Obesity, MorbidNCT06499597
Duke Activity Score Index in Obese Individuals
An observational study of Obesity, Morbid, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Today, obesity is a global health problem and can lead to serious health complications. Bariatric surgery is recognized as an effective treatment option to achieve long-term weight loss and health improvement in overweight or obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Observation
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Aug 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese patients who are candidates for bariatric surgery
Who may be able to join
- Body mass index higher than 30
- No disease that may affect functional performance
- Able to adapt to the tests to be applied
Who cannot join
- Recently hospitalized due to a condition that may make it difficult to perform the test
- Inability to perform exercise tests due to neurological or musculoskeletal disorders
- Uncontrollable medical conditions (such as lung or cardiovascular disease)
- Dysfunction of the vestibular system or eyes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran University
Sanliurfa
Zeynal Yasaci
About this study
Official title: Investigation of Psychometric Properties of Duke Activity Score Index in Obese Individuals Candidate for Bariatric Surgery
Today, obesity is a global health problem and can lead to serious health complications. Bariatric surgery is recognized as an effective treatment option to achieve long-term weight loss and health improvement in overweight or obese individuals. However, appropriate tools are needed to assess the physical activity levels of patients before and after bariatric surgery and to guide rehabilitation processes after surgery. The Duke Activity Index (DAI) is a scale used to assess activities of daily living and was developed at Duke University Medical Center. The DAI has been widely used to determine patients' physical functioning and monitor their activity levels in various health conditions and post-surgical recovery processes. The aim of this study was to evaluate the psychometric properties of the DAI and to examine whether it is an effective tool for determining physical activity levels in patients who are candidates for bariatric surgery.
- Conditions
- Obesity, Morbid
- Being tested
- Observation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
All individuals included in the study will be included in this group and evaluations will be made.
What is being measured
The primary outcome is the main question the study is designed to answer.
Duke activity status index
The Duke Activity Status Index (DASI) is an assessment tool used to evaluate the functional capacity of patients.
Measured: Baseline (10 day before surgery), Pre-surgery (1 day before surgery)
Secondary outcomes (4)
6 minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Baseline (10 day before surgery)
Pulmonary function test
Pulmonary function tests (PFTs) allow physicians to evaluate the respiratory function of their patients in many clinical situations and when there are risk factors for lung disease, occupational exposures, and pulmonary toxicity. National guidelines for the measurements and interpretation of PFT are regularly updated, and the most recent guidelines developed by the international joint Task force from the European Respiratory Society and the American Thoracic Society (EUR/ATS) were published in 2022.
FVC, FEV1, FEV1/FVC parameters will be evaluated. In tests, patients sit with a clip on their noses. After 3 technically appropriate tests, the best-measured values are recorded and compared against reference values. The measurements obtained are recorded as a percentage relative to their ratio to the expected reference values.FEV1 measurements are recorded as a volume in ml.
Measured: Baseline (10 day before surgery)
mMRC (Modified Medical Research Council) Dyspnea Scale
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing
Measured: Baseline (10 day before surgery)
Hospital Anxiety and Depression Scale (HADS)
The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). It is worth noting that items referring to depression symptoms that describe somatic aspects of depression (e.g. insomnia and weight loss) are not included in the scale.
Measured: Baseline (10 day before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Mar 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynal Yasacı, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499597
- Sponsor's protocol ID
- Observ
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Psychometric Properties of Duke Activity Score Index in Obese Individuals Candidate for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06499597
- Acronym / sponsor ID
- Observ
- Conditions
- Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Jul 2024 (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.
Today, obesity is a global health problem and can lead to serious health complications. Bariatric surgery is recognized as an effective treatment option to achieve long-term weight loss and health improvement in overweight or obese individuals. However, appropriate tools are needed to assess the physical activity levels of patients before and after bariatric surgery and to guide rehabilitation processes after surgery. The Duke Activity Index (DAI) is a scale used to assess activities of daily living and was developed at Duke University Medical Center. The DAI has been widely used to determine patients' physical functioning and monitor their activity levels in various health conditions and post-surgical recovery processes. The aim of this study was to evaluate the psychometric properties of the DAI and to examine whether it is an effective tool for determining physical activity levels in patients who are candidates for bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients who are candidates for bariatric surgery
Key inclusion criteria (3 listed)
- Body mass index higher than 30
- No disease that may affect functional performance
- Able to adapt to the tests to be applied
Key exclusion criteria (4 listed)
- Recently hospitalized due to a condition that may make it difficult to perform the test
- Inability to perform exercise tests due to neurological or musculoskeletal disorders
- Uncontrollable medical conditions (such as lung or cardiovascular disease)
- Dysfunction of the vestibular system or eyes
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 |
|---|---|---|
| ObservationAll individuals included in the study will be included in this group and evaluations will be made. | Other | – |
Primary outcome
Duke activity status index
Time frame: Baseline (10 day before surgery), Pre-surgery (1 day before surgery)
The Duke Activity Status Index (DASI) is an assessment tool used to evaluate the functional capacity of patients.
4 secondary outcomes
6 minute walk test
Time frame: Baseline (10 day before surgery)
Pulmonary function test
Time frame: Baseline (10 day before surgery)
mMRC (Modified Medical Research Council) Dyspnea Scale
Time frame: Baseline (10 day before surgery)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (10 day before surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by Harran 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynal Yasacı (05075409791, zeynalyasaci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duke activity status index (time frame: Baseline (10 day before surgery), Pre-surgery (1 day before surgery)). 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 12 Jul 2024.