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

Recruiting now · Not applicable

Conditions studied: Obesity, Fibromyalgia, Neurological Conditions

In brief

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).

Key facts

Study ID

NCT05443100

Run by

Istituto Auxologico Italiano

People needed

300

Starts

2019-04-01

Expected to finish

2026-12-30

Last updated by the study team

2025-08-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• both sexes
• age 18-65 yrs
• BMI > 35 kg/m2

You may not qualify if…

• 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.

Where it is running

• IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe — Oggebbio, Verbano-Cusio-Ossola, Italy (enrolling)

Full record on ClinicalTrials.gov

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