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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstituto Auxologico Italiano

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 volunteers

Qualifiers

both sexes

age 18-65 yrs

BMI > 35 kg/m2

Disqualifiers

severe psychiatric conditions

acute respiratory disease

acute cardiovascular disease

unstable hypertension

Trial design

Design model

Sequential

Treatments tested in this trial

  • Whole-body cryostimulation (WBC)

    Other intervention

    Multidisciplinary rehabilitation program consisting of 10 WBC sessions.

  • Rehabilitation program

    Other intervention

    Multidisciplinary rehabilitation program consisting of diet and physical exercise.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: RehabilitationExperimental treatment 1 intervention
Group B: Whole-Body CryotherapyExperimental treatment 2 interventions

Trial outcomes

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).

Time frame
up to 3 weeks

Secondary outcomes

1

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.

Time frame
up to 1 minute
2

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).

Time frame
up to 4 weeks
3

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).

Time frame
up to 4 weeks
4

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).

Time frame
up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Auxologico Italiano

Lead sponsor

Politecnico di Milano

Collaborator

Università degli Studi di Brescia

Collaborator