Physical Exercise in Obesity for Health and Quality of Life.

Obesity Clinical Trial

— OBEFYSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05713461
• Other study ID #: UPO-1381609
• Status: Completed
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Universidad Pablo de Olavide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Overweight or Obesity

Intervention

Behavioral:
• exercise training program
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
• 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.

Locations

Country	Name	City	State
Spain	CIRFD Universidad Pablo de Olavide	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Pablo de Olavide	University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)