Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

March 30, 2021 updated by: GULIN FINDIKOGLU
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

71

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
      • Denizli, Turkey, 21600
        • Pamukkale University

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Type 2 Diabetic individuals without neuropathy

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gait speed
Time Frame: The gait speed will be measured once within a month after the participants enrolled.
gait speed measured by wearable accelerometer
The gait speed will be measured once within a month after the participants enrolled.

Collaborators and Investigators

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

Sponsor

GULIN FINDIKOGLU

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 (Actual)

February 20, 2021

Primary Completion (Actual)

March 12, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60116787-020/75097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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