The Impact of Frailty in Type 2 Diabetes

May 8, 2023 updated by: Gulsah Turanoglu, Kırıkkale University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Kırıkkale, Merkez, Turkey, 71000
        • Gulsah Turanoglu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

be diagnosed with type 2 diabetes be over 65 years old

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
25 individuals with frailty syndrome with type 2 diabetes
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.
25 individuals without frailty syndrome with type 2 diabetes
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty has an effect on balance in patients with type 2 diabetes.
Time Frame: march 15, 2023 - june 10 , 2023
Balance assessment will be made with the Tinetti Balance
march 15, 2023 - june 10 , 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty has an effect on the risk of falling in patients with type 2 diabetes.
Time Frame: march 15, 2023 - june 10 , 2023
Fall assessment will be assessed with the Fall Risk Self-Assessment Scale
march 15, 2023 - june 10 , 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 20, 2023

Primary Completion (Anticipated)

May 25, 2023

Study Completion (Anticipated)

June 10, 2023

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KirikkaleUniversity711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

march 15,2023 - june 10,2023

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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