Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: *Overweight and obese patients under 60 years old *BMI >=25 kg /m² *Sedentary and able to practice physical exercise * Stable Weight for the last 6 months * Agree to eat meals during given times of the day
Exclusion criteria
Exclusion criteria: * 6 months before the study: Taking any type of antioxidant substances, vitamins or anti-inflammatory drugs. * No hormonal treatments or sleeping pills (hypnotics and anxiolytics) two weeks before the study * Patients who have undergone a rehabilitation protocol * Smoking, alcoholism, drugs * Other chronic or autoimmune neurodegenerative comorbidities. * Diabetes, osteoporosis, other neurological, vestibular, cognitive, orthopedic, and psychiatric disorders. *Any contraindication to the practice of a physical activity (serious cardiovascular or pulmonary diseases). * Pregnant or lactating women in the last six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1- Body composition (weight, Body Fat Mass, Lean mass, Bone Mass, Muscle mass and Body Water) will be measured throw impedancemetr . 2- Cardio-respiraotry capacity will be measured during 6 minutes walking test with using spirometry one time: pre intervention.Systolic blood pressure and diastolic blood pressure using blood pressure monitor. 3- Change in Physical parameters : static and dynamic balance measurements will be performed throw Y balance test with both legs (write and left.) Aerobic capacity and respiratory volumes will be measured using 6 minutes walking test and spirometry. Pulsed" oxygen saturation using Pulse oximeter - SpO2 saturometer. The abalakov jump test will be used to measure leg power.Maximum muscle strength will be determined using a maximum repetition test (1RM), women will attempt to familiarize themselves with each of the resistance machines (leg press) (weight bench with loaded bars) by performing 8-10 reps of a light load (~50% of expected 1RM), followed by (80 % of estimated 1RM). After each successful performance, the weight would increase until an unsuccessful attempt occurred. 4- Change in biochemical parameters: change in lipid profile(i.e. Total Cholesterol (TC), High-density lipoprotein (HDL), Lowdensity lipoprotein (LDL) and Triglycerides (TG)) will be measured enzymatically. Change in hepatic profile : dosage of transaminases, alkaline phosphatase, gamma glutamyl transpeptidase and bilirubin. Change in thyroidien profile: FT4 and TSH CRP will be measured with Latex particle immunoturbidimetric test. Change in hormones:Cortisol and Insulin concentrations Change in Glucose metabolism included fasting glycemia, and HOMA-IR levels | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Change in eating behavior parameters will be measured using differents Questionnaires ( TFEQ : Three factor eating Questionnaire, EDE-Q : Eating disorders diagnosis and EDRSQ-F : Eating disorder.) 2- change in cognitive function will be assessed using the Mini Mental State (MMSE) and Barrage numbers tests which assesses different cognitive domains: attention and concentration, executive functions, memory, language, Visuoconstructional skills, conceptual thinking, calculations and orientation, 3- Change in Psychological parameters will be measured using SEPOB questionnaire that assesses the feeling of self-efficacy specific to obesity. 4- change in sleep quality will be evaluated using Sleep Diary * Epworth sleepiness scale: include eight questions, and its total score varies between 0 and 10 and whose score equal to or more 10 corresponds to sleep disorders. * Actimetry. 5- Change in Quality of life will be evaluated by The Short Form Health Survey (SF36) which includes 36 items divided into 8 dimensions (physical activity, life and relationships with others, physical pain, perceived health, vitality, limitations due to mental state, limitations due to physical condition and mental health) 6-Physiological response: change in Cardiac variability, resting heart rate will be assessed using (Polar V 800). | — |
Countries
Tunisia
Contacts
The Research Unit of ISSEPS sfax; The Research Unit of Isseps Sfax