<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03758898</url>
  </required_header>
  <id_info>
    <org_study_id>IBU11.2018</org_study_id>
    <nct_id>NCT03758898</nct_id>
  </id_info>
  <brief_title>The Effect of Chest Physiotherapy After Bariatric Surgery</brief_title>
  <official_title>The Effect of Chest Physiotherapy After Bariatric Surgery on Pulmonary Functions, Functional Capacity and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Bilgi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Bilgi University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the effect of chest physiotherapy applied to&#xD;
      patients undergoing bariatric surgery on pulmonary functions, dyspnea levels, functional&#xD;
      capacity and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, controlled trial, was designed, conducted, and reported in accordance with&#xD;
      the standards of The CONSORT (Consolidated Standards of Reporting Trials) Statement. The&#xD;
      patients were randomised and divided into two groups each comprising 74 patients. Chest&#xD;
      physiotherapy and mobilisation was applied to the patients in the first group, and only&#xD;
      mobilisation was applied to the patients in the second group. The treatment of the patients&#xD;
      was started on the first postoperative day and continued until the postoperative 4th day.&#xD;
      Chest physiotherapy and mobilization were applied twice a day, 8 times in total. The&#xD;
      following parameters were evaluated preoperative and postoperative:arterial blood gas, oxygen&#xD;
      saturation, respiratory function test for pulmonary functions, pulmonary artery pressure for&#xD;
      pulmonary hypertansion, Borg dyspnea score for severity of dyspnoea, 6-minute walk test for&#xD;
      functional capacity, Nottingham health profile for quality of life.&#xD;
&#xD;
      Chest physiotherapy consisted of postural drainage (30-45 degree eleve), breathing exercises&#xD;
      (deep breathing, diaphragm breathing, active breathing techniques cycle) and coughing&#xD;
      techniques (huffing, controlled coughing, manual assisted coughing). In the chest&#xD;
      physiotherapy program, diaphragmatic respiration, constrictive lip respiration, segmental&#xD;
      respiration, incentive spirometry and coughing were performed on the 1st postoperative day.&#xD;
      All respiratory exercises were repeated twice a day and percussion was added on the 2nd&#xD;
      postoperative day. All respiratory exercises and percussion were repeated 2 times a day until&#xD;
      the discharge of the post op day 4 until discharge, and the work with incentive spirometry&#xD;
      was removed per hour. Patients were mobilized as early as possible by the physiotherapist.&#xD;
      The patients in both groups were instructed to sit out of bed and stand up on the first&#xD;
      postoperative day, walk 45 m in the corridor on the second day, walk freely (approximately&#xD;
      150-300 m) on the third and the fourth days.&#xD;
&#xD;
      All operations were laparoscopic, sleeve gastrectomy or Roux-en Y gastric bypass (21).&#xD;
      Routine anesthesia was performed with desflurane and remifentanil. In all procedures,&#xD;
      patients were treated with the split upward position (French position) and a semi-reclining&#xD;
      position (anti-Trendelenburg position). All patients received prophylaxis against deep vein&#xD;
      thrombosis for 2 weeks with pneumatic compression stocking and subcutaneous low molecular&#xD;
      weight heparin. Perioperative antibiotics (cefazolin 2 g) were also routinely administered.&#xD;
      The patients were discharged on the fourth postoperative day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2018</start_date>
  <completion_date type="Actual">April 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body mass index</measure>
    <time_frame>1 minute</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional capacity: 6 minute walk test</measure>
    <time_frame>5 minutes</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dispnea: Borg scale</measure>
    <time_frame>6 minutes</time_frame>
    <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. &quot;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?&quot; 0 better, 10 worst point mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life profile: Nottingham Health Profile</measure>
    <time_frame>8 minutes</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>only mobilisation was applied to the patients in the second group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment</intervention_name>
    <description>Chest physiotherapy and mobilization were applied twice a day, 8 times in total.</description>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group 2</intervention_name>
    <description>Only mobilization was applied twice a day, 8 times in total.</description>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obese and morbidly obese patients&#xD;
&#xD;
          -  aged between 30 and 50 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous obesity surgery&#xD;
&#xD;
          -  presence of chronic respiratory disease&#xD;
&#xD;
          -  renal / hepatic dysfunction&#xD;
&#xD;
          -  malignant hyperthermia&#xD;
&#xD;
          -  regular alcohol&#xD;
&#xD;
          -  smoking and drug use&#xD;
&#xD;
          -  pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomri̇s Duymaz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul Bilgi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tomri̇s Duymaz</name>
      <address>
        <city>İstanbul</city>
        <zip>34440</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Bilgi University</investigator_affiliation>
    <investigator_full_name>TOMRIS DUYMAZ</investigator_full_name>
    <investigator_title>Asst. Prof. Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Bariatric surgery</keyword>
  <keyword>Chest physiotherapy</keyword>
  <keyword>Pulmonary functions</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03758898
org study id: IBU11.2018
nct id: NCT03758898
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Single (Investigator)
measure: Body mass index
time frame: 1 minute
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.
measure: Functional capacity: 6 minute walk test
time frame: 5 minutes
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
measure: Dispnea: Borg scale
time frame: 6 minutes
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.
measure: Quality of Life profile: Nottingham Health Profile
time frame: 8 minutes
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.
arm group label: Treatment
arm group type: Experimental
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 group label: Group 2
arm group type: Placebo Comparator
description: only mobilisation was applied to the patients in the second group
intervention type: Other
intervention name: Treatment
description: Chest physiotherapy and mobilization were applied twice a day, 8 times in total.
arm group label: Group 2
arm group label: Treatment
intervention type: Other
intervention name: Group 2
description: Only mobilization was applied twice a day, 8 times in total.
arm group label: Group 2
arm group label: Treatment
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
last name: Tomri̇s Duymaz
role: Principal Investigator
affiliation: Istanbul Bilgi University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Bilgi University
investigator full name: TOMRIS DUYMAZ
investigator title: Asst. Prof. Ph.D.
mesh term: Lung Diseases
sharing ipd: No