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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05443100
Other study ID # 31C122
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source Istituto Auxologico Italiano
Contact Paolo Capodaglio, Prof, MD
Phone +39 0323514331
Email p.capodaglio@auxologico.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 capacity; 2) in patients diagnosed with fibromyalgia, we want to investigate the reduction of pain, inflammatory status, increase in functional abilities and general physical abilities functional status and an 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).


Description:

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Study Design


Intervention

Other:
Whole-body cryostimulation (WBC)
Multidisciplinary rehabilitation program consisting of 10 WBC sessions.
Rehabilitation program
Multidisciplinary rehabilitation program consisting of diet and physical exercise.

Locations

Country Name City State
Italy IRCCS Istituto Auxologico Italiano Ospedale San Giuseppe Oggebbio Verbano-Cusio-Ossola

Sponsors (3)

Lead Sponsor Collaborator
Istituto Auxologico Italiano Politecnico di Milano, Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (15)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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). up to 3 weeks
Secondary 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. up to 1 minute
Secondary 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). up to 4 weeks
Secondary 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). up to 4 weeks
Secondary 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). up to 4 weeks
Secondary Change from baseline heart rate variability (HRV) (bpm) Measurement of hear rate (HR) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group). up to 4 weeks
Secondary Change from baseline weight Measurement of Weight (kg) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group). up to 4 weeks
Secondary Change from baseline BMI Measurement of BMI (kg/m2) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group). up to 4 weeks
Secondary Change from baseline waist circumference Measurement of waist circumference (cm) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group). up to 4 weeks
Secondary Change from baseline % of Fat Mass (FM), Free Fat Mass (FFM) and Muscle Mass (MM) Measurement of FM, MM and FFM % at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group). up to 4 weeks
Secondary Change from baseline aerobic endurance Measurement of aerobic endurance using the six-minute walk test (m) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group). up to 4 weeks
Secondary Change from baseline balance and functional mobility Measurement of balance and functional mobility using the Timed Up and Go test (sec) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group). up to 4 weeks
Secondary Change from baseline isometric strength Measurement of isometric strength using the hand grip test (kg) at baseline and two weeks later, after multidisciplinary rehabilitation (R group) or multidisciplinary rehabilitation + WBC (RWBC group). up to 4 weeks
Secondary Change from baseline of subjective well-being Patients' subjective well-being was assessed using the World Health Organization's self-administered questionnaire: Five Well-Being Index (WHO-5). The raw score ranges from 0 to 25, where 0 represents the worst possible quality of life and 25 represents the best possible quality of life. up to 12 months
Secondary Change from baseline of subjective psychological well-being Patients' subjective psychological well-being was assessed using the Psychological General Well-Being Index (PGWBI), a 22-item self-report questionnaire designed to measure subjective well-being or distress over the past 28 days. The items reflect the six subscales: anxiety, depression, positive well-being, self-control, general health and vitality, comprising 5, 3, 4, 3, 3 and 4 items, respectively. A 6-point Likert scale (0 to 5) provides a total and subscale score of up to 110 points, where higher scores indicate better PGWB. PGWBI scores were grouped into the following categories: 0-60 Severe Distress, 61-71 Moderate Distress, 72-92 No Distress, and 93-110 PWB. up to 12 months
Secondary Change from baseline of the obesity-related disability Obesity-related disability is assessed using the Test of Obesity-Related Disability (SIO Obesity-Related Disability Test, TSD-OC). The TSD-OC consists of 7 sections with a total of 36 items exploring the following dimensions of disability: pain, stiffness, ADL and mobility in the home, activities in the home, activities outside the home, work activities, and social life.
The patient is asked to subjectively rate the disability for each item by means of a visual analog scale (VAS): a value of 10 indicates the highest level of disability and a value of 0 the absence of difficulty in performing that particular function. A person's degree of disability is assessed by relating the score obtained to the maximum score obtainable (360). A person is considered disabled if he or she has a disability score greater than 33% or has a score =8/10 in any of the items.
up to 12 months
Secondary Change from baseline of the impact of fibromyalgia The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus, the maximum possible score is 100. The average score for a patient with fibromyalgia is about 50; patients with severe conditions usually have a score of more than 70. up to 12 months
Secondary Change from baseline of the conditions of patients with hip and knee osteoarthritis Patients are asked to fill out the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC, only for patients with osteoarthritis). The score obtained varies from 0 to 96 depending on the symptomatology described. Statistical analysis of the WOMAC values before and after the considered treatments allows us to evaluate the effectiveness of the treatments.
Patients are asked to fill out Short Form 36, a questionnaire constructed to detect health status. Each item on the questionnaire is rated, and a higher number indicates that the person enjoys better overall health. In addition, each item is rated on a scale of 0 to 100, with 0 and 100 being the lowest and highest possible scores. The scores indicate the percentage of the possible score that was actually achieved.
up to 12 months
Secondary Changes from baseline in self-assessment of quality of life The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus, the maximum possible score is 100. The average score for a patient with fibromyalgia is about 50; patients with severe conditions usually have a score of more than 70. up to 12 months
Secondary Change from baseline of subjective sleep quality Patients' subjective improvement in sleep quality is assessed using the following self-administered questionnaires: Pittsburgh sleep quality index (PSQI).
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
up to 12 months
Secondary Change from baseline of subjective pain level Subjective pain level improvement is measured using the Pain Numeric Rating Scale (PNRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). up to 12 months
Secondary Change from baseline of chronic pain Chronic pain improvement is measured only in patients with chronic pain using the Brief Pain Inventory (BPI). The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items.
The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
up to 12 months
Secondary Change from baseline of the use of pain medications The use of pain medications is assessed using the Quantitative Analgesic Questionnaire The Quantitative Analgesic Questionnaire (QAQ) is a instrument designed to comprehensively document patient-reported medication use, generate scores to quantify it (by individual drug, class, and/or overall), and compare it (qualitatively and/or quantitatively) to the regimen as prescribed. up to 12 months
Secondary Change from baseline of subjective fatigue perception The impact of fatigue on patients was evaluated using the fatigue severity scale. The raw score ranges from 9 to 63. A total score of less than 36 suggests that the subject may not be suffering from fatigue while a total score of 36 or more suggests further evaluation by a physician.
Based on the frequency of episodes, a score of 0 to 4 points is given for the reported parameters up to a maximum of 20 (severe fecal incontinence) to obtain which all steps considered must be indicated and summed
up to 12 months
Secondary Change from baseline of the subjective quantification of the fear of movement The quantification of the fear of movement is assessed using the Tampa Scale of Kinesiophobia (TSK-I).
The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
up to 12 months
Secondary Change from baseline in depression Depression is assessed using the Beck Depression Inventory (BDI). The highest positive score can be 63, the lowest 0. The standard cut-off scores were as follows: 0-9: indicates minimal depression. 10-18: indicates mild depression. 19-29: indicates moderate depression.
The highest positive score can be 63, the lowest 0. The cut-off is 17 points.
up to 12 months
Secondary Change from baseline in anxiety Anxiety is assessed using the State-Trait Anxiety Inventory (STAI). Scores range from 20 to 80, with higher scores correlating with greater anxiety. up to 12 months
Secondary Change from baseline in the sleep condition Sleep condition is assessed using the Sleep Condition Indicator (SCI). Scores range from 0 to 32 with scores = 16 considered indicative of insomnia disorder in the general population Sleep condition is assessed using the Sleep Condition Indicator (SCI). Scores range from 0 to 32. up to 12 months
Secondary Change from baseline of subjective sleepiness Patients' subjective sleepiness is assessed using the Epworth Sleepiness Scale. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. 1 to 6 points: Normal sleep; 7 to 8 points: Average sleepiness; 9 to 24 points: Abnormal (possibly pathologic) sleepiness. up to 12 months
Secondary Change from baseline in Depression, Anxiety and Stress Depression, anxiety and stress are assessed using the Depression, Anxiety and Stress Scale - 21 Items (DASS-21). Scores range from 0 to 32 for every item (Depression, Anxiety and Stress). The total score represents overall distress (0 to 30), with higher scores indicating more severe distress or a greater number of symptoms. Two subscales are presented: Anxiety-Stress: Items 1, 4, 6, 7, 8, 9 (raw score range = 0 to 18) Depression: Items 2, 3, 5, 10 (raw score range = 0 to 12) up to 12 months
Secondary Change from baseline in Central Sensitization Inventory (CSI) Central Sensitization Inventory is a self-report outcome measure designed to identify patients who have symptoms that may be related to Central Sensitisation (CS) or central sensitivity syndromes (CSS). Responses are recorded about the frequency of each symptom, with a Likert scale from 0 (never) to 4 (always), resulting in a total possible score of 100. Higher scores are associated with a higher degree of self-reported symptomology. up to 12 months
Secondary Change from baseline in intestinal function Constipation symptoms are assessed using the Wexner score. Based on the frequency of episodes, a score of 0 to 4 points is given for the reported parameters up to a maximum of 20 (severe fecal incontinence) to obtain which all steps considered must be indicated and summed up to 12 months
Secondary Follow-up questionnaires or telephone interviews The subjective improvement of patients is assessed through the administration of questionnaires or follow-up telephone interviews on general health and well-being, quality of life, sleep quality, pain level, use of medications, fatigue and psychological aspects (i.e. depression and anxiety). up to 12 months
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