Morbid ObesityNCT02220959
Is Preoperative Exercise Test in Morbid Obese Patients a Predictive Test for Extubation?
A study testing walk test in people with Morbid Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
the purpose of this study is to determine if 60 meter test done prior to surgery is a predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2014to Sep 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients between 18-60 years old
- patients with BMI > 40
- patients undergoing Laparoscopic Sleeve Gastrectomy
Who cannot join
- patients with Chronic obstructive pulmonary disease (COPD), Asthma,
- patients with uncompensated heart failure
- Uncompensated diabetes mellitus
- Patients Who have orthopedic problems that effects the exercise test
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cerrahpasa medical Faculty General surgery operation theatre
Istanbul, 34500
About this study
Official title: Is Preoperative Exercise Test in Morbid Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy a Predictive Test for Extubation?
the purpose of this study is to determine if 60 meter test done prior to surgery is a predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.
- Conditions
- Morbid Obesity
- Being tested
- walk test
- Keywords
- morbid obesity surgery, walk test, exercise
- Medical subject headings
- Obesity, Morbid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walk testOther
Also called 60 meter walk test
patients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test
| Study group | Role | What they receive |
|---|---|---|
| walk test | Experimental | morbid obese patients (BMI>40) undergoing laparoscopic sleeve gastrectomy walking 60 meters under 1 minute before and after the measurement of Forced vital capacity (FVC) Receives: Other: walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successful extubation
preoperative 60 meter walk test
Measured: postoperative 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220959
- Sponsor's protocol ID
- 14467
- Status last verified
- Oct 2014
- First submitted
- 18 Aug 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Preoperative Exercise Test in Morbid Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy a Predictive Test for Extubation?
- ClinicalTrials.gov ID
- NCT02220959
- Acronym / sponsor ID
- 14467
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity surgery, walk test, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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 purpose of this study is to determine if 60 meter test done prior to surgery is a predictive in terms of extubation in morbid obese patients undergoing morbid obese surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| walk test | Experimental | Other: walk testmorbid obese patients (BMI>40) undergoing laparoscopic sleeve gastrectomy walking 60 meters under 1 minute before and after the measurement of Forced vital capacity (FVC) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients between 18-60 years old
- patients with BMI > 40
- patients undergoing Laparoscopic Sleeve Gastrectomy
Key exclusion criteria (4 listed)
- patients with Chronic obstructive pulmonary disease (COPD), Asthma,
- patients with uncompensated heart failure
- Uncompensated diabetes mellitus
- Patients Who have orthopedic problems that effects the exercise test
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 |
|---|---|---|
| walk testAlso: 60 meter walk testpatients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test | Other | walk test |
Primary outcome
Number of participants with successful extubation
Time frame: postoperative 30 minutes
preoperative 60 meter walk test
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 10 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walk test in people with Morbid Obesity, run by Istanbul 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 3 inclusion and 4 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 10 Oct 2014. 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. 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?
Number of participants with successful extubation (time frame: postoperative 30 minutes). 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 10 Oct 2014.