Body Mass IndexNCT06745310
Activities of Daily Living and Upper Extremity Exercise Capacity of Individuals with High Body Mass Index
An observational study of Body Mass Index and Body Mass Index 25 or Greater, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Individuals with high and normal body mass index will be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Mass Index, Body Mass Index 25 or Greater, Body Mass Index, Normal
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Individuals with high and normal body mass index will be included in the study.
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirsehir Ahi Evran University
Kırşehir
Merve Firat, +90 850 441 02 44, mervefirat@ahievran.edu.tr
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with high body mass index | Not described | |
| Individuals with normal body mass index | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity exercise capacity
It will be assessed by 6 minute pegboard and ring test.
Measured: 1st day
Daily living activities
It will be evaluated with the Glittre activities of daily living test.
Measured: 1st day
Secondary outcomes (2)
Fatigue
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.
Measured: 1st day
Pain
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.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start12 Dec 2024
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Mass IndexStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Firat, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745310
- Sponsor's protocol ID
- 2024-20/174
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06745310
- Acronym / sponsor ID
- 2024-20/174
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Dec 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.
Individuals with high and normal body mass index will be included in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with high body mass index | – | – |
| Individuals with normal body mass index | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with high and normal body mass index will be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper extremity exercise capacity
Time frame: 1st day
It will be assessed by 6 minute pegboard and ring test.
Daily living activities
Time frame: 1st day
It will be evaluated with the Glittre activities of daily living test.
2 secondary outcomes
Fatigue
Time frame: 1st day
Pain
Time frame: 1st day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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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.
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 Body Mass Index and Body Mass Index 25 or Greater, run by Kirsehir Ahi Evran Universitesi 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?
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: looking for participants now, as of the sponsor's last update on 20 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Firat (+90 850 441 02 44, mervefirat@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity exercise capacity (time frame: 1st day). The study lists 2 primary outcomes in all. 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 20 Dec 2024.