Bariatric Surgery CandidateNCT03758898
The Effect of Chest Physiotherapy After Bariatric Surgery
A study testing Treatment and Group 2 in people with Bariatric Surgery Candidate and Pulmonary Disease, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Bariatric Surgery Candidate, Pulmonary Disease
- What is being tested?
- Treatment and Group 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obese and morbidly obese patients
- aged between 30 and 50 years
Who cannot join
- previous obesity surgery
- presence of chronic respiratory disease
- renal / hepatic dysfunction
- malignant hyperthermia
- regular alcohol
- smoking and drug use
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chest Physiotherapy After Bariatric Surgery on Pulmonary Functions, Functional Capacity and Quality of Life
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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate, Pulmonary Disease
- Being tested
- Treatment, Group 2
- Keywords
- Bariatric surgery, Chest physiotherapy, Pulmonary functions, Quality of life
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Chest physiotherapy and mobilization were applied twice a day, 8 times in total.
Group 2Other
Only mobilization was applied twice a day, 8 times in total.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Treatment; Other: Group 2 |
| Group 2 | Placebo comparator | only mobilisation was applied to the patients in the second group Receives: Other: Treatment; Other: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute
Secondary outcomes (3)
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
Measured: 5 minutes
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.
Measured: 6 minutes
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.
Measured: 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start5 May 2018
- Primary completion1 Oct 2018
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMRIS DUYMAZ, Istanbul Bilgi University
- Investigators
- Tomri̇s Duymaz, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758898
- Sponsor's protocol ID
- IBU11.2018
- Status last verified
- May 2019
- First submitted
- 27 Nov 2018
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chest Physiotherapy After Bariatric Surgery on Pulmonary Functions, Functional Capacity and Quality of Life
- ClinicalTrials.gov ID
- NCT03758898
- Acronym / sponsor ID
- IBU11.2018
- Conditions
- Bariatric Surgery Candidate, Pulmonary Disease
- Keywords
- Bariatric surgery, Chest physiotherapy, Pulmonary functions, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Treatment, Other: Group 2Chest 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 2 | Placebo comparator | Other: Treatment, Other: Group 2only mobilisation was applied to the patients in the second group |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obese and morbidly obese patients
- aged between 30 and 50 years
Key exclusion criteria (7 listed)
- previous obesity surgery
- presence of chronic respiratory disease
- renal / hepatic dysfunction
- malignant hyperthermia
- regular alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentChest physiotherapy and mobilization were applied twice a day, 8 times in total. | Other | Group 2, Treatment |
| Group 2Only mobilization was applied twice a day, 8 times in total. | Other | Group 2, Treatment |
Primary outcome
Body mass index
Time frame: 1 minute
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.
3 secondary outcomes
Functional capacity: 6 minute walk test
Time frame: 5 minutes
Dispnea: Borg scale
Time frame: 6 minutes
Quality of Life profile: Nottingham Health Profile
Time frame: 8 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomri̇s Duymaz principal investigator
Istanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment and Group 2 in people with Bariatric Surgery Candidate and Pulmonary Disease, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.