Efficacy of Home Inspiratory Muscle Training in Post-covid-19 Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Respiratory muscle strength
研究概览
简要总结
INTRODUCTION: Coronavirus 2019 disease (COVID-19), caused by the Severe Acute Respiratory Syndrome (SRAG) of coronavirus 2 (SARS-CoV-2) surpassed the global number of 119,603,761 cases, with more than 2,649,722 reported deaths . There is sufficient evidence for a possible post-covid-19 syndrome, designating sequelae with persistent symptoms. Respiratory muscle training improves respiratory muscle strength, exercise capacity, diaphragm muscle thickness, and dyspnea in various patient populations, especially in those with the greatest reduction in basal respiratory muscle strength. OBJECTIVE: To evaluate the effectiveness of a home inspiratory muscle training protocol in improving respiratory muscle strength, dyspnea and quality of life in post-Covid-19 patients. MATERIALS AND METHODS: This is a clinical, controlled, randomized and blind trial, which will be carried out at the Institute of Tropical Medicine of the Federal University of Rio Grande do Norte. The sample size will be performed using GPower software version 3.1.9.2 (Kiel, Germany) for Windows and will be established after conducting a pilot study with 5 participants in each group (total of 10 subjects) for a hypothetical two-way ANOVA test, using the main variable the Maximum Inspiratory Pressure (PImax.). The subjects included in the research will undergo three evaluation moments: Pre-training (Initial), Post-training (6 weeks) and Retention Test (24 weeks) for clinical evaluation form, anthropometric measures, respiratory muscle strength, volumes and capacities pulmonary symptoms, dyspnea, perceived exertion and fatigue, handgrip strength, six-minute walk test, anxiety and depression, post-covid functional status. After the initial assessment, all volunteers will receive a POWERbreathe® device (POWERbreathe®, HaB Ltd, Southam, UK) to carry out the training. EXPECTED RESULTS: provide a safe, effective and easy-to-perform treatment for post-covid-19 patients.
详细描述
The subjects included in the research will go through three evaluation moments: Pre-training (Initial), Post-training (3 and 6 weeks) and Retention Test (12 and 24 weeks).
After recruitment, participants will be invited to attend the Institute of Tropical Medicine to carry out an initial assessment by an evaluator previously trained and blinded to the intervention allocation group and will include anamnesis and physical examination, with measurement of vital signs, anthropometric measurements, assessment of lung volumes, respiratory muscle strength, peripheral muscle strength, quality of life, anxiety and depression, functional status and the 6-minute walk test.
After the initial evaluation, all volunteers will receive a POWERbreathe® device (POWERbreathe®, HaB Ltd, Southam, UK), to carry out the training, and will be individually instructed on how to use it and on the performance of the protocol. They will conduct an experimental session to familiarize themselves with the device that will not be considered for review. Every three days, volunteers will receive a phone call from researcher 2, who will not participate in the assessment, to confirm whether the exercise with the POWERbreathe® was being performed properly at the frequency and load set and if there were any doubts regarding the protocol. At the end of each week, participants will receive a video call from researcher 2 to adjust the device according to the weekly load progression of G1.
All evaluation moments (pre-training, post-training and retention test) will be performed by a single evaluator (Evaluator 1) - who will not know which group the subject will be allocated to - and recorded in the evaluation form developed for the project. A second researcher (Evaluator 2) will be responsible for applying the training protocols to the subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects of both sexes, sedentary, within two months of a diagnosis of COVID-19 confirmed by RT-PCR, aged over 18 years and without any underlying respiratory disease, with adequate cognitive status defined through the Mini Mental State Examination and reduced muscle strength respiratory, defined through the assessment of the maximum inspiratory pressure.
排除标准
- •subjects who present any condition that makes it impossible to carry out the assessments and protocols, complications that justify the interruption of data collection, such as syncope, severe chest pain, coughing up blood, those who request withdrawal from the study and who present adverse effects such as hospitalization by exacerbation of the clinical picture.
结局指标
主要结局
Respiratory muscle strength
时间窗: Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.
The assessment of respiratory muscle strength will be performed by measuring the maximum respiratory pressures (Maximum Inspiratory Pressure: PImax and Maximum Expiratory Pressure: PEmax) through the use of an analog manometer (GERAR®, São Paulo, Brazil) with an operating range of ± 300 cmH2O and equipped with a mouthpiece adapter, containing an exhaust valve through an orifice of approximately 2mm in diameter to prevent the increase of intraoral pressure. For data analysis, at least three reproducible maneuvers will be used, with variability less than 20%, and the highest value will be recorded. The normality references for the calculation of maximal respiratory pressures as a function of age and gender will respect the description of the method used by Pessoa et al. (2014) for the Brazilian population.
Dyspnea - Medical Research Council
时间窗: Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.
Dyspnea will be assessed using the scale adapted to Portuguese by the Medical Research Council. The scale will allow the volunteer to indicate the extent to which their shortness of breath affected their mobility in daily activities. The scores range from 1 to 5, whose higher values refer to greater dyspnea, and the lower values reflect less dyspnea and will be chosen by the participant (BESTALL et al., 1999).
Quality of life (SF-36)
时间窗: Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.
The Medical Outcomes Study 36-Item Short Health Form Survey (SF-36) is a multidimensional questionnaire translated and validated for the Brazilian reality (CICONELLI et al., 1999; LAGUARDIA et al., 2011) that was developed to assess quality of life related to health. Scores range from 0 to 100 for each subscale, with higher scores being indicative of a better health-related quality of life (WARE; SHERBOURNE, 1992).
次要结局
- Adverse effects and adherence(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
- Physical activity level(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
- Pulmonary function(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
- Exercise tolerance(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
- Functional independence measure(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
- Functional status(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
- Anxiety and depression(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
- Cognition(baseline)
- Perception of effort and fatigue(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
- Peripheral muscle strength(Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.)
研究者
Patri-cia Angelica de Miranda Silva Nogueira
Pesquisador principal
Universidade Federal do Rio Grande do Norte