About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
both sexes
age 18-65 yrs
BMI > 35 kg/m2
Disqualifiers
severe psychiatric conditions
acute respiratory disease
acute cardiovascular disease
unstable hypertension
Trial design
Sequential
Treatments tested in this trial
Whole-body cryostimulation (WBC)
Other interventionMultidisciplinary rehabilitation program consisting of 10 WBC sessions.
Rehabilitation program
Other interventionMultidisciplinary rehabilitation program consisting of diet and physical exercise.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Change in skin temperatures after every session of WBC
The change in skin temperature of all body regions considered will be measured (nape of the neck, right quadriceps, right popliteal fossa, right calf) within 1 minute before and 1 minute after every session of WBC.
Change from baseline biochemical blood parameters HDL, LDL, Triglycerides and Glucose
Analysis of blood biochemical parameters HDL, LDL, Triglycerides and Glucose (mg/dl) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group).
Change from baseline biochemical blood parameter HBA1C%
Analysis of HBA1C% at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group).
Change from baseline systolic blood pressure and diastolic blood pressure (mmHg)
Measurement of systolic blood pressure (PAS), diastolic blood pressure (PAD) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group).
Sponsors and contacts
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Istituto Auxologico Italiano
Lead sponsor
Politecnico di Milano
Collaborator
Università degli Studi di Brescia
Collaborator