Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

Completed

• Conditions: Gait Disorder, Sensorimotor; Diabetes Mellitus, Type 2

• Registration Number: NCT04758364
• Lead Sponsor: GULIN FINDIKOGLU

Brief Summary

This study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy.

Detailed Description

Type 2 diabetic people will be screened by clinical symptoms of neuropathy and DN4 questionnaire. Among those who did not have neuropathic symptoms or who have DN4 score below 4 will be considered for the study.Then aerobic capacity will be measured by a cycle ergometer and VO2max will be obtained. Weight, body mass index and muscle mass will be measured by bioimpedance analysis. Physical activity status will be determined by International Physical Activity Score (IPAQ). Cognitive function will be evaluated by Mini Mental test. HbA1c and fasting blood glucose will be measured in venous blood after overnight fasting. Blood pressure will be measured in the sitting position after resting from the left arm. Speed of gait will be measured by an accelerometer.Then, the effect of above mentioned factors on speed of gait will be studied.

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Study Start: 2021-02-20
• Status Verified: 2021-03
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-30
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Individuals with Diabetes Mellitus less than 10 years but longer than 1 year
• Absence of neuropathic symptoms
• DN4 questionnaire sore less than 4

Exclusion Criteria

Individuals who had

• insulin therapy,
• poor glycemic control,
• manifesting cardiovascular disease,
• retinopathy or other visual problems,
• diabetic neuropathy,
• nephropathy,
• cerebrovascular disease,
• cognitive impairment,
• heart failure,
• alcohol or cigarette dependence,
• cancer,
• chemo/radiotherapy,
• foot ulcer,
• orthopedical or surgical problems
• wheel-chair or any assistive devices for ambulation
• prominent knee or hip arthritis, prosthesis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
gait speed	The gait speed will be measured once within a month after the participants enrolled.	gait speed measured by wearable accelerometer

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey