NCT06499597

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 2, 2024

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Duke activity status index

    The Duke Activity Status Index (DASI) is an assessment tool used to evaluate the functional capacity of patients.

    Baseline (10 day before surgery), Pre-surgery (1 day before surgery)

Secondary Outcomes (4)

  • 6 minute walk test

    Baseline (10 day before surgery)

  • Pulmonary function test

    Baseline (10 day before surgery)

  • mMRC (Modified Medical Research Council) Dyspnea Scale

    Baseline (10 day before surgery)

  • Hospital Anxiety and Depression Scale (HADS)

    Baseline (10 day before surgery)

Interventions

All individuals included in the study will be included in this group and evaluations will be made.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Obese patients who are candidates for bariatric surgery

You may qualify if:

  • Body mass index higher than 30
  • No disease that may affect functional performance
  • Able to adapt to the tests to be applied

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University

Sanliurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Observation

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 12, 2024

Study Start

March 1, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations