High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea: Study Protocol for a Prospective Nonconcurrent Multiple-Baseline Single-Case Experimental Design With Stability-Based Phase Transition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and effects of a 12-week high-intensity progressive Inspiratory Muscle Training (IMT) program in individuals with Class III obesity (BMI ≥ 40 kg/m²) and obstructive sleep apnea (OSA). Using a single-case experimental design (SCED) with multiple baselines, the study will investigate whether this respiratory intervention can reduce the severity of sleep apnea, as measured by the Apnea-Hypopnea Index (AHI), and improve inspiratory muscle strength and sleep quality. Participants will perform daily training sessions using a resistive loading device (POWERbreathe), with intensity progressing from 40% to 90% of their maximum inspiratory pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years).
- •Of both genders.
- •Class III obesity (BMI > 40 kg/m²).
- •Diagnosis of OSA.
- •Without neurological conditions that would prevent them from responding to the study assessments.
排除标准
- •Systemic diseases (pulmonary, cardiac or renal).
- •Are using medications that may affect muscle performance.
- •Are currently using CPAP therapy.
- •Conditions that could compromise adherence to the study protocol.
研究组 & 干预措施
Experimental Group: High-Intensity IMT
Participants will undergo a progressive high-intensity Inspiratory Muscle Training (IMT) program using a resistive loading device (POWERbreathe).
干预措施: High-Intensity Progressive Inspiratory Muscle Training (IMT) (Device)
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: Baseline (Phase A - three measurements) and Post-Intervention (Phase B - 12th week).
Number of apnea and hypopnea events per hour of sleep, measured via portable polygraphy (Type III)
次要结局
- Maximum Inspiratory Pressure (MIP)(Weekly assessments throughout Phase A (3 to 5 weeks) and Phase B (12 weeks).)
- Epworth Sleepiness Scale (ESS) score(Baseline and Post-Intervention (12th week).)
- Pittsburgh Sleep Quality Index (PSQI) global score(Baseline and Post-Intervention (12th week).)
- International Physical Activity Questionnaire (IPAQ) - Short Form(Baseline and Post-Intervention (12th week).)
- Borg Rating of Perceived Exertion (RPE)(Daily during the 12 weeks of intervention (Phase B).)
- Quebec Sleep Questionnaire (QSQ)(Baseline (Phase A) and Post-Intervention (12th week of Phase B).)
研究者
Karina Abreu
Principal Investigator
University of the State of Santa Catarina