The Effect of Chest Physiotherapy After Bariatric Surgery

NCT03758898 | Completed DMC

• 1 other identifier: IBU11.2018
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Pulmonary Disease

Keywords

Bariatric surgery; Chest physiotherapy; Pulmonary functions; Quality of life

Outcome Measures

Primary Outcomes (1)

• Body mass index

  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.

  1 minute

Secondary Outcomes (3)

• Functional capacity: 6 minute walk test

  5 minutes

• Dispnea: Borg scale

  6 minutes

• Quality of Life profile: Nottingham Health Profile

  8 minutes

Study Arms (2)

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.

Other: Treatment; Other: Group 2

Group 2

PLACEBO COMPARATOR

only mobilisation was applied to the patients in the second group

Other: Treatment; Other: Group 2

Interventions

Treatment OTHER

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

Group 2; Treatment

Group 2 OTHER

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

Group 2; Treatment

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Tomri̇s Duymaz

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Tomri̇s Duymaz

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: May 5, 2018
• Primary Completion: October 1, 2018
• Study Completion: April 15, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)