Effect of Respiratory Training Protocols on GH Secretion in the Obese Patient
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Insulin-like growth factor (IGF-I)
研究概览
简要总结
The study's primary objective is to evaluate the acute and chronic (3 weeks) effects of two respiratory training protocols in obese adolescents (performed during a period of hospitalization for a body weight reduction program), with different characteristics and mechanisms of action, on GH and IGF-I secretion. The definition of the protocols is based on what has been observed by recent studies conducted on healthy people (Wuthrich et al., 2015; Schaer et al., 2018) and on patient populations in which respiratory dysfunction is a primary or secondary component of the pathology (Calcaterra et al., 2014; Pomidori et al., 2009). All planned interventions are safe and are adapted to the obese patient.
Project objectives are:
- assessment of GH-IGF-I responses (baseline), during the first training session of the respiratory muscles conducted in the first days of hospitalization of the patients in the clinic
- assessment of GH-IGF-I responses (post), during the last training session of the respiratory muscles conducted at the end of the three weeks of each training session
详细描述
Materials and methods:
Subjects The study provides for the recruitment of 20 obese boys/young adults aged between 14 and 30 years old hospitalized at the Division of Auxology and the Division of Metabolic Diseases, Istituto Auxologico Italiano, S. Giuseppe Hospital, Piancavallo (VB).
Criteria for inclusion in the study group are:
- BMI standard deviation score (SDS)>2 for patients < 18 years and BMI>35 for patients aged>18 years;
- absence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
Materials and methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •BMI standard deviation score (SDS) > 2 for subjects aged < 18 years and BMI > 35 for patients aged >18 years;
- •absence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- •absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
排除标准
- •age < 14 years and > 30 years;
- •presence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
- •presence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.
结局指标
主要结局
Insulin-like growth factor (IGF-I)
时间窗: Baseline and 0 minutes after Intervention
Change in plasma concentration of insulin-like growth factor
Growth hormone (GH)
时间窗: Baseline, 0, 15, 30 and 45 minutes after Intervention and 3 weeks after intervention
Change in plasma concentration of growth hormone
次要结局
未报告次要终点