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

NCT05443100 | Recruiting

• 1 other identifier: 31C122
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Obesity; Fibromyalgia; Neurological Conditions

Keywords

Whole-Body cryostimulation; Obesity; Rehabilitation; Catecholamines; Thermal stress

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (34)

• 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

• 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

Study Arms (2)

Rehabilitation

EXPERIMENTAL

Multidisciplinary rehabilitation program consisting of diet and physical exercise for 4 weeks.

Other: Rehabilitation program

Whole-Body Cryotherapy

EXPERIMENTAL

Rehabilitation program consisting of 10 WBC sessions over two weeks.

Other: Whole-body cryostimulation (WBC); Other: Rehabilitation program

Interventions

Whole-body cryostimulation (WBC) OTHER

Multidisciplinary rehabilitation program consisting of 10 WBC sessions.

Also known as: Whole-body cryotherapy

Whole-Body Cryotherapy

Rehabilitation program OTHER

Multidisciplinary rehabilitation program consisting of diet and physical exercise.

Also known as: Multidisciplinary Rehabilitation program

Rehabilitation; Whole-Body Cryotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Politecnico di Milano: collaborator
• Università degli Studi di Brescia: collaborator

Study Sites (1)

IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe

Oggebbio, Verbano-Cusio-Ossola, 28845, Italy

RECRUITING

Related Publications (16)

• 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.

  PMID: 26064978 BACKGROUND

• 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.

  PMID: 26488603 BACKGROUND

• 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.

  PMID: 19268634 BACKGROUND

• 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.

  PMID: 31203727 BACKGROUND

• 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.

  PMID: 35636880 BACKGROUND

• 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.

  PMID: 24004719 BACKGROUND

• 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.

  PMID: 26718499 BACKGROUND

• 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.

  PMID: 32872598 BACKGROUND

• 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.

  PMID: 28512432 BACKGROUND

• 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.

  PMID: 26383887 BACKGROUND

• 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.

  PMID: 16836696 BACKGROUND

• 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.

  PMID: 18835219 BACKGROUND

• 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.

  PMID: 35154582 BACKGROUND

• 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.

  PMID: 35893415 BACKGROUND

• 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.

  PMID: 38610768 BACKGROUND

• 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.

  PMID: 40772266 DERIVED

MeSH Terms

Conditions

Obesity; Fibromyalgia

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Paolo Capodaglio, Prof, MD

  IRCCS Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Capodaglio, Prof, MD

CONTACT

+39 0323514331; p.capodaglio@auxologico.it

Jacopo Maria Fontana, PhD

CONTACT

+39 3534297935; j.fontana@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 5, 2022
• Study Start: April 1, 2019
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)