Effects of Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Static postural balance
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a significant current public health problem, characterized by the presence of limited airflow. However, COPD has important manifestations beyond the lungs, the so-called systemic effects. These included dysfunction of peripheral and respiratory muscles. The growing amount of evidence has shown that patients with COPD also present important deficits in postural balance and consequently, increased risk of falling. As an essential part of the management of COPD, pulmonary rehabilitation (PR) alleviates dyspnea and fatigue, improves exercise tolerance and health-related quality of life, and reduces hospital admissions and mortality for COPD patients. Exercise is the key component of PR, which is composed of exercise assessment and training therapy. Currently, two modalities of therapy have been suggested as complementary to pulmonary rehabilitation: inspiratory muscular training (IMT) and neuromuscular electrical stimulation (NMES). Based on the premise that peripheral and respiratory muscle dysfunction can negatively impact postural control of patients with COPD, and given the importance of balance as a modifiable risk factor for falls, it is important to investigate whether the use of these therapeutic modalities (IMT and/or NMES) is capable of improving the short-term effects of pulmonary rehabilitation and also promoting improved balance.
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)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD, in stages II, III and IV, according to criteria of the Global Initiative for COPD (GOLD);
- •Clinically stable, i.e., absence of infections or exacerbations in the last 3 months;
- •Medical team allows patient to exercise
- •Availability of attending the rehabilitation program.
排除标准
- •Unstable primary pathologies (cardiovascular, renal, metabolic, psychiatric);
- •Hemodynamic instability;
- •Nutritional supplementation on the 4 weeks preceding the study;
- •Severe hearing or visual impairment recorded on patient chart or self-referred;
- •Obesity (BMI > 30 kg/m2);
- •Neurological or musculoskeletal condition that severely limits mobility and postural control, thus making it impossible to carry out the assessments;
- •Electronic devices, such as heart pacemakers and implantable cardioverter defibrillator;
- •Skin injuries and infection where electrodes would be placed;
- •Prior participation in pulmonary rehabilitation programs 3 months previous to the study;
- •Active smoker and/or alcoholic;
- •Neurological impairment or cerebellar lesions;
- •Deficit in cognitive function;
- •Severe vitamin D deficiency;
- •Physically active.
结局指标
主要结局
Static postural balance
时间窗: Post-intervention (change after 8 weeks of training)
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of pressure displacement amplitude in the anteroposterior direction (COP) (cm).
次要结局
- Quadriceps femoris and diaphragm thickness(Post-intervention (change after 8 weeks of training))
- Health-related quality of life at 8 week(Post-intervention (change after 8 weeks of training))
- Antioxidant profile(Post-intervention (change after 8 weeks of training))
- Static postural balance(Post-intervention (change after 8 weeks of training))
- Dynamic postural balance(Post-intervention (change after 8 weeks of training))
- Peripheral muscle strength(Post-intervention (change after 8 weeks of training))
- Respiratory muscle strength and inspiratory muscle endurance(Post-intervention (change after 8 weeks of training))
- Submaximal level of functional capacity(Post-intervention (change after 8 weeks of training))
- DNA damage(Post-intervention (change after 8 weeks of training))
- Endothelial function(Post-intervention (change after 8 weeks of training))
- Peripheral muscle resistance of the lower limbs(Post-intervention (change after 8 weeks of training))
- Static and dynamic postural balance(Post-intervention (change after 8 weeks of training))
- Balance confidence questionnaire(Post-intervention (change after 8 weeks of training))
- Oxidant profile(Post-intervention (change after 8 weeks of training))
- Muscle damage(Post-intervention (change after 8 weeks of training))
研究者
Isabella Martins de Albuquerque
Principal Investigator
Universidade Federal de Santa Maria