Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients: Protocol for Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Ventilation variability and ventilation efficiency
研究概览
简要总结
Dysfunctional breathing and persistent hypocapnia can be associated with many of the symptoms experienced by patients such as dyspnea, fatigue, chest pain and palpitations. The identification of dysfunctional breathing and hypocapnia in these patients is important as it may represent a target for treatment.
In many of these patients, tachypnea at low levels of exertion suggests increased respiratory muscle activity, which can lead to the sensation of dyspnea. Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise. In this way, inspiratory muscle training can improve symptoms (dysfunctional breathing), possibly by attenuating the metaboreflex (vagal modulation-attenuation of the sympathetic response) of the inspiratory muscle in post-covid-19 subjects, reducing ventilatory variability.
详细描述
Primary objective To evaluate the effects of an unsupervised inspiratory muscle training (IMT) protocol on the behavior of ventilatory variability.
Secondary objective Evaluate the effects of IMT on, respiratory muscle strength, pulmonary function, quality of life, peripheral muscle strength, functional capacity and adverse effects and adherence.
Material and methods Type of study and location of research This randomized, controlled, double-blind, parallel, two arm clinical trial will be conducted at the Laboratory of Health Assessment Measures (LABMAS), Department of Physiotherapy of the Federal University of Rio Grande do Norte (UFRN).
I The subjects included in the research will undergo three assessment stages: pre-training (Initial), post-training (6 weeks). Assessments in the pre-training period will be carried out in 1 day. After recruitment, participants will be invited to attend the UFRN Physiotherapy Department to carry out the first day of assessment by a previously trained evaluator blind to the intervention allocation group and will include anamnesis and physical examination, with measurement of vital signs. , anthropometric measurements, spirometry, respiratory muscle strength (manovacuometry), functional capacity (6-minute step test) and analysis of ventilatory variability (portable ventilator), assessment of peripheral muscle strength (dynamometry), quality of life (SF-36) .
The sample will be automatically randomized through the website www.randomization.com and allocated into two distinct groups: Experimental Group (GE): inspiratory muscle training and Sham Group (G2): IMT without load. Three evaluators will participate in the research: researcher 1 will be responsible only for the evaluations, researcher 2 for respiratory muscle training with weekly load adjustment and researcher 3 for randomization. The study will be double-blind, as researcher 1 and participants will not be aware of the allocation of subjects into groups, nor of the effects of the intervention.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both sexes will be included, with a diagnosis of COVID-19 confirmed by RT-PCR, aged over 18 years, without any underlying respiratory or cardiac disease and reduced respiratory muscle strength (≤100 cmH2O). Reduced inspiratory muscle strength will be defined using MIP.
排除标准
- •Patients with conditions impairing assessments, health complications that justify interrupting data collection (e.g., syncope, intense chest pain, or cough with blood-tinged sputum), hospitalized due to exacerbation of clinical conditions, or requested to leave the study will be excluded.
结局指标
主要结局
Ventilation variability and ventilation efficiency
时间窗: before and after 6 weeks
For the ventilatory variables, the slope and intercept of the VE/VCO2 relationship will be obtained by simple linear regression of the type: VE = a \* V´CO2 +/- b, with "a" corresponding to the slope of the relationship and "b" the interception value, including data from the peak loading exercise (RAMOS et al., 2013). We will also evaluate two new ventilation parameters, the constant rate of CO2 output (CO2CR) and the ventilation efficiency (ηVE). The two new variables were recently described (MULLER; SARAIVA et al., 2021). Briefly, the CO2CR will be obtained in a similar way to that described for the oxygen consumption efficiency curve, that is, taking the 10th base logarithm of VE on the x-axis against VCO2 on the y-axis. This relationship results in a characteristic quadratic function in most cases. The parameter "b" of the linear part of the equation type VCO2 = a \* VE + b \* V´E + c is called CO2CR.
次要结局
- Respiratory muscle strength(before and after 6 weeks)
- Functional capacity(before and after 6 weeks)
- Adverse effects and adherence(before and after 6 weeks)
- Pulmonary function(before and after 6 weeks)
- Quality of life - Medical Outcomes Study 36-Item Short Health Form Survey (SF-36)(before and after 6 weeks)
- Peripheral muscle strength(before and after 6 weeks)
研究者
Patri-cia Angelica de Miranda Silva Nogueira
Professor
Universidade Federal do Rio Grande do Norte