Effects of whole-body cryostimulation on patients with obesity, fibromyalgia, and neurological conditions
A Non-randomized Pilot Study of the Impact on Rehabilitation Outcomes of a Course of Whole-body Cryostimulation (WBC) Treatment on Patients With Metabolic or Neurological Diseases or Fibromyalgia
This study is testing if whole-body cryostimulation can help people with obesity, fibromyalgia, and neurological conditions feel better by reducing pain and inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Oggebbio, Verbano-Cusio-Ossola) |
| Trial ID | NCT05443100 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of 10 sessions of whole-body cryostimulation (WBC) on patients with obesity, fibromyalgia, and various neurological conditions. The study aims to assess whether WBC can enhance thermogenesis, reduce inflammation, alleviate pain, and improve functional and psychological capacities in these patient populations. Participants will include individuals with a BMI greater than 30, as well as those diagnosed with fibromyalgia and neurological disorders such as Parkinson's disease and Multiple Sclerosis. The trial is conducted by Istituto Auxologico Italiano, which focuses on innovative therapeutic modalities for rehabilitation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a BMI greater than 35 who are experiencing obesity-related complications or have fibromyalgia or neurological conditions.
Not a fit: Patients with severe psychiatric conditions, acute respiratory or cardiovascular diseases, or those who have recently lost weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option that improves physical and psychological well-being for patients suffering from obesity, fibromyalgia, and neurological disorders.
How similar studies have performed: While the approach of using whole-body cryostimulation is innovative, previous studies have indicated potential benefits in reducing inflammation and improving symptoms in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oggebbio, Verbano-Cusio-Ossola
- IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe — Oggebbio, Verbano-Cusio-Ossola, Italy (Recruiting)
Study contacts
- Principal investigator: Paolo Capodaglio, Prof, MD — IRCCS Istituto Auxologico Italiano
- Study coordinator: Paolo Capodaglio, Prof, MD
- Email: p.capodaglio@auxologico.it
- Phone: +39 0323514331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.