Inspiratory Muscle Rehabilitation in Children With Obesity to Promote Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Number of Participants Who Complete Study Visit 3
研究概览
简要总结
This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked, interventional trial among children aged 8-17 years (not yet 18 years old) of age with obesity (n=30), recruited from the Duke Healthy Lifestyles Clinic to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity
详细描述
Improved management of obesity is an urgent public health need. Nearly 40% of US children and adolescents have a body mass index that markedly increases their risk for serious metabolic and cardiopulmonary sequelae. Current childhood obesity rates, for the first time in US history, predict a decline in life US expectancy. Importantly, childhood obesity is a key driver of health disparities in the US, with obesity disproportionately affecting African-American, Hispanic-Latino, and Native American children. A key contributor to the sequelae of obesity is sedentariness. Thus, best practice in obesity management includes both reducing sedentariness and establishing durable increases in daily physical activity, however, attrition from planned exercise programs remains high. A key challenge to initiating and sustaining physical activity in children with obesity is the extreme dyspnea (breathlessness) they experience. This is due to the altered thoracic mechanics of obesity which lead to enhanced inspiratory muscle fatigue and dyspnea, with even modest physical activity. Our group has confirmed that among adolescents, higher body mass index (BMI) associates with lower inspiratory muscle endurance (r= -0.680, p=0.049, n=14), and that this lower endurance correlates with more frequent dyspnea (r= - 0.672, p=0.023, n=12). Treating obesity-related inspiratory muscle impairment and dyspnea is a promising approach to support physical activity in children with obesity but is yet unproven.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The only person who will know the arm of each participant will be the study team member in charge of randomization (the clinical research coordinator)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented informed consent from legal guardian and assent from participant as appropriate.
- •Children 8 to 17 years of age with obesity (BMI ≥ 95th percentile for age and sex) being seen at Duke Healthy Lifestyles clinic.
- •Participants (or parent/guardian) must have access to the internet and an approved smart device/computer.
- •Child must have a designated caregiver who expresses a commitment to encourage the participant to complete the study procedures.
- •Participant and legal guardian must speak and read English.
排除标准
- •Prior enrollment in an IMR program.
- •Contraindications for IMR including a history of recent lung surgery, recent pulmonary embolism, or history of recurrent spontaneous pneumothorax
- •Progressive neurological or neuromuscular disorders or need for chronic O2 therapy.
- •Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI.
- •Current self-reported pregnancy or planning to become pregnant.
- •Body weight greater than 300 pounds.
- •Any condition in the opinion of the PI that would not allow safe conduct of study procedures (including IMR, MIP testing or step-test), such as a physical disability, recent musculoskeletal injury or illness, current and ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms, undiagnosed chest pain, pneumothorax in the past 12 months, inner ear surgery in the past 12 months, or undiagnosed syncopal episodes.
结局指标
主要结局
Number of Participants Who Complete Study Visit 3
时间窗: approximately 2 months
Adherence to Active IMR (Inspiratory Muscle Rehabilitation)
时间窗: up to 2 months
Percentage of IMR completion (actual / planned reps over intervention period x 100)
Participant Satisfaction With IMR (Inspiratory Muscle Rehabilitation)
时间窗: up to 2 months
Scored on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree.
次要结局
- Change in Average Daily Sedentary Physical Activity (SPA) Time(Baseline, approximately 2 months)
- Change in Average Daily Moderate-vigorous Physical Activity (MVPA) Time(Baseline, approximately 2 months)
- Change in Maximum Inspiratory Pressure (MIP) Over Intervention Period(Baseline, approximately 2 months)
- Change in Modified Medical Research Council (mMRC) Dyspnea Scores Over Intervention Period(Baseline, approximately 2 months)
- Change in Average Daily Step Count(Baseline, approximately 2 months)