Diabetes MellitusNCT07234513
Diabetes Mellitus Symptoms Related to Physical Competence
An observational study of Diabetes Mellitus, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The research is a cross-sectional study and was planned to determine which diabetes mellitus symptoms related to physical competence have a greater impact on balance in patients with diabetes mellitus Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2018to 7 Jul 2025
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Diabetes Mellitus
Who may be able to join
- having Diabetes MEllitus
- having a Mini Mental Test (MMT) score ≥ 24
Who cannot join
- the presence of comorbid conditions that could affect balance, such as lower extremity injuries, musculoskeletal surgery, diabetic neuropathy, orthopedic, neurological and cardiovascular diseases, and hearing or vision problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes Mellitus Symptoms Related to Physical Competence: Do They Predict Dynamic Balance?
The research is a cross-sectional study and was planned to determine which diabetes mellitus symptoms related to physical competence have a greater impact on balance in patients with diabetes mellitus
Read the detailed description
The present study was designed as a cross-sectional observational study to investigate the relationship between diabetes mellitus (DM)-related symptoms and physical competence, with a specific focus on balance performance in individuals diagnosed with DM. Considering that diabetes is a chronic metabolic disease that frequently leads to multisystemic complications such as peripheral neuropathy, muscle weakness, sensory impairments, and reduced physical capacity, it is essential to determine how these clinical manifestations affect functional outcomes. Since balance is a critical component of daily living activities and directly influences fall risk, mobility, and quality of life, identifying which DM-related symptoms most strongly contribute to balance impairment may provide important insights for rehabilitation and preventive strategies. By assessing symptom domains related to physical competence and their association with balance performance, this study aims to reveal the key determinants of postural control in patients with DM, thereby guiding both clinical evaluation and individualized intervention programs.
- Conditions
- Diabetes Mellitus
- Being tested
- There will be no intervention in the study. Only descriptive tests will be used.
- Keywords
- Diabetes Mellitus, Dynamic Balance, Physical Activity, Exertion, Urinary Incontinence
- Medical subject headings
- Diabetes Mellitus, Motor Activity, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There will be no intervention in the study. Only descriptive tests will be used.Diagnostic test
There will be no intervention in the study. Only descriptive tests will be used.
| Study group | Role | What they receive |
|---|---|---|
| 1 | There will be only one group in the study. Receives: Diagnostic Test: There will be no intervention in the study. Only descriptive tests will be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance
Four-Step Square Test (FSST): Two strips were placed perpendicular to each other on the floor to create 4 squares. At the start of the test, the patient stood on square 1 facing square 2. The stepping sequence was as follows: 2-3-4-1-4-3-2-1. Participants were instructed to complete the sequence as fast as possible, without touching the canes or strips, and to ensure that both feet fully contacted the ground in each square. If the participant failed to complete the sequence correctly, lost balance, or touched the cane, the test was repeated. The total time required to complete the test was recorded
Measured: 7 months
Secondary outcomes (4)
International Physical Activity Questionnaire-Long Form (IPAQ-LF)
The IPAQ-LF consists of 27 items designed to assess physical activity across various domains, such as of housework, gardening, work activities, transportation, and leisure activities. The weekly physical activity level was calculated as metabolic equivalent of task (MET), by multiplying the activity duration in the previous week. An increase in the score indicates a high level of physical activity. According to the results, participants can be classified as inactive, minimally active, or very active.
Inactive (Category 1): The lowest level of physical activity. Situations that do not meet the criteria for Categories 2 or 3 are considered "inactive."
Minimally Active (Category 2): Achieving a minimum of 600 MET-min/week, with vigorous activity performed for at least 20 minutes per day on 3 or more days.
Very Active (Category 3): At least 3 days of vigorous activity achieving a minimum of 1500 MET-min/week.
Measured: 7 months
6-Minute Walking Test (6MWT)
6-Minute Walking Test (6MWT): The 6MWT is a valid, reliable, and gold standard maximal exercise effort test, that evaluates functional capacity and aerobic efficiency. The 6MWT was performed between two cones placed 30 m apart. Before the test, the physiotherapist recorded the vital signs (blood pressure, heart rate and respiratory rate per minute). The participants were asked to walk as fast as possible for 6 min and were informed in the last 1 min. If the patient had to stop walking within 6 min, they were asked to lean against the wall, but no patient stopped walking. The assessments were repeated at the end of the 6MWT, and the walking distance was recorded in meters.
Measured: 7 months
Modified Borg Scale (MBS)
Modified Borg Scale (MBS): The MBS is a modified version of the Borg Rating of Perceived Exertion Scale, which was developed to quantify the subjective level of effort experienced during physical activity. The scale is commonly used in clinical rehabilitation to quantify the rates of fatigue-related perceived exertion between 0 and 10. "0" equates to "at rest" and "10" equates to "very, very hard".
Measured: 7 months
International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF)
International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF): The ICIQ-UI SF, consisting of 6 items questioning the frequency, amount, and duration of urinary incontinence, and the impact of these complaints on daily life. The ICIQ-UI SF, is a short and simple questionnaire, that is useful in screening incontinence and obtaining brief but comprehensive data on the level, impact, and perceived effects of incontinence symptoms. The highest possible score on the questionnaire is 21. A higher score indicates a greater impact of incontinence.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start3 Dec 2018
- Primary completion13 Jul 2019
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Mehmet Duray, Suleyman Demirel University
- Investigators
- ÇETİŞLİ KORKMAZ, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234513
- Sponsor's protocol ID
- 60116787-020/71477
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Mellitus Symptoms Related to Physical Competence: Do They Predict Dynamic Balance?
- ClinicalTrials.gov ID
- NCT07234513
- Acronym / sponsor ID
- 60116787-020/71477
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Dynamic Balance, Physical Activity, Exertion, Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 13 Jul 2019 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 18 Nov 2025 (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.
The research is a cross-sectional study and was planned to determine which diabetes mellitus symptoms related to physical competence have a greater impact on balance in patients with diabetes mellitus
Detailed description
The present study was designed as a cross-sectional observational study to investigate the relationship between diabetes mellitus (DM)-related symptoms and physical competence, with a specific focus on balance performance in individuals diagnosed with DM. Considering that diabetes is a chronic metabolic disease that frequently leads to multisystemic complications such as peripheral neuropathy, muscle weakness, sensory impairments, and reduced physical capacity, it is essential to determine how these clinical manifestations affect functional outcomes. Since balance is a critical component of daily living activities and directly influences fall risk, mobility, and quality of life, identifying which DM-related symptoms most strongly contribute to balance impairment may provide important insights for rehabilitation and preventive strategies. By assessing symptom domains related to physical competence and their association with balance performance, this study aims to reveal the key determinants of postural control in patients with DM, thereby guiding both clinical evaluation and individualized intervention programs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: There will be no intervention in the study. Only descriptive tests will be used.There will be only one group in the study. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Diabetes Mellitus
Key inclusion criteria (2 listed)
- having Diabetes MEllitus
- having a Mini Mental Test (MMT) score ≥ 24
Key exclusion criteria (1 listed)
- the presence of comorbid conditions that could affect balance, such as lower extremity injuries, musculoskeletal surgery, diabetic neuropathy, orthopedic, neurological and cardiovascular diseases, and hearing or vision problems.
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 |
|---|---|---|
| There will be no intervention in the study. Only descriptive tests will be used.There will be no intervention in the study. Only descriptive tests will be used. | Diagnostic test | 1 |
Primary outcome
Dynamic balance
Time frame: 7 months
Four-Step Square Test (FSST): Two strips were placed perpendicular to each other on the floor to create 4 squares. At the start of the test, the patient stood on square 1 facing square 2. The stepping sequence was as follows: 2-3-4-1-4-3-2-1. Participants were instructed to complete the sequence as fast as possible, without touching the canes or strips, and to ensure that both feet fully contacted the ground in each square. If the participant failed to complete the sequence correctly, lost balance, or touched the cane, the test was repeated. The total time required to complete the test was recorded
4 secondary outcomes
International Physical Activity Questionnaire-Long Form (IPAQ-LF)
Time frame: 7 months
6-Minute Walking Test (6MWT)
Time frame: 7 months
Modified Borg Scale (MBS)
Time frame: 7 months
International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF)
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
ÇETİŞLİ KORKMAZ study director
Pamukkale University
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 Diabetes Mellitus, run by Suleyman Demirel 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 18 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dynamic balance (time frame: 7 months). 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 18 Nov 2025.