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Recruiting NCT05713461

Physical Exercise in Obesity for Health and Quality of Life.

Conditions: Obesity, Overweight and Obesity, Overweight or Obesity

Sex: Female
Ages: 35 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: Universidad Pablo de Olavide

Location: Spain

Summary

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?

Eligibility Criteria

Inclusion Criteria:The recruitment of participants would be carried out through advertising in the press, social networks, and electronic media.Main inclusion criteriaSex: FemaleCaucasianAge. women from 35 years to 65 years.BMI: >29Abdominal perimeter: >90 cm womenNo known DiabetesNo known cancerNo Known lung diseaseNo known cardiovascular diseaseNo known thyroid diseaseNo known liver diseaseNo known autoimmune diseaseNo other endocrine disorder causes obesityNo current treatment with anti-obesity medicationNo current treatment with anti-inflammatory medicationNo weight loss of > 5kg within the last 6 monthsNo diagnosis of depression or treatment with anti-depressive medication, ongoing or within the last three months before enrolmentNo diagnosis of psychiatric disorder or treatment with antipsychotic medicationNo history of suicidal behavior or ideations within the last three months before enrolmentNo previous surgical treatment for obesityNot pregnant/considering pregnancyNo functional impairments that prevent the performance of intensive exerciseDeclare a sedentary lifestyle ((< 1,5 hours of structured physical activity per week at moderate intensity)No participation in other research intervention studiesSigned informed consent.Exclusion Criteria:Diagnosis of pathology that involves an inflammatory process in the last year.Objective findings that contraindicate participation in intensive exerciseThe language barrier, mental incapacity, unwillingness or inability to understand the instruction of the studyNot completing 75% of the training sessions

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05713461). StuddyBuddy aggregates publicly available trial information.