Inflammatory and Metabolic Outcomes After Obese Woman Performed High Intensity Interval Training

Study Overview
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Brief Summary
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The main purpose of this study is to compare the effects of high intensity interval training and moderate intensity continuous training on inflammatory profile and metabolic markers, after 8 weeks of intervention trial in obese women.

Official Title
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Inflammatory and Metabolic Outcomes in Obese Women After 8 Weeks of High Intensity Interval Training and Moderate Intensity Continuous Training: a Randomized Controlled Pilot Study

Conditions
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Obesity and Metabolic Syndrome

Intervention / Treatment
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* Other: CTR
* Other: MICT
* Other: HIIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index between (30-40 kg/m²) age between 25 and 41 years to be sedentary Exclusion Criteria: type 1 or type 2 diabetes Hypertension pregnancy, Lactation having undergone bariatric surgery psychological disorders, epilepsy, sever neurological disorders participation in other moderate, vigorous exercise or nutrition intervention acute or chronic cardiovascular disease malignant disease kidney disease lung disease hyperthyroidism or hypothyroidism smoking any type of cigarette joint limitations electronic implants (defibrillator, pacemaker)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three-arm parallel, Randomized-controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group (CTr)<br>No counseling or nutritional therapy and no exercise | Other: CTR<br>* no counseling or nutritional therapy and no exercise<br>|
| Experimental: Moderate intensity continuous training (MICT)<br>Follow-up during a period of 8 weeks of supervised ergometer-based moderate-intensity continuous training based on HRmax (MICT). MICT: 3 sessions per week intensity at 65-75% HRmax time-effort per session: 50 min | Other: MICT<br>* no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).<br>|
| Experimental: High Intensity Interval Training (HIIT)<br>Procedures: Follow-up during a period of 8 weeks of supervised ergometer-based high intensity interval training based on HRmax (HIIT). HIIT: 3 sessions per week 10 bouts of one minute at 90% HRmax interspersed by one minute at 40% HRmax time-effort per session: 25 min | Other: HIIT<br>* no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory profile | C-reactive protein (CRP) (mg/dL) | 8 weeks (baseline to 8 week follow-up assessment) | 
| Inflammatory profile | Interleukin 6 (IL-6) (ng/mL) | 8 weeks (baseline to 8 week follow-up assessment) | 
| Inflammatory profile | Interleukin 10 (IL-10) pg/mL, Interleukin-1B (IL-1B) pg/mL, Tumor Necrosis Factor (TNF)-α (pg/mL), Adiponectin (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL), Leptin (pg/mL) | 8 weeks (baseline to 8 week follow-up assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition and Anthropometric profile | Body weight (kg), Fat free mass (FFM) (kg), fat mass (FM) (kg) | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Body Composition and Anthropometric profile | Body Mass Index (BMI) (kg/m²) | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Body Composition and Anthropometric profile | Waist circumference (cm), hip circumference (cm) | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Body Composition and Anthropometric profile | Body Adiposity Index (BAI) and Waist-To-Hip Ratio (WHR) | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Insulin sensitivity | Insulin sensitivity was estimated using homeostasis model assessment index (HOMA) | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Lipid profile | Lipid profile was assessed by measuring levels of triglyceride (TG) (mg/dL), total cholesterol (CT) (mg/dL), high-density lipoprotein cholesterol (HDL-C) (mg/dL) and low-density lipoprotein cholesterol (LDL-C) (mg/dL) | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Cardiorespiratory Fitness (CRF) | CRF was assessed by measuring Peak Oxygen uptake (VO2peak) mL/kg/min | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Blood Pressure (BP) | Blood Pressure (mmHg) was assessed by measuring rest levels of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Resting Energy Expenditure (REE) | Resting Energy Expenditure (kcal/day) was measured through indirect calorimetry with an open-circuit ventilated-hood system Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min) | 8 weeks (baseline to 8 week follow-up assessment) ] | 
| Substrate oxidation rate | Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min) | 8 weeks (baseline to 8 week follow-up assessment) ] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High intensity interval training, Inflammation, Obesity, adipokines