Effects of a Physical Exercise Program Adapted to People With Obesity on Health Indicators and Quality of Life.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in body composition
研究概览
简要总结
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?
详细描述
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.:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants do not know if they have metabolic syndrom Physical training supervisors do not know if participants have metabolic syndrom
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in body composition
时间窗: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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
Change in physical fitness (aerobic power; VO2max)
时间窗: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min)
Change in physical fitness (Coordination; balance)
时间窗: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Balance test one leg (seconds)
Change in low-grade chronic inflammation
时间窗: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Plasma levels of inflammatory and lipoinflammatory markers Multiplex Quantitative measurement of 40 human adipokines in plasma (cytokine antibody arrays (pg/ml) : 1. Adiponectin 2. Adipsin 3. AgRP 4. ANGPTL4 5. BDNF 6. Chemerin 7. CRP 8. GH 9. IFNg 10. IGFBP-1 11. IGFBP-2 12. IGF-I 13. IL-10 14. IL-12p40 15. IL-12p70 16. IL-1b 17. IL-1ra 18. IL-6 19. IL-8 20. Insulin 21. Leptin 22. Lipocalin-2 23. MSPa 24. OPG 25. PAI-1 26. PDGF-BB 27. Pepsinogen 1 28. Pepsinogen 2 29. Procalcitonin 30. Prolactin 31. RANTES 32. RBP4 33. Resistin 34. SAA 35. TGFb1 36. TSP-1 37. TNF RI 38. TNF RII 39. TNFa 40. VEGF
Change in physical fitness (resistance; muscular strength)
时间窗: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
* Maximum dynamic strength of the upper body (bench press; kg) * Lower body maximal dynamic strength (leg press; kg) * Grip maximal isometric strength (handgrip: kg)
Change in perceived health and perceived quality of life
时间窗: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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.
Change in healthy eating habits
时间窗: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
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.
次要结局
- Change in Biochemistry Determinations In Plasma (protein metabolism)(From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle))
- Change eating habits(Every week, from baseline (0 weeks) to follow-up (10 weeks))
- Change in Biochemistry Determinations In Plasma (lipidic profile)(From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle))
- Change in Biochemistry Determinations In Plasma (glucose metabolism)(From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle))
- Change in Biochemistry Determinations In Plasma (Enzymes of fatigue or muscular damage)(From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle))
研究者
José Antonio González Jurado
PhD
Universidad Pablo de Olavide