Physical Exercise in Obesity for Health and Quality of Life.

Study Overview
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Brief Summary
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This project aims to develop an intervention on healthy habits based on physical exercise and nutritional education in people with obesity. It is accepted that exercise and nutrition are keys to controlling body weight. People with obesity frequently present with metabolic syndrome and a low-grade inflammatory state. It is not known what should be the most effective training load/dose (duration, intensity, type of exercise) to improve health indicators related to metabolic syndrome and lipo-inflammation, and body composition in people with obesity. A large-scale randomized controlled trial (RCT) will be essential to better understand the type and characteristics of training load/dose most effective in counteracting the detrimental effects of obesity. The aim of this trial in 50 obese women was to answer the following questions: Does the training program improve physical fitness? Does the training program improve body composition? Does the training program improve the state of chronic low-grade inflammation? Does the training program improve the quality of life and perceived health? Do people with obesity and metabolic syndrome respond in the same way to training? what is the effect of four weeks of detraining?

Detailed Description
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A female single group, 2-armed ( people with obesity and metabolic syndrome vs people with obesity without metabolic syndrome), investigator-blinded, trial. The study will last 17 weeks. Week 1 (testing 1: pretest); weeks 2-11 (Intervention: interval training program); week 12 (testing 3: postest); weeks 13-16 (detraining period); week 17 (testing 3: detraining test) Participants will be allocated (1:1) regarding metabolic syndrome Behavioural: exercise training program Adapted Interval Training Intervention, three days a week, 10 weeks. Warm-up ≃ 10': Joint mobility and cardiovascular activation. Main part ≃ 45 min.: Resistance training circuit for strengthening the main muscle groups. Shoulder muscles Pectoral muscles Knee Flexor-extensor muscles hip flexor extensor muscles Between 50-70% 1 RM (estimated). Repetitions 1-2 RIR (Repetition in Reserve). Load Intensity was controlled through RPE (OMNI-RES Scale) between 7-8 out of 10. The training load will increase while maintaining the same intensity. Cool down ≃ 5' Flexibility and CORE Behavioural: Feeding training Two workshops on healthy eating habits (Week 1 and week 5). Food Frequency Questionnaires (weekly). Feedback weekly Mediterranean Diet Adherence Screener (MEDAS) The dietary intervention will be based on the nutritional recommendations based on the Mediterranean diet, according to the evidence from the PREDIMED trial.

Official Title
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Effects of a Physical Exercise Program Adapted to People With Obesity on Health Indicators and Quality of Life.

Conditions
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Obesity, Overweight and Obesity, Overweight or Obesity

Intervention / Treatment
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* Behavioral: exercise training program
* Behavioral: Feeding training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The recruitment of participants would be carried out through advertising in the press, social networks, and electronic media. Main inclusion criteria Sex: Female Caucasian Age. women from 35 years to 65 years. BMI: >29 Abdominal perimeter: >90 cm women No known Diabetes No known cancer No Known lung disease No known cardiovascular disease No known thyroid disease No known liver disease No known autoimmune disease No other endocrine disorder causes obesity No current treatment with anti-obesity medication No current treatment with anti-inflammatory medication No weight loss of > 5kg within the last 6 months No diagnosis of depression or treatment with anti-depressive medication, ongoing or within the last three months before enrolment No diagnosis of psychiatric disorder or treatment with antipsychotic medication No history of suicidal behavior or ideations within the last three months before enrolment No previous surgical treatment for obesity Not pregnant/considering pregnancy No functional impairments that prevent the performance of intensive exercise Declare a sedentary lifestyle ((< 1,5 hours of structured physical activity per week at moderate intensity) No participation in other research intervention studies Signed informed consent. Exclusion Criteria: Diagnosis of pathology that involves an inflammatory process in the last year. Objective findings that contraindicate participation in intensive exercise The language barrier, mental incapacity, unwillingness or inability to understand the instruction of the study Not completing 75% of the training sessions

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: To compare the effects of an interval training program in obese women with metabolic syndrom vs obese women without metabolic syndrom
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: obese women without metabolic syndrome<br>Women with obesity and without metabolic syndrome | Behavioral: exercise training program<br>* Adapted Interval Training Intervention, three days a week, 10 weeks. Warm-up 10': Joint mobility and cardiovascular activation Main part: Resistance training circuit for strengthening the main muscle groups. Cool down Flexibility and CORE<br>* Other names: interval training program;Behavioral: Feeding training<br>* Two workshops on healthy eating habits (Week 1 and week 5). Food Frequency Questionnaires (weekly). Feedback weekly. Mediterranean Diet Adherence Screener (MEDAS). The dietary intervention will be based on the nutritional recommendations based on the Mediterranean diet, according to the evidence from the PREDIMED trial.<br>|
| Experimental: obese women with metabolic syndrome<br>Women with obesity and with metabolic syndrome | Behavioral: exercise training program<br>* Adapted Interval Training Intervention, three days a week, 10 weeks. Warm-up 10': Joint mobility and cardiovascular activation Main part: Resistance training circuit for strengthening the main muscle groups. Cool down Flexibility and CORE<br>* Other names: interval training program;Behavioral: Feeding training<br>* Two workshops on healthy eating habits (Week 1 and week 5). Food Frequency Questionnaires (weekly). Feedback weekly. Mediterranean Diet Adherence Screener (MEDAS). The dietary intervention will be based on the nutritional recommendations based on the Mediterranean diet, according to the evidence from the PREDIMED trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in low-grade chronic inflammation | Plasma levels of inflammatory and lipoinflammatory markers Multiplex Quantitative measurement of 40 human adipokines in plasma (cytokine antibody arrays (pg/ml) : Adiponectin Adipsin AgRP ANGPTL4 BDNF Chemerin CRP GH IFNg IGFBP-1 IGFBP-2 IGF-I IL-10 IL-12p40 IL-12p70 IL-1b IL-1ra IL-6 IL-8 Insulin Leptin Lipocalin-2 MSPa OPG PAI-1 PDGF-BB Pepsinogen 1 Pepsinogen 2 Procalcitonin Prolactin RANTES RBP4 Resistin SAA TGFb1 TSP-1 TNF RI TNF RII TNFa VEGF | from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in body composition | Body composition by DEXA. Main body composition components: Body Fat Mass (g) Body Lean Mass (g) Body Bone mineral content (g) Body Total mass (g) Estimated Visceral Adipose Tissue (g) BMI: kg/m^2 | from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in physical fitness (resistance; muscular strength) | Maximum dynamic strength of the upper body (bench press; kg) Lower body maximal dynamic strength (leg press; kg) Grip maximal isometric strength (handgrip: kg) | from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in physical fitness (aerobic power; VO2max) | Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min) | From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in physical fitness (Coordination; balance) | Balance test one leg (seconds) | From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in perceived health and perceived quality of life | perceived health by questionnaire (SF-12). The SF-12 response options are Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item, and each question receives a value that is later transformed into a scale from 0 to 100. | from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in healthy eating habits | Mediterranean Diet Adherence Screener (MEDAS). MEDAS consists of 12 questions on food consumption frequency and 2 questions on food intake habits considered characteristic of the Spanish Mediterranean diet. Each question was scored 0 or 1. | from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change eating habits | Food Frequency Questionnaires (weekly). Recording the frequency of food consumption per week | Every week, from baseline (0 weeks) to follow-up (10 weeks) | 
| Change in Biochemistry Determinations In Plasma (lipidic profile) | LIPIDIC PROFILE Total Cholesterol (mg/dl) HDL Cholesterol (mg/dl) LDL Cholesterol (mg/dl) Triglycerides (mg/dl) | From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in Biochemistry Determinations In Plasma (glucose metabolism) | Glycosylated Hemoglobin A1c (%) Insulin (uU/ml) Glucose (mg/dl) Insulin Resistance. HOMA-IR = (fasting insulin (uU/ml) * fasting glucose (mg/dl)) / 405 | From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in Biochemistry Determinations In Plasma (Enzymes of fatigue or muscular damage) | ENZYMES (Fatigue or muscular damage) Creatine Kinase (UI/L) Transaminases (GOT/AST, GPT/ALT, GGT; UI/L ) C-Reactive Protein (mg/l) | From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 
| Change in Biochemistry Determinations In Plasma (protein metabolism) | PROTEIN METABOLISM Uric Acid (mg/dl) Urea (mg/dl) Creatinine (mg/dl) Bilirubin (mg/dl) | From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipoinflammation, metabolic syndrome, training, overweight, sedentary lifestyle