Tests cold chamber sessions with rehabilitation in obesity, fibromyalgia or neurological disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 admitted for a rehabilitation program. It tests 10 sessions of whole-body cryostimulation (very cold air).

Age

18 to 65 years

Sex

Men and women

Disease stage

The inclusion list says BMI > 35 kg/m2. The summary also names obesity, fibromyalgia, osteoarthritis, Parkinson's disease, Multiple Sclerosis and disimmune polyneuropathies.

Earlier treatment

People with previous WBC treatment cannot join. A recent change in usual drug treatment is also an exclusion.

Main reasons for not taking part

• Severe psychiatric conditions
• Acute respiratory disease
• Acute cardiovascular disease or unstable hypertension
• Cold intolerance or claustrophobia
• Pregnancy

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 65 years old?YesNo

What the trial wants to find out

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).

The 2 groups in the trial

• RehabilitationTreatment being tested

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

  Treatment: Rehabilitation program

• Whole-Body CryotherapyTreatment being tested

  Rehabilitation program consisting of 10 WBC sessions over two weeks.

  Treatment: Whole-body cryostimulation (WBC) and Rehabilitation program