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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• both sexes

• age 18-65 yrs

• BMI \> 35 kg/m2

Locations
Other Locations
Italy
IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe
RECRUITING
Oggebbio
Contact Information
Primary
Paolo Capodaglio, Prof, MD
p.capodaglio@auxologico.it
+39 0323514331
Backup
Jacopo Maria Fontana, PhD
j.fontana@auxologico.it
+39 3534297935
Time Frame
Start Date: 2019-04-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 300
Treatments
Experimental: Rehabilitation
Multidisciplinary rehabilitation program consisting of diet and physical exercise for 4 weeks.
Experimental: Whole-Body Cryotherapy
Rehabilitation program consisting of 10 WBC sessions over two weeks.
Sponsors
Leads: Istituto Auxologico Italiano
Collaborators: Politecnico di Milano, Università degli Studi di Brescia

This content was sourced from clinicaltrials.gov