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

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

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

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

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

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).

Time frame: up to 4 weeks

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).

Time frame: up to 4 weeks

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).

Time frame: up to 4 weeks

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).

Time frame: up to 4 weeks

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).

Time frame: up to 4 weeks

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).

Time frame: up to 4 weeks

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).

Time frame: up to 4 weeks

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).

Time frame: up to 4 weeks

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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").

Time frame: up to 12 months

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.

Time frame: up to 12 months

Change from baseline of the use of pain medications

The use of pain medications is assessed using 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.

Time frame: up to 12 months

Change from baseline of subjective fatigue perception

The impact of fatigue on patients was evaluated using the fatigue severity scale (FSS). 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

Time frame: up to 12 months

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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.

Time frame: up to 12 months

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)

Time frame: up to 12 months

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.

Time frame: up to 12 months

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

Time frame: up to 12 months

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).

Time frame: up to 12 months

Change from baseline Sleep Disturbance

Patients' sleep disturbance is assessed using the PROMIS Sleep Disturbance Short Form survey. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.

Time frame: up to 12 months

Change from baseline Global Health

Patients' global health is assessed using the PROMIS Global Health Scale. The possible score ranges from 0 to 20 points in each case. 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health.

Time frame: up to 12 months

Change from baseline health status

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.

Time frame: up to 12 months