Obesity & OverweightNCT07605793
Reliability and Validity of Physical Performance Tests in Individuals With Obesity
An observational study of Obesity & Overweight, run by Yunus Emre Tutuneken.
Trial summary
This study aims to investigate the reliability and validity of practical performance-based physical function tests in individuals with obesity. Functional limitations such as reduced walking ability, impaired balance, and decreased lower extremity strength are common in people with obesity and may negatively affect… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Physical Performance Tests
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 20 Oct 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals With Obesity
Who may be able to join
- Body mass index (BMI) ≥ 30 kg/m²
- Stable body weight during the last 3 months (less than ±2 kg change)
- Ability to perform daily living activities independently
Who cannot join
- History of cardiovascular disease
- History of pulmonary disease
- History of neurological disease
- Musculoskeletal injury affecting lower extremity function
- Presence of lower extremity prosthesis or severe deformity
- Major surgery within the previous 6 months
Show all 14Show fewer
- Pregnancy
- Postpartum period
- Vestibular disorders affecting balance
- Visual impairments affecting test performance
- Hearing impairments affecting test performance
- Cognitive impairment limiting understanding of instructions
- Participation in strenuous physical activity before testing
- Use of medications affecting cardiopulmonary responses (e.g., beta-blockers)
About this study
Official title: Clinician-Friendly Physical Performance Tests in Individuals With Obesity: Reliability and Validity
This study aims to investigate the reliability and validity of practical performance-based physical function tests in individuals with obesity. Functional limitations such as reduced walking ability, impaired balance, and decreased lower extremity strength are common in people with obesity and may negatively affect daily activities and quality of life.
Participants will complete several commonly used clinical functional tests, including the 1-Minute Stair Climbing Test, 40-Meter Fast-Paced Walk Test, 2-Minute Walk Test, Timed Up and Go Test, and 30-Second Sit-to-Stand Test. In addition, cardiopulmonary exercise testing, balance assessment, and knee extensor muscle strength measurements will be performed.
The study will evaluate whether these simple and clinically applicable tests provide reliable results over repeated measurements and whether they are associated with objective indicators of physical function such as maximal oxygen consumption (VO₂max), balance performance, and muscle strength. The findings may help clinicians use practical and cost-effective tools to assess physical function in individuals with obesity.
- Conditions
- Obesity & Overweight
- Being tested
- Physical Performance Tests
- Keywords
- Obesity, Performance test, Balance, Exercise capacity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Performance TestsOther
Participants will undergo a series of standardized performance-based physical function assessments, including the 1-Minute Stair Climbing Test, 40-Meter Fast-Paced Walk Test, 2-Minute Walk Test, Timed Up and Go Test, and 30-Second Sit-to-Stand Test. Each test will be performed twice with standardized rest intervals between assessments. To evaluate test-retest reliability, the same functional tests will be repeated 5-7 days later under identical conditions and in the same order.
In addition to functional testing, participants will complete cardiopulmonary exercise testing (CPET) using the Modified Bruce Protocol to determine maximal oxygen consumption (VO₂max), computerized static and dynamic balance assessments using the PROKIN® system, and knee extensor muscle strength measurements using a hand-held dynamometer. No therapeutic intervention or treatment will be administered during the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Minute Stair Climbing Test
A performance-based functional test used to assess stair climbing ability and lower extremity functional capacity. The total number of completed stair cycles within 1 minute will be recorded.
Measured: 1 hour
40-Meter Fast-Paced Walk Test
A walking performance test used to evaluate fast-paced gait speed and functional mobility. The time required to complete a total walking distance of 40 meters will be measured in seconds.
Measured: 1 hour
2-Minute Walk Test
A functional endurance test used to assess ambulatory capacity. The total walking distance completed within 2 minutes will be recorded in meters.
Measured: 1 hour
Timed Up and Go Test
A functional mobility test used to assess dynamic balance and independent mobility. The time required to stand up from a chair, walk 3 meters, return, and sit down will be measured in seconds.
Measured: 1 hour
30-Second Sit-to-Stand Test
A lower extremity functional strength and endurance test. The total number of sit-to-stand repetitions completed within 30 seconds will be recorded.
Measured: 1 hour
Secondary outcomes (4)
Cardiopulmonary Exercise Testing (VO₂max)
A maximal exercise test performed using the Modified Bruce Protocol on a treadmill to assess aerobic exercise capacity. Maximal oxygen consumption (VO₂max) values will be recorded.
Measured: 1 hour
Static Balance Assessment
Balance performance will be evaluated using the PROKIN® computerized balance assessment system. Parameters related to postural stability and body sway during static tasks will be recorded
Measured: 1 hour
Knee Extensor Muscle Strength
Isometric knee extensor muscle strength will be measured using a hand-held dynamometer. Maximum voluntary contraction force will be recorded.
Measured: 1 hour
Dynamic Balance Assessment
Description: Balance performance will be evaluated using the PROKIN® computerized balance assessment system. Parameters related to postural stability and body sway during static and dynamic tasks will be recorded
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunus Emre Tutuneken
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605793
- Sponsor's protocol ID
- 21
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician-Friendly Physical Performance Tests in Individuals With Obesity: Reliability and Validity
- ClinicalTrials.gov ID
- NCT07605793
- Acronym / sponsor ID
- 21
- Conditions
- Obesity & Overweight
- Keywords
- Obesity, Performance test, Balance, Exercise capacity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Yunus Emre TutunekenUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 26 May 2026 (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.
This study aims to investigate the reliability and validity of practical performance-based physical function tests in individuals with obesity. Functional limitations such as reduced walking ability, impaired balance, and decreased lower extremity strength are common in people with obesity and may negatively affect daily activities and quality of life.
Participants will complete several commonly used clinical functional tests, including the 1-Minute Stair Climbing Test, 40-Meter Fast-Paced Walk Test, 2-Minute Walk Test, Timed Up and Go Test, and 30-Second Sit-to-Stand Test. In addition, cardiopulmonary exercise testing, balance assessment, and knee extensor muscle strength measurements will be performed.
The study will evaluate whether these simple and clinically applicable tests provide reliable results over repeated measurements and whether they are associated with objective indicators of physical function such as maximal oxygen consumption (VO₂max), balance performance, and muscle strength. The findings may help clinicians use practical and cost-effective tools to assess physical function in individuals with obesity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals With Obesity
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥ 30 kg/m²
- Stable body weight during the last 3 months (less than ±2 kg change)
- Ability to perform daily living activities independently
Key exclusion criteria (14 listed)
- History of cardiovascular disease
- History of pulmonary disease
- History of neurological disease
- Musculoskeletal injury affecting lower extremity function
- Presence of lower extremity prosthesis or severe deformity
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 |
|---|---|---|
| Physical Performance TestsParticipants will undergo a series of standardized performance-based physical function assessments, including the 1-Minute Stair Climbing Test, 40-Meter Fast-Paced Walk Test, 2-Minute Walk Test, Timed Up and Go Test, and 30-Second Sit-to-Stand Test. Each test will be performed twice with standardized rest intervals between assessments. To evaluate test-retest reliability, the same functional tests will be repeated 5-7 days later under identical conditions and in the same order. In addition to functional testing, participants will complete cardiopulmonary exercise testing (CPET) using the Modified Bruce Protocol to determine maximal oxygen consumption (VO₂max), computerized static and dynamic balance assessments using the PROKIN® system, and knee extensor muscle strength measurements using a hand-held dynamometer. No therapeutic intervention or treatment will be administered during the study. | Other | – |
Primary outcome
1-Minute Stair Climbing Test
Time frame: 1 hour
A performance-based functional test used to assess stair climbing ability and lower extremity functional capacity. The total number of completed stair cycles within 1 minute will be recorded.
40-Meter Fast-Paced Walk Test
Time frame: 1 hour
A walking performance test used to evaluate fast-paced gait speed and functional mobility. The time required to complete a total walking distance of 40 meters will be measured in seconds.
2-Minute Walk Test
Time frame: 1 hour
A functional endurance test used to assess ambulatory capacity. The total walking distance completed within 2 minutes will be recorded in meters.
Timed Up and Go Test
Time frame: 1 hour
A functional mobility test used to assess dynamic balance and independent mobility. The time required to stand up from a chair, walk 3 meters, return, and sit down will be measured in seconds.
30-Second Sit-to-Stand Test
Time frame: 1 hour
A lower extremity functional strength and endurance test. The total number of sit-to-stand repetitions completed within 30 seconds will be recorded.
4 secondary outcomes
Cardiopulmonary Exercise Testing (VO₂max)
Time frame: 1 hour
Static Balance Assessment
Time frame: 1 hour
Knee Extensor Muscle Strength
Time frame: 1 hour
Dynamic Balance Assessment
Time frame: 1 hour
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 26 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight, run by Yunus Emre Tutuneken.
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 14 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: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Minute Stair Climbing Test (time frame: 1 hour). The study lists 5 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 26 May 2026.