The Impact of Frailty in Type 2 Diabetes

Sponsor

Kırıkkale University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05863611

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Days)

72.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Other: arms

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

May 20, 2023

Anticipated Primary Completion Date :

May 25, 2023

Anticipated Study Completion Date :

Jun 10, 2023

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Frailty has an effect on balance in patients with type 2 diabetes. [march 15, 2023 - june 10 , 2023]
Balance assessment will be made with the Tinetti Balance

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulsah Turanoglu	Kırıkkale	Merkez	Turkey	71000

Sponsors and Collaborators

Kırıkkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gulsah Turanoglu, Principal Investigator, Kırıkkale University

ClinicalTrials.gov Identifier:

NCT05863611

Other Study ID Numbers:

KirikkaleUniversity711

First Posted:

May 18, 2023

Last Update Posted:

May 18, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Frailty

Study Results

No Results Posted as of May 18, 2023