Functional Assessment and Pulmonary Rehabilitation: Challenges and Perspectives for Comprehensive Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Diaphragmatic Excursion (DE)
研究概览
简要总结
Individuals with Chronic Obstructive Pulmonary Disease (COPD) present with respiratory muscle dysfunction, characterized by reduced diaphragmatic contractility and mobility due to pulmonary hyperinflation, oxidative stress, and systemic inflammation. Effective assessment of diaphragmatic function is crucial for monitoring progress in pulmonary rehabilitation programs. This study aims to evaluate diaphragmatic function and mobility in COPD patients undergoing pulmonary rehabilitation with inspiratory muscle training, using ultrasound, and to identify associations between diaphragmatic dysfunction and clinical symptoms such as dyspnea and fatigue. A randomized clinical trial will be conducted to investigate the impact of rehabilitation on diaphragmatic function, correlating it with pulmonary function and physical performance.
详细描述
This study aims to evaluate diaphragmatic muscle function and mobility through ultrasonography in individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD) undergoing a pulmonary rehabilitation program combined with inspiratory muscle training (IMT). The research will investigate the relationship between diaphragmatic behavior, clinical severity, and the repercussions on respiratory capacity.
Upon meeting the inclusion criteria, participants will undergo an initial clinical and sociodemographic assessment, including medical history, spirometry, manovacuometry, and the 6-Minute Walk Test (6MWT). Symptom impact and dyspnea will be measured using the COPD Assessment Test (CAT) and the mMRC scale. Participants will then be allocated into two groups:
IMT Group (IMTG): Participants will perform IMT using the PowerBreathe Classic (3 sets of 10 reps; load increasing from 50% to 60% of MIP), followed by resistance training (60-70% of 1RM) and aerobic training (20 minutes on a stationary bike at 60-80% intensity based on the Karvonen Formula and Borg Scale 4-6).
Control Group (CG): Participants will undergo the exact same resistance and aerobic training protocols as the IMTG. However, they will perform a Sham IMT using the device at its minimum load setting (3 sets of 10 reps) to maintain the same training volume and procedural consistency without the threshold training effect.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older.
- •Both sexes are eligible (men and women).
- •Clinically diagnosed COPD, clinically stable, classified in Stages I, II, III or IV of GOLD (Global Initiative for Chronic Obstructive Lung Disease).
- •Ability to understand and provide the signed Informed Consent Form to participate in the study.
排除标准
- •Physical limitations and/or cognitive impairment that prevent the execution of the study protocol.
- •Currently engaged in physical therapy treatment and/or physical activity that may interfere with the study results.
- •Presence of severe, uncontrolled, or disabling comorbidities.
研究组 & 干预措施
TMI Group (GT)
Participants in this arm will undergo an intervention consisting of resistance and aerobic exercises, combined with inspiratory muscle training. The protocol will be conducted over 7 weeks, comprising 20 sessions performed 3 times per week.
干预措施: Pulmonary rehabilitation combined with inspiratory muscle training (Device)
Control Group (CG)
Participants in this arm will undergo an intervention consisting of resistance and aerobic exercises, combined with sham inspiratory muscle training (IMT). The sham IMT protocol will utilize only the minimum load of the device. The protocol will be conducted over 7 weeks, comprising 20 sessions performed 3 times per week.
干预措施: Pulmonary rehabilitation with placebo inspiratory muscle training (Device)
结局指标
主要结局
Diaphragmatic Excursion (DE)
时间窗: Baseline and after 7 weeks.
Diaphragmatic excursion will be assessed by visualizing the right hemidiaphragm via an anterior subcostal approach between the midclavicular and anterior axillary lines, using a convex transducer in M-mode, with results expressed in millimeters (mm).
次要结局
- Diaphragmatic Thickness (Tdi)(Baseline and after 7 weeks.)
- Diaphragmatic Thickening Fraction (DTF)(Baseline and after 7 weeks.)
- Lung Function Parameters (Spirometry)(Baseline and after 7 weeks.)
- Respiratory Muscle Strength (MIP and MEP)(Baseline and after 7 weeks.)
- COPD Assessment Test (CAT) Score(Baseline and after 7 weeks)
- Medical Research Council (MRC) Dyspnea Scale(Baseline and after 7 weeks of intervention.)
- Functional Capacity (6-Minute Walk Test - 6MWT)(Baseline and after 7 weeks.)
研究者
Gleidiane Lorrana Sales Dos Santos
Master's Student
Universidade do Estado do Pará