- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06745310
Activities of Daily Living and Upper Extremity Exercise Capacity of Individuals with High Body Mass Index
December 17, 2024 updated by: Merve Firat, Kirsehir Ahi Evran Universitesi
Comparison of Activities of Daily Living and Upper Extremity Exercise Capacity of Individuals with High Body Mass Index with Those with Normal Body Mass Index
Individuals with high and normal body mass index will be included in this study.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Merve Firat
- Phone Number: +90 850 441 02 44
- Email: mervefirat@ahievran.edu.tr
Study Locations
-
-
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Kirsehir, Turkey
- Recruiting
- Kirsehir Ahi Evran University
-
Contact:
- Merve Firat
- Phone Number: +90 850 441 02 44
- Email: mervefirat@ahievran.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Individuals with high and normal body mass index will be included in the study.
Description
Inclusion Criteria for individuals with high body mass index:
- Body mass index ≥ 25 kg/m2
- Volunteering for the study
Exclusion Criteria for individuals with high body mass index:
- Having uncontrolled hypertension, diabetes mellitus
- Having comorbidities that may affect physical functions
- Failure to cooperate with tests to be performed
- Liver disease, kidney disease, cancer, lung diseases and serious cardiomyopathies, neurological diseases
- Pregnancy
- Having a history of bariatric surgery
- Presence of contraindications to exercise testing
Inclusion Criteria for individuals with normal body mass index:
- Body mass index 18.5-24.9 kg/m2
- Volunteering for the study
Exclusion Criteria for individuals with normal body mass index:
- Body mass index > 25 kg/m2 or ≤18.5 kg/m2
- Having a known chronic or systemic disease
- Failure to cooperate with tests to be performed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Individuals with high body mass index
|
|
Individuals with normal body mass index
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper extremity exercise capacity
Time Frame: 1st day
|
It will be assessed by 6 minute pegboard and ring test.
|
1st day
|
|
Daily living activities
Time Frame: 1st day
|
It will be evaluated with the Glittre activities of daily living test.
|
1st day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue
Time Frame: 1st day
|
Fatigue will be assessed with a Fatigue Severity scale.
The scale consists of 9 questions.The total score ranges from 9 to 63.
An average score of 4 and above indicates severe fatigue.
|
1st day
|
|
Pain
Time Frame: 1st day
|
It will be evaluated with the Nordic Musculoskeletal Questionnaire.
It consists of 27 items that assess the presence of musculoskeletal symptoms over a 12-month period, covering nine different parts of the body.
There are also items on functional status and the presence of musculoskeletal symptoms in the last 7 days.
The total number of painful areas is determined.
Total number of painful areas varies from 0-9.
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 17, 2024
First Submitted That Met QC Criteria
December 17, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 17, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2024-20/174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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