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WBC-MeNeFi
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
Sponsor study identifier
interventional
300
1 country
1
Study Start
April 1, 2019
Actual (reported)Primary Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2019
Actual (reported)June 21, 2022
Actual (reported)July 5, 2022
Actual (reported)December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from baseline blood catecholamine levels (epinephrine, norepinephrine and dopamine)
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).
up to 3 weeks
Change in skin temperatures after every session of WBC
up to 1 minute
Change from baseline biochemical blood parameters HDL, LDL, Triglycerides and Glucose
up to 4 weeks
Multidisciplinary rehabilitation program consisting of diet and physical exercise for 4 weeks.
Rehabilitation program consisting of 10 WBC sessions over two weeks.
Multidisciplinary rehabilitation program consisting of 10 WBC sessions.
Multidisciplinary rehabilitation program consisting of diet and physical exercise.
IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe
Oggebbio, Verbano-Cusio-Ossola, 28845, Italy
Thorp AA, Schlaich MP. Relevance of Sympathetic Nervous System Activation in Obesity and Metabolic Syndrome. J Diabetes Res. 2015;2015:341583. doi: 10.1155/2015/341583. Epub 2015 Apr 30.
Qi Z, Ding S. Obesity-associated sympathetic overactivity in children and adolescents: the role of catecholamine resistance in lipid metabolism. J Pediatr Endocrinol Metab. 2016 Feb;29(2):113-25. doi: 10.1515/jpem-2015-0182.
Paolo Capodaglio, Prof, MD
IRCCS Istituto Auxologico Italiano
First Submitted
June 21, 2022
First Posted
July 5, 2022
Study Start
April 1, 2019
Actual (reported)Primary Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change from baseline biochemical blood parameter HBA1C%
up to 4 weeks
Change from baseline systolic blood pressure and diastolic blood pressure (mmHg)
up to 4 weeks
Change from baseline heart rate variability (HRV) (bpm)
up to 4 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Fisher JP, Young CN, Fadel PJ. Central sympathetic overactivity: maladies and mechanisms. Auton Neurosci. 2009 Jun 15;148(1-2):5-15. doi: 10.1016/j.autneu.2009.02.003. Epub 2009 Mar 6.
Grassi G, Biffi A, Seravalle G, Trevano FQ, Dell'Oro R, Corrao G, Mancia G. Sympathetic Neural Overdrive in the Obese and Overweight State. Hypertension. 2019 Aug;74(2):349-358. doi: 10.1161/HYPERTENSIONAHA.119.12885. Epub 2019 Jun 17.
Fontana JM, Bozgeyik S, Gobbi M, Pitera P, Giusti EM, Dugue B, Lombardi G, Capodaglio P. Whole-body cryostimulation in obesity. A scoping review. J Therm Biol. 2022 May;106:103250. doi: 10.1016/j.jtherbio.2022.103250. Epub 2022 May 4.
White GE, Wells GD. Cold-water immersion and other forms of cryotherapy: physiological changes potentially affecting recovery from high-intensity exercise. Extrem Physiol Med. 2013 Sep 1;2(1):26. doi: 10.1186/2046-7648-2-26.
Hanssen MJ, van der Lans AA, Brans B, Hoeks J, Jardon KM, Schaart G, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Short-term Cold Acclimation Recruits Brown Adipose Tissue in Obese Humans. Diabetes. 2016 May;65(5):1179-89. doi: 10.2337/db15-1372. Epub 2015 Dec 30.
Wiecek M, Szymura J, Sproull J, Szygula Z. Whole-Body Cryotherapy Is an Effective Method of Reducing Abdominal Obesity in Menopausal Women with Metabolic Syndrome. J Clin Med. 2020 Aug 30;9(9):2797. doi: 10.3390/jcm9092797.
Lombardi G, Ziemann E, Banfi G. Whole-Body Cryotherapy in Athletes: From Therapy to Stimulation. An Updated Review of the Literature. Front Physiol. 2017 May 2;8:258. doi: 10.3389/fphys.2017.00258. eCollection 2017.
Costello JT, Baker PR, Minett GM, Bieuzen F, Stewart IB, Bleakley C. Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults. Cochrane Database Syst Rev. 2015 Sep 18;2015(9):CD010789. doi: 10.1002/14651858.CD010789.pub2.
Smolander J, Westerlund T, Uusitalo A, Dugue B, Oksa J, Mikkelsson M. Lung function after acute and repeated exposures to extremely cold air (-110 degrees C) during whole-body cryotherapy. Clin Physiol Funct Imaging. 2006 Jul;26(4):232-4. doi: 10.1111/j.1475-097X.2006.00675.x.
Banfi G, Melegati G, Barassi A, d'Eril GM. Effects of the whole-body cryotherapy on NTproBNP, hsCRP and troponin I in athletes. J Sci Med Sport. 2009 Nov;12(6):609-10. doi: 10.1016/j.jsams.2008.06.004. Epub 2008 Oct 2.
Gobbi M, Trotti G, Tanzi M, Kasap F, Pitera P, Capodaglio P. POST-COVID SYMPTOMS AND WHOLE-BODY CRYOTHERAPHY: A CASE REPORT. J Rehabil Med Clin Commun. 2022 Jan 13;5:1000075. doi: 10.2340/20030711-1000075. eCollection 2022. No abstract available.
Varallo G, Pitera P, Fontana JM, Gobbi M, Arreghini M, Giusti EM, Franceschini C, Plazzi G, Castelnuovo G, Capodaglio P. Is Whole-Body Cryostimulation an Effective Add-On Treatment in Individuals with Fibromyalgia and Obesity? A Randomized Controlled Clinical Trial. J Clin Med. 2022 Jul 26;11(15):4324. doi: 10.3390/jcm11154324.
Alito A, Fontana JM, Franzini Tibaldeo E, Verme F, Pitera P, Miller E, Cremascoli R, Brioschi A, Capodaglio P. Whole-Body Cryostimulation in Multiple Sclerosis: A Scoping Review. J Clin Med. 2024 Mar 29;13(7):2003. doi: 10.3390/jcm13072003.
Cerfoglio S, Verme F, Fontana JM, Alito A, Galli M, Capodaglio P, Cimolin V. Effects of whole-body cryostimulation on spinal and shoulder range of motion in individuals with obesity. Front Rehabil Sci. 2025 Jul 23;6:1568280. doi: 10.3389/fresc.2025.1568280. eCollection 2025.
Study Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 4, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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