Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-28 @ 3:45 AM
Study NCT ID:
NCT05713461
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2023-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Exercise in Obesity for Health and Quality of Life.
Sponsor:
Universidad Pablo de Olavide
Organization:
Study Overview
Official Title:
Effects of a Physical Exercise Program Adapted to People With Obesity on Health Indicators and Quality of Life.
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBEFYSA
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?
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: