- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07234513
Diabetes Mellitus Symptoms Related to Physical Competence
Diabetes Mellitus Symptoms Related to Physical Competence: Do They Predict Dynamic Balance?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Isparta, Turkey (Türkiye), 32200
- Suleyman Demirel University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- having Diabetes MEllitus
- having a Mini Mental Test (MMT) score ≥ 24
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1
There will be only one group in the study.
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There will be no intervention in the study.
Only descriptive tests will be used.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dynamic balance
Time Frame: 7 months
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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
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7 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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International Physical Activity Questionnaire-Long Form (IPAQ-LF)
Time Frame: 7 months
|
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. |
7 months
|
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6-Minute Walking Test (6MWT)
Time Frame: 7 months
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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.
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7 months
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Modified Borg Scale (MBS)
Time Frame: 7 months
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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".
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7 months
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International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF)
Time Frame: 7 months
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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.
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7 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: ÇETİŞLİ KORKMAZ, Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Metabolic Diseases
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Glucose Metabolism Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Urinary Incontinence
- Diabetes Mellitus
- Motor Activity
Other Study ID Numbers
- 60116787-020/71477
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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