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NCT05863611 Clinical Trial

The Impact of Frailty in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:
The Effect of Frailty on Balance and Fall Risk in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05863611
Other study ID # KirikkaleUniversity711
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 20, 2023
Est. completion date June 10, 2023

Study information
Verified date May 2023
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of our work; To investigate the effect of frailty on balance and fall risk in individuals with type 2 diabetes.The reason why participants the investigators invited to the study is participants diagnosis of Type 2 Diabetes.During the research, a questionnaire form (age, gender, educational status, etc.) in which participants demographic information will be recorded for evaluation purposes and a consent form for participation in the study will be filled. Standardized Mini Mental Test will be applied. Then fragility will be evaluated with the Fried Fragility Index. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale and balance assessment will be made with the Tinetti Balance. participants will not need to spend a long time for all assessments. The time required for the assessment will be around 30 minutes.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date June 10, 2023
Est. primary completion date May 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Diagnosed with diabetes - Being 65 years or older - Not having a cooperation problem, - No communication difficulties or problems voluntarily accepting participation in the research Exclusion Criteria: - - Those with uncontrollable hypertension, heart disease, cardiac arrhythmia - Those with cardiovascular disease - Those who have malignancy and cause malignancy, chemotherapy, radiotherapy - Those with any neurological or orthopedic disorders - Those who have had an operation in the last 6 months - Those on bed rest - Individuals addicted to alcohol and drugs - Those who do not agree to participate in the research

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• arms
During the research, a questionnaire form (age, gender, educational status, etc.) in which your demographic information will be recorded for evaluation purposes and a consent form for participation in the study will be filled. Standardized Mini Mental Test will be applied. Then fragility will be evaluated with the Fried Fragility Index. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale. Balance assessment will be made with the Tinetti Balance and Gait Assessment.

Locations
Country Name City State
Turkey Gulsah Turanoglu Kirikkale Merkez

Sponsors (1)
Lead Sponsor Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frailty has an effect on balance in patients with type 2 diabetes. Balance assessment will be made with the Tinetti Balance march 15, 2023 - june 10 , 2023
Secondary Frailty has an effect on the risk of falling in patients with type 2 diabetes. Fall assessment will be assessed with the Fall Risk Self-Assessment Scale march 15, 2023 - june 10 , 2023
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