Effect of Inspiratory Muscle Training on Muscular and Pulmonary Function Following Gastroplasty in Obese Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maximum static respiratory pressures
研究概览
简要总结
The purpose of this study is to assess the effect of post-operative inspiratory muscle training on muscle strength and endurance in patients with obesity submitted to gastroplasty.
详细描述
Gastroplasties, like other major abdominal surgeries, induce mechanical changes in the lungs and decreases of the respiratory muscle strength in the post-operative periods. Depending on the occurrence of pre-existing disturbs, obese patients may exhibit severe declines of respiratory function after these surgeries.
Post-operative respiratory physiotherapy is a valuable intervention, involving a set of techniques aimed to expand pulmonary volumes and to improve arterial oxygenation, leading to decreases on the development of atelectasis and pneumonias. It induces faster recovery of respiratory function and reduction of lung complications, what may be particularly important in high-risk patients like over-weighted subjects.
There are scanty data about the role of respiratory muscle training in the post-operative period. This is particularly true regarding inspiratory muscle training of obese patients submitted to gastroplasties.
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
- 20 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gastroplasty patients presenting body mass index (BMI) ≥ 35 kg/m2;
- •weighting ≤ 60 kg/m2;
- •capable of fulfilling the experimental protocol.
排除标准
- •acute or chronic pulmonary disease;
- •post-operative mechanical ventilation for more than 48 hours;
- •presence of lung complications;
- •need for surgical re-intervention during the study period.
结局指标
主要结局
Maximum static respiratory pressures
时间窗: post-operative days 2, 7, 14, and 30
This measurement was made at mouth level by using a properly calibrated manovacuometer (GERAR ®, São Paulo, Brazil), with graduation ranging from 0 to ± 300 cmH2O, connected to a rigid plastic tube.
Inspiratory muscular endurance test
时间窗: post-operative days 2, 7, 14, and 30.
This measurement was performed by using the Threshold® IMT device (Health Scan Products, USA), at 80% maximal inspiratory pressure, in sitting position.
Spirometric measurements
时间窗: post-operative days 2, 7, 14, and 30.
Spirometry was performed according to norms of the American Thoracic Society (ATS) (1994)19 by using a previously calibrated spirometer (Respiradyne II Plus®, Sherwood Medical, St. Louis, USA).
次要结局
- Maximum static respiratory pressures(post-operative days 2, 7, 14, and 30)
- Inspiratory muscular endurance test(post-operative days 2, 7, 14, and 30)
- Spirometric measurements(post-operative days 2, 7, 14, and 30.)