Acute Effects of Inspiratory Muscle Training With Different Loads on Peripheral Muscle Metabolism and Autonomic Response in COPD Patients: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peripheral vascular function and muscle metabolism
研究概览
简要总结
The study will evaluate the acute effects of inspiratory muscle training (IMT) on peripheral muscle metabolism and autonomic response in patients with chronic obstructive pulmonary disease (COPD). This is a randomized, crossover study, with blinding of the evaluator and the researcher responsible for the statistical analysis. Participants will be divided into three groups at different times: TMI- strength (F), TMI to gain inspiratory muscle strength; IMT- resistance (R), IMT for improving inspiratory muscle resistance; and TMI sham. All participants randomized in the study will participate in the three groups, with a minimum interval of 48 hours between participation in each group. Randomization will determine the sequence of participation in the three groups for all participants.
For statistical analysis, an intention-to-treat approach will be used, and the groups will be compared using the Student's t test for continuous variables or the chi-square test for categorical variables. A split-plot ANOVA with repeated measures will be used for primary outcomes, and analysis of covariance will be conducted to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared.
It is expected that IMT applied at different loads can promote effects on vascular function, peripheral muscle metabolism and the response of the autonomic nervous system in patients with COPD, which can greatly contribute to the understanding of the physiological effects of this therapy and support its prescription. as a therapeutic intervention in the rehabilitation of patients with pulmonary diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Blinding of the evaluator and the researcher responsible for statistical analysis.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COPD according to the Global Initiative for COPD (GOLD, 2023);
- •Aged 40 years or older and under 75 years;
- •Providing both oral and written informed consent.
排除标准
- •Inability to perform the IMT protocol and/or functional tests;
- •Presence of psychiatric disorders or cognitive impairments, progressive neurological disorders, cancer, or chronic pain;
- •Cognitive impairment or inability to understand commands.
- •Patients who have experienced any health issue or had a COPD exacerbation in the previous month will also be excluded to ensure that the patient's symptoms are stable.
研究组 & 干预措施
IMT-S (strength)
Will be individualized according to the MIP achieved in the initial assessment of each patient's inspiratory muscle strength, with the load being equivalent to 60% of the MIP in cmH2O.
干预措施: IMT-S (strength) (Other)
IMT-R (resistance)
Three sets of two minutes of maximum, deep inspirations followed by two minutes of rest between them, totaling six minutes of IMT. The initial load of the equipment for the IMT-R group will also be individualized, equivalent to 30% of the MIP in cmH2O.
干预措施: IMT-R (resistance) (Other)
Sham
Three sets of two minutes of maximum, deep inspirations followed by two minutes of rest between them, totaling six minutes of IMT with a minimum load of 3cmH2O.
干预措施: Sham - IMT (Other)
结局指标
主要结局
Peripheral vascular function and muscle metabolism
时间窗: Up to four weeks
Evaluated using Near Infrared Spectroscopy (NIRS). Tissue perfusion measurement will be performed using an arterial occlusion maneuver. After three minutes of rest to stabilize the initial measurements; \[tissue oxygen saturation (StO2) measured in percentage (%), oxyhemoglobin (HbO2) and deoxyhemoglobin (HHb) measured in mmHg\], the cuff will be inflated above 250 mmHg up to 280 mmHg , so that the blood flow is completely interrupted, being maintained for a period of five minutes, until the stabilization of the measurements. The variables obtained during the arterial occlusion maneuver will be: StO2 recovery time after occlusion, HHb variation during occlusion and StO2 variation during occlusion. The variables obtained during the exercise will be: variation of HHb and StO2, time to reach the lowest StO2, rate of deoxygenation and reoxygenation and walking economy in relation to HHb and StO2.
Heart rate and R-R interval recordings
时间窗: Up to four weeks
Patients will be evaluated in the laboratory at 22 degrees Celsius (°C) with relative humidity between 50-60%. They should avoid stimulants, alcohol and exercise the day before the test and refrain from smoking or using bronchodilators for 6 hours before the test. An electrocardiogram will be recorded via Holter (CARDIOS™, Brazil) using a bipolar DII electrode, with three electrodes placed on the chest after asepsis and trichotomy. Holter software will provide time series data of heart intervals, analyzing heart rate variability (HRV) in both the time and frequency domains. In the time domain, indicators of sympathetic and parasympathetic activity will be calculated. In the frequency domain, the low, high and very low frequency bands will be evaluated, with the ratio between low frequency and high frequency, representing sympathovagal balance.
次要结局
- Subjective perception of effort(Up to four weeks)
- Lung function(Up to four weeks)
- Respiratory muscle function(Up to four weeks)
- Thickness and thickening fraction and diaphragmatic mobility(Up to four weeks)
- Echointensity and thickness of the quadriceps femoris(Up to four weeks)
- Feeling of dyspnea(Up to four weeks)
- Functional capacity(Up to four weeks)
研究者
Eduardo Eriko Tenório de França
Clinical Professor
Federal University of Paraíba