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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Zeynal Yasacı contact

05075409791

zeynalyasaci@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Harran University

    Sanliurfa

    Zeynal Yasaci

    Recruiting

Other trials in Turkey (Türkiye)

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.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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.

  1. First posted12 Jul 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Jul 2024
  4. Study completion1 Aug 2024 (estimated)

Resources

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)
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

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.

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