Precision Exercise Prescription for Obese Children With Bronchial Asthma: a Dose-dependent Study on Adiposity Biomarkers, Body Composition, and Respiratory Efficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Leptin
研究概览
简要总结
This investigation recruited 72 pediatric patients with a confirmed bronchial asthma diagnosis. Participants were randomized into three cohorts: a control group undertaking under 75 minutes of weekly aerobic activity, a low-dose group completing 150 minutes/week, and a high-dose group performing 300 minutes/week. Exercise intensity was maintained between 50-70% of the age- adjusted maximum heart rate across 3-4 supervised sessions per week for a 12-week intervention period.
Pre- and post-intervention analyses included measurements of adipose-tissue- derived adipokines, circulating inflammatory markers, body composition, and pulmonary function parameters.
详细描述
Study Population and Recruitment
A total of 72 pediatric patients with bronchial asthma were enrolled from the Pulmonary Medicine/Critical Care and Allergy-Immunology departments of King Khalid Hospital and two additional tertiary care centers in Riyadh, Saudi Arabia. Eligible participants were children aged 8 to 18 years with a diagnosis of moderate, clinically stable BA and a body mass index ranging from 30.0 to 35.0 kg/m². Further inclusion criteria stipulated the absence of lower limb or spinal deformities, stable medication regimens for the preceding three months, and no participation in structured physical activity for at least six months prior to the study. Exclusion criteria encompassed acute exacerbation of asthma symptoms, the presence of other chronic pulmonary diseases, and any pre- existing cardiovascular or musculoskeletal disorder that could impede exercise training.
Outcome Measures
Adiposity and Inflammatory Biomarkers: Serum concentrations of key adipokines-specifically total adiponectin, high-molecular-weight adiponectin, leptin, and resistin-were analyzed. Concurrently, systemic inflammatory mediators, including interleukin-6 and high-sensitivity C-reactive protein, were quantified using commercially available enzyme-linked immunosorbent assay kits.
Body Composition Analysis: A multi-frequency bioelectrical impedance analysis (BIA) device was employed to determine body composition indices. The parameters assessed included body fat percentage, fat mass, fat-free mass, total body water, and basal metabolic rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A single-blind protocol was adopted. The researcher who collected the data was blind to the allocation of treatment
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 8-18 years
- •Body mass index ranging from 30 to 35 kg/m2
- •Verified asthma diagnosis per the Global Initiative for Asthma (GINA) criteria
- •Moderate Onset
- •Clinically Stable
- •Maintained medication dosages in the past three months
- •Free of lower limb or spinal deformities
- •Not engaging in regular exercise regimens in the past six months.
排除标准
- •Exacerbated asthma symptoms
- •Chronic lung comorbidities
- •Cardiovascular or musculoskeletal conditions expected to hinder the training.
结局指标
主要结局
Leptin
时间窗: 2 months
Serum leptin concentration was evaluated as a primary adipokine. It was assayed using a commercially available enzyme-linked immunosorbent assay kit, with pre- and post-training results expressed in nanograms per milliliter (ng/mL).
Total Adiponectin
时间窗: 2 months
Serum total adiponectin concentration was quantified as a key adiposity biomarker, pre- and post-training. It was measured using a commercially available enzyme-linked immunosorbent assay kit, with results reported in micrograms per milliliter (µg/mL)
High-molecular-weight Adiponectin
时间窗: 2 months
The serum concentration of the high-molecular-weight isoform of adiponectin was analyzed pre- and post-training. It was quantified using a commercial enzyme-linked immunosorbent assay, with levels reported in micrograms per milliliter (µg/mL).
Resistin
时间窗: 2 months
Serum resistin concentration was assessed as an adipokine of interest. Levels were determined from pre- and post-training blood samples using a commercial enzyme-linked immunosorbent assay kit, with concentrations reported in nanograms per milliliter (ng/mL).
Interleukin-6
时间窗: 2 months
Systemic concentration of the inflammatory cytokine interleukin 6 was evaluated. Pre- and post-training levels were quantified using a commercially available enzyme-linked immunosorbent assay kit, with results reported in picograms per milliliter (pg/mL).
High-sensitivity C-reactive protein
时间窗: 2 months
Systemic concentration of high-sensitivity C-reactive protein was assessed as a marker of low-grade inflammation. Pre- and post-training levels were quantified using a commercially available enzyme-linked immunosorbent assay kit, with results reported in milligrams per liter (mg/L).
Body fat percentage
时间窗: 2 months
Body fat percentage was evaluated as a key body composition metric. Pre- and post-training measurements were conducted using a bioelectrical impedance analysis device, with results expressed as a percentage (%).
Fat Mass
时间窗: 2 months
Total body fat mass was assessed as a component of body composition. It was measured pre- and post-intervention using a bioelectrical impedance analysis device, with values reported in kilograms (kg).
Fat-free mass
时间窗: 2 months
Fat-free mass was evaluated as an indicator of lean body tissue. Pre- and post-training measurements were obtained using a bioelectrical impedance analysis device, with results recorded in kilograms (kg).
Total body water
时间窗: 2 months
Total body water was quantified as a fundamental body composition parameter. Pre- and post-training measurements were conducted using a bioelectrical impedance analysis device, with results expressed in liters (L).
Basal Metabolic Rate
时间窗: 2 months
Basal metabolic rate was estimated as a measure of resting energy expenditure. Pre- and post-training assessments were conducted using a bioelectrical impedance analysis device, with results reported in kilocalories per day (kcal/day).
Forced Expiratory Volume in One Second
时间窗: 2 months
Forced expiratory volume in one second (FEV#) was assessed as a primary spirometric parameter of airway function. Pre- and post-training measurements were obtained using a calibrated spirometer, with results expressed as a percentage of the predicted value (% pred) based on established reference standards.
Forced Vital Capacity
时间窗: 2 months
Forced vital capacity (FVC) was evaluated as a key measure of lung volume. Pre- and post-training assessments were performed using a calibrated spirometer, with results expressed as a percentage of the predicted value (% pred).
Forced Expiratory Volume in One Second (FEV1) / Forced Vital Capacity (FVC) Ratio
时间窗: 2 months
The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) was calculated as an indicator of airflow limitation. This derived value was determined from pre- and post-training spirometric maneuvers and is expressed as a ratio (decimal value).
次要结局
未报告次要终点
研究者
Ragab Kamal Elnaggar
Professor
Cairo University