EFFICACY OF INSPIRATORY MUSCLE TRAINING ASSOCIATED WITH MANUAL TECHNIQUES FOR THE LOWER ESOPHAGEAL SPHINCTER AND DIAPHRAGMATIC RELEASE IN INDIVIDUALS WITH GASTROESOPHAGEAL REFLUX DISEASE: A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pressure at the gastroesophageal junction
研究概览
简要总结
The objective of this clinical trial is to investigate the efficacy of inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT) in patients with Gastroesophageal Reflux Disease (GERD). The main questions it aims to answer are:
- If the combination of IMT, DRT, and MTLES can improve GERD symptoms and patients' quality of life.
- If the home-based IMT protocol, with weekly adjustments, and the manual techniques applied twice a week can have a positive impact on various clinical measures, such as pressure at the lower esophageal sphincter, reflux episodes, and quality of life.
The researchers will compare three groups: Group 1 (IMT), Group 2 (IMT + DRT + MTLES), and Group 3 (control, sham), to see if the group receiving IMT combined with DRT and MTLES shows greater improvements compared to the control group.
Participants will perform inspiratory muscle training at home, following a protocol adjusted weekly, and will receive manual techniques twice a week.
详细描述
The IMT protocol will be performed at home with a load set at 50% of maximal inspiratory pressure (MIP) and adjusted weekly, while manual techniques will be applied twice a week at LACAP. Outcomes include mean pressure at the gastroesophageal junction (esophageal manometry), number of reflux episodes and acid exposure time (impedance-pH monitoring), diaphragmatic mobility and thickness (ultrasound), respiratory muscle strength (manovacuometry), heart rate variability (heart rate monitor), and reflux symptoms and quality of life (questionnaires). It is expected that the combination of IMT, DRT, and MTLES will improve GERD symptoms and positively impact patients' quality of life, providing an effective and less invasive alternative compared to conventional interventions.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with gastroesophageal reflux disease (GERD)
- •using 20 mg of proton pump inhibitors (PPIs).
排除标准
- •Individuals with a hiatal hernia >3 cm,
- •chronic lung diseases (chronic obstructive pulmonary disease and interstitial lung diseases)
- •severe heart diseases,
- •history of previous abdominal and/or thoracic surgeries, rib fractures within the past year,
- •severe osteoporosis
- •BMI >30 kg/m²
研究组 & 干预措施
group IMT
inspiratory muscle training (IMT)
干预措施: inspiratory muscle training (Procedure)
group IMT +TM
inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT)
干预措施: inspiratory muscle training (IMT) combined with manual techniques for the lower esophageal sphincter (MTLES) and diaphragmatic release (DRT) (Procedure)
group placebo
a simulated treatment protocol
干预措施: Controle (Procedure)
结局指标
主要结局
pressure at the gastroesophageal junction
时间窗: Pre-intervention and after 8 weeks of intervention.
esophageal manometry
number of reflux episodes
时间窗: Pre-intervention and after 8 weeks of intervention.
impedance-pH monitoring
reflux symptoms
时间窗: Pre-intervention and after 8 weeks of intervention.
Gastroesophageal Reflux Disease Symptom Questionnaire
acid exposure time
时间窗: Pre-intervention and after 8 weeks of intervention.
impedance-pH monitoring
次要结局
- diaphragmatic mobility and thickness(Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.)
- respiratory muscle strength(Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.)
- heart rate variability(Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.)
- diaphragmatic thickness(Pre-intervention, after 4 weeks of intervention, after 8 weeks of intervention and And a follow-up one month after the last intervention.)
研究者
HELENA MEDEIROS ROCHA
Principal Investigator
Universidade Federal de Pernambuco