The Effect of Chest Physiotherapy After Bariatric Surgery
Primary Purpose
Bariatric Surgery Candidate, Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Treatment
Group 2
Sponsored by
About this trial
This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring Bariatric surgery, Chest physiotherapy, Pulmonary functions, Quality of life
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.
Sites / Locations
- Tomri̇s Duymaz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Group 2
Arm Description
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.
only mobilisation was applied to the patients in the second group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Functional capacity: 6 minute walk test
The subjects were instructed to walk as far as possible in six minutes in an enclosed 50-m long hospital corridor. Standardized encouragement was given in every 30 s. The maximum distance covered at the end of the test was recorded
Dispnea: Borg scale
Breathlessness and fatigue perception were determined using a 10-point modified Borg scale during the six minute walking test. Total score is 10 points. "This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal. How much difficulty is your breathing causing you right now?" 0 better, 10 worst point mean.
Quality of Life profile: Nottingham Health Profile
Nottingham Health Profile (NHP) was used to determine quality of life of the participants. NHP is a general health status scale (health-related quality of life), which aims to measure a patient's perceived emotional, social and physical health status. This scale consists of 38 items formed as yes-no questions that cover 6 subscales of the quality of life. These six subscales are sleep (5 item), energy level (3 item), emotional status (9 item), social isolation (5 item), physical mobility (8 item) and pain (8 item). Each section is scored from 0-100.
Full Information
NCT ID
NCT03758898
First Posted
November 27, 2018
Last Updated
May 21, 2019
Sponsor
Istanbul Bilgi University
1. Study Identification
Unique Protocol Identification Number
NCT03758898
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
April 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bilgi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Pulmonary Disease
Keywords
Bariatric surgery, Chest physiotherapy, Pulmonary functions, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
only mobilisation was applied to the patients in the second group
Intervention Type
Other
Intervention Name(s)
Treatment
Intervention Description
Chest physiotherapy and mobilization were applied twice a day, 8 times in total.
Intervention Type
Other
Intervention Name(s)
Group 2
Intervention Description
Only mobilization was applied twice a day, 8 times in total.
Primary Outcome Measure Information:
Title
Body mass index
Description
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.
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Functional capacity: 6 minute walk test
Description
The subjects were instructed to walk as far as possible in six minutes in an enclosed 50-m long hospital corridor. Standardized encouragement was given in every 30 s. The maximum distance covered at the end of the test was recorded
Time Frame
5 minutes
Title
Dispnea: Borg scale
Description
Breathlessness and fatigue perception were determined using a 10-point modified Borg scale during the six minute walking test. Total score is 10 points. "This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal. How much difficulty is your breathing causing you right now?" 0 better, 10 worst point mean.
Time Frame
6 minutes
Title
Quality of Life profile: Nottingham Health Profile
Description
Nottingham Health Profile (NHP) was used to determine quality of life of the participants. NHP is a general health status scale (health-related quality of life), which aims to measure a patient's perceived emotional, social and physical health status. This scale consists of 38 items formed as yes-no questions that cover 6 subscales of the quality of life. These six subscales are sleep (5 item), energy level (3 item), emotional status (9 item), social isolation (5 item), physical mobility (8 item) and pain (8 item). Each section is scored from 0-100.
Time Frame
8 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomri̇s Duymaz
Organizational Affiliation
Istanbul Bilgi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tomri̇s Duymaz
City
İstanbul
ZIP/Postal Code
34440
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Chest Physiotherapy After Bariatric Surgery
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