Impact of WBC on Patients With Metabolic or Neurological Diseases or Fibromyalgia (WBC-MeNeFi)
NCT ID: NCT05443100
Last Updated: 2025-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2019-04-01
2026-12-30
Brief Summary
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Detailed Description
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Participants: Using a consecutive sampling technique, the investigators will recruit patients for a comprehensive, multidisciplinary rehabilitation program for obesity. Patients of both sex, age 18-65 years with BMI \> 35 kg/m2 will be selected and consecutively evaluated for inclusion in the protocol. Exclusion criteria are: 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, and body temperature greater than 37.5°C. All patients will perform a multidisciplinary rehabilitation program (diet + exercise and physiotherapy).
Study design: Patients will be assigned to either a "rehabilitation + WBC" (RWBC) or "rehabilitation" intervention (R) group in a consecutive, non-randomized manner until the total sample for each group is reached (15 subjects per group).
Anthropometric values, body composition, plasma catecholamine concentration, demographic and hematological analyses, muscle strength and functional values of both groups will be assessed at admission (PRE-T0) and at discharge (POST-T10), two weeks later, for both groups within the hospital facility. They will undergo 10 sessions of WBC over two weeks (1 treatment per day, Monday through Friday, before exercise classes and physical therapy). Skin temperatures will be recorded immediately before and after each WBC exposure. Description of the WBC session: Study participants will be exposed to extremely cold, dry air at -110°C for 2-3 minutes in a cryochamber (Artic, CryoScience, Rome. The first WBC session will last 1 minute at -110°C to familiarize the patient with the cryochamber temperature, while all subsequent treatments will last 2 minutes. The patient's skin surface temperature at the neck, quadriceps, popliteal fossa, and calf will be measured before and after each treatment. The operator supervising the procedure will be in constant visual and vocal contact with the subjects. For safety reasons, the systolic and diastolic blood pressure of each participant will be measured before and after treatment.
Rehabilitation program: The multidisciplinary rehabilitation program will consist of individual nutritional intervention, psychological support, and supervised physical activity throughout hospitalization. All patients will receive a balanced hypocaloric Mediterranean diet with 18-20 % proteins, 27-30 % fats (of which \< 8% saturated fat) and 50-55 % carbohydrates (\< 15% simple sugars), and 30 g of fibers from fresh vegetables. The diet plan will be organized by the hospital dietitian into three meals: breakfast, lunch, and dinner, with an energy distribution of 20 %, 40 % and 40 %, respectively. Two daily 60-minute physiotherapy sessions consisting of personalized progressive aerobic training, postural control exercises and progressive strengthening exercises were performed under the supervision of a physiotherapist. The first aerobic session performed in the morning after WBC consists of walking at a self-selected cadence. The second session performed in the afternoon consists of arm-cranking at an intensity of 65% of HRmax according to the Karvonen equation ((220 - age) × 0.65).
Measurements. Demographic and clinical characteristics: Baseline demographic and clinical characteristics will be collected at the time of admission and will include age, sex, weight, height and body mass index (BMI).
Body Composition: Body composition will be assessed in the morning in a quiet room at a temperature of 22-25 °C using bioimpedentiometry (BIA) analyzes with the patient in a supine position with lower limbs slightly apart and empty bladder. Whole-body resistance (Rz) and reactance (Xc) will be measured by trained operators and these parameters will be assessed (in Kg and %): fat mass (FM), free fat mass (FFM), muscle mass (MM), appendicular skeletal muscle mass (ASMM).
Skin temperatures: The patient's skin surface temperature (°C) in at the neck,quadriceps, popliteal fossa, and calf will be measured before and after each WBC treatment.
Blood collection and Hematological/Biochemical analyses: Blood samples will be taken in the morning after overnight fasting conditions to determine plasma catecholamine levels (epinephrine, norepinephrine, dopamine, cortisol); red blood cell count (RBC), white blood cell count (WBC), platelet count (PLT), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), and mean platelet volume (MPV), complete blood count derived inflammatory biomarkers (NLR, dNLR, SII, AISI), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), TNF-α, cholesterol, HDL, LDL, glucose, insulin.
Performance-based physical functioning: to measure aerobic endurance, we will use the six-minute walk test (6MWT), performed indoors, along a 30-m, flat, undisturbed hospital corridor, with the length scored every 5 m. Chest pain, severe dyspnea, physical exhaustion, muscle cramps, sudden gait instability or other signs of severe distress are additional criteria for stopping the test. The Timed Up and Go test (TUG) test will be used to assess balance and functional mobility. The participant is asked to stand up from a standard chair, walk for 3 minutes, turn around, return to the chair, and sit down. The score corresponds to the time (seconds) taken to perform the test. Isometric strength will be assessed with the hand grip test using the American Society of Hand Therapists (ASHT) protocol as a reference.
Condition specific questionnaires will be administered to assess:
General health: Short-form health survey-36 (SF-36) and World Health Organization Well-being index (WHO5); pain: visual analogue scale (VAS), pain numeric rating scale (PNRS), brief pain inventory (BPI), central sensitization index (CSI), Promis global health scale, the Quantitative Analgesic Questionnaire (QAQ); fatigue: fatigue severity scale (FSS); sleep: Pittsburgh sleep quality index (PSQI), Promis sleep disturbance short form, Epworth Sleepiness Scale; Fibromyalgia Impact Questionnaire (FIQ) for the evaluation of fibromyalgia; Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) for the evaluation for patients with osteoarthritis; psychological weel-being, mood and depression: Psychological General Well-Being Index (PGWBI); State-Trait Anxiety Inventory (STAI); Depression, Anxiety and Stress Scale - 21 Items (DASS-21); Beck's Depression Inventory (BDI); Fear of movement: Tampa Scale of Kinesiophobia (TSK-I); Intestinal function: Wexner score; obesity-related disability: Test of Obesity-Related Disability (SIO Obesity-Related Disability Test, TSD-OC).
Statistical analysis: A sample of 15 obese adult individuals (BMI\>35 Kg/m2, age 18-65 years, both sexes) will be considered for each of the two groups, for a total of 30 individuals. Since there is no a priori data on this and it is a pilot study, the sample size was chosen based on the literature, which suggests considering a minimum number of 12 subjects for pilot studies.
To avoid confounding by BMI and age, patients will be matched for BMI and age to ensure an equal distribution between the groups of the variables believed to be confounding. Patients will not be blinded to study condition assignment.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Rehabilitation
Multidisciplinary rehabilitation program consisting of diet and physical exercise for 4 weeks.
Rehabilitation program
Multidisciplinary rehabilitation program consisting of diet and physical exercise.
Whole-Body Cryotherapy
Rehabilitation program consisting of 10 WBC sessions over two weeks.
Whole-body cryostimulation (WBC)
Multidisciplinary rehabilitation program consisting of 10 WBC sessions.
Rehabilitation program
Multidisciplinary rehabilitation program consisting of diet and physical exercise.
Interventions
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Whole-body cryostimulation (WBC)
Multidisciplinary rehabilitation program consisting of 10 WBC sessions.
Rehabilitation program
Multidisciplinary rehabilitation program consisting of diet and physical exercise.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-65 yrs
* BMI \> 35 kg/m2
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Politecnico di Milano
OTHER
Università degli Studi di Brescia
OTHER
Istituto Auxologico Italiano
OTHER
Responsible Party
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Principal Investigators
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Paolo Capodaglio, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Auxologico Italiano
Locations
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IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe
Oggebbio, Verbano-Cusio-Ossola, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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31C122
Identifier Type: -
Identifier Source: org_study_id
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