Clinical trial NCT03758898: The Effect of Chest Physiotherapy After Bariatric Surgery
Official title: The Effect of Chest Physiotherapy After Bariatric Surgery on Pulmonary Functions, Functional Capacity and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Pulmonary Disease
Keywords: Bariatric surgery
Chest physiotherapy
Pulmonary functions
Quality of life
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 148
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomised using randomisation software 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Body mass index
timeFrame: 1 minute
Secondary outcomes:
measure: Functional capacity: 6 minute walk test
timeFrame: 5 minutes
measure: Dispnea: Borg scale
timeFrame: 6 minutes
measure: Quality of Life profile: Nottingham Health Profile
timeFrame: 8 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Tomri̇s Duymaz
Study officials:
affiliation: Istanbul Bilgi University
name: Tomri̇s Duymaz
role: PRINCIPAL_INVESTIGATOR
References: