Clinical trial NCT05713461: Physical Exercise in Obesity for Health and Quality of Life.
Official title: Effects of a Physical Exercise Program Adapted to People With Obesity on Health Indicators and Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight and Obesity
Overweight or Obesity
Keywords: lipoinflammation
metabolic syndrome
training
overweight
sedentary lifestyle
Lead sponsor: Universidad Pablo de Olavide
Sponsor class: OTHER
Collaborators: name: University of Seville
First posted: 2023-02-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: To compare the effects of an interval training program in obese women with metabolic syndrom vs obese women without metabolic syndrom
Primary purpose: TREATMENT

Brief 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?

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in low-grade chronic inflammation
timeFrame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in body composition
timeFrame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in physical fitness (resistance; muscular strength)
timeFrame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in physical fitness (aerobic power; VO2max)
timeFrame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in physical fitness (Coordination; balance)
timeFrame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in perceived health and perceived quality of life
timeFrame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in healthy eating habits
timeFrame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Secondary outcomes:
measure: Change eating habits
timeFrame: Every week, from baseline (0 weeks) to follow-up (10 weeks)
measure: Change in Biochemistry Determinations In Plasma (lipidic profile)
timeFrame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in Biochemistry Determinations In Plasma (glucose metabolism)
timeFrame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in Biochemistry Determinations In Plasma (Enzymes of fatigue or muscular damage)
timeFrame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
measure: Change in Biochemistry Determinations In Plasma (protein metabolism)
timeFrame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: CIRFD Universidad Pablo de Olavide
Study officials:
affiliation: Universidad Pablo de Olavide de Sevilla
name: Jose A Gonzalez-Jurado, PhD
role: PRINCIPAL_INVESTIGATOR
References: