The Effect of Chest Physiotherapy After Bariatric Surgery

NCT ID: NCT03758898

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-05

Study Completion Date

2019-04-15

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment

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.

Group Type EXPERIMENTAL

Treatment

Intervention Type OTHER

Chest physiotherapy and mobilization were applied twice a day, 8 times in total.

Group 2

Intervention Type OTHER

Only mobilization was applied twice a day, 8 times in total.

Group 2

only mobilisation was applied to the patients in the second group

Group Type PLACEBO_COMPARATOR

Treatment

Intervention Type OTHER

Chest physiotherapy and mobilization were applied twice a day, 8 times in total.

Group 2

Intervention Type OTHER

Only mobilization was applied twice a day, 8 times in total.

Interventions

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Treatment

Chest physiotherapy and mobilization were applied twice a day, 8 times in total.

Intervention Type OTHER

Group 2

Only mobilization was applied twice a day, 8 times in total.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Bilgi University

OTHER

Sponsor Role lead

Responsible Party

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TOMRIS DUYMAZ

Asst. Prof. Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomri̇s Duymaz

Role: PRINCIPAL_INVESTIGATOR

Istanbul Bilgi University

Locations

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Tomri̇s Duymaz

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IBU11.2018

Identifier Type: -

Identifier Source: org_study_id

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