater than 35 kg/m2
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe
Oggebbio, Verbano-Cusio-Ossola, Italy, 28845
Actively Recruiting
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here