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临床试验/NCT03758898
NCT03758898已完成不适用

The Effect of Chest Physiotherapy After Bariatric Surgery on Pulmonary Functions, Functional Capacity and Quality of Life

Istanbul Bilgi University2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2018年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
2
主要终点
Body mass index

研究概览

简要总结

The aim of this study was to investigate the effect of chest physiotherapy applied to patients undergoing bariatric surgery on pulmonary functions, dyspnea levels, functional capacity and quality of life.

详细描述

This randomized, controlled trial, was designed, conducted, and reported in accordance with the standards of The CONSORT (Consolidated Standards of Reporting Trials) Statement. The patients were randomised and divided into two groups each comprising 74 patients. Chest physiotherapy and mobilisation was applied to the patients in the first group, and only mobilisation was applied to the patients in the second group. The treatment of the patients was started on the first postoperative day and continued until the postoperative 4th day. Chest physiotherapy and mobilization were applied twice a day, 8 times in total. The following parameters were evaluated preoperative and postoperative:arterial blood gas, oxygen saturation, respiratory function test for pulmonary functions, pulmonary artery pressure for pulmonary hypertansion, Borg dyspnea score for severity of dyspnoea, 6-minute walk test for functional capacity, Nottingham health profile for quality of life.

Chest physiotherapy consisted of postural drainage (30-45 degree eleve), breathing exercises (deep breathing, diaphragm breathing, active breathing techniques cycle) and coughing techniques (huffing, controlled coughing, manual assisted coughing). In the chest physiotherapy program, diaphragmatic respiration, constrictive lip respiration, segmental respiration, incentive spirometry and coughing were performed on the 1st postoperative day. All respiratory exercises were repeated twice a day and percussion was added on the 2nd postoperative day. All respiratory exercises and percussion were repeated 2 times a day until the discharge of the post op day 4 until discharge, and the work with incentive spirometry was removed per hour. Patients were mobilized as early as possible by the physiotherapist. The patients in both groups were instructed to sit out of bed and stand up on the first postoperative day, walk 45 m in the corridor on the second day, walk freely (approximately 150-300 m) on the third and the fourth days.

All operations were laparoscopic, sleeve gastrectomy or Roux-en Y gastric bypass (21). Routine anesthesia was performed with desflurane and remifentanil. In all procedures, patients were treated with the split upward position (French position) and a semi-reclining position (anti-Trendelenburg position). All patients received prophylaxis against deep vein thrombosis for 2 weeks with pneumatic compression stocking and subcutaneous low molecular weight heparin. Perioperative antibiotics (cefazolin 2 g) were also routinely administered. The patients were discharged on the fourth postoperative day.

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
Single (Investigator)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • obese and morbidly obese patients
  • aged between 30 and 50 years

排除标准

  • previous obesity surgery
  • presence of chronic respiratory disease
  • renal / hepatic dysfunction
  • malignant hyperthermia
  • regular alcohol
  • smoking and drug use
  • pregnancy.

研究组 & 干预措施

Treatment

Experimental

Chest physiotherapy and mobilisation were applied on the patients for 4 days. The treatment of the patients was started on the first postoperative day and continued until the postoperative 4th day.

干预措施: Treatment (Other)

Treatment

Experimental

Chest physiotherapy and mobilisation were applied on the patients for 4 days. The treatment of the patients was started on the first postoperative day and continued until the postoperative 4th day.

干预措施: Group 2 (Other)

Group 2

Placebo Comparator

only mobilisation was applied to the patients in the second group

干预措施: Treatment (Other)

Group 2

Placebo Comparator

only mobilisation was applied to the patients in the second group

干预措施: Group 2 (Other)

结局指标

主要结局

Body mass index

时间窗: 1 minute

BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The National Institutes of Health (NIH) now defines normal weight, overweight, and obesity according to BMI rather than the traditional height/weight charts. Overweight is a BMI of 27.3 or more for women and 27.8 or more for men. Obesity is a BMI of 30 or more for either sex (about 30 pounds overweight). A very muscular person might have a high BMI without health risks.

次要结局

  • Functional capacity: 6 minute walk test(5 minutes)
  • Dispnea: Borg scale(6 minutes)
  • Quality of Life profile: Nottingham Health Profile(8 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TOMRIS DUYMAZ

Asst. Prof. Ph.D.

Istanbul Bilgi University

研究点 (2)

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