Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus

June 2, 2020 updated by: GULIN FINDIKOGLU, Pamukkale University
The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on basic gait parameters in patients with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with basic gait parameters such as cadence, gait speed, stride length, percentages of swing phase and stance phase evaluated by a wireless digital miniature gait analysis system.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
  2. Participants must have appropriate medical therapy and diet.
  3. Participants must not be treated with insulin.
  4. Participants must be exercising less than 210 minutes/ week

Exclusion Criteria:

  1. Participants with prominent cardiovascular disease
  2. Participants with coronary artery disease
  3. Participants with moderate to severe valvular disease
  4. Participants with atrial fibrillation
  5. Participants with untreated hypertension
  6. Participants with congenital heart disease
  7. Participants with retinopathy
  8. Participants with neuropathy
  9. Participants with macro albuminuria
  10. Participants with cerebrovascular disease
  11. Participants with ejection fraction less than 40
  12. Participants with body mass index greater than 35.
  13. Participants with prominent ischemic changes in EKG at rest or during exercise.
  14. Participants with cigarette or alcohol addiction
  15. Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High intensity interval exercise

Participants with type 2 Diabetes mellitus in High intensity interval exercise (HIIE) group will make aerobic exercise using bicycle at high intensity followed by low intensity periods under observation in the hospital.

exercise
Other: Aerobic Exercise
Participants will be making aerobic exercise
Active Comparator: Moderate intensity continuous exercise

Participants with type 2 Diabetes mellitus in Moderate intensity continuous exercise (MIC) group will make aerobic exercise using bicycle at moderate intensity during the session under observation in the hospital.

exercise
Other: Aerobic Exercise
Participants will be making aerobic exercise
No Intervention: No Intervention: Control group
The participants with type 2 Diabetes mellitus in the control group will make stretching exercise at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
walking speed
Time Frame: 12 weeks
change in walking speed in m/s
12 weeks

Collaborators and Investigators

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

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Gulin Findikoglu, Assoc Prof, Pamukkale University,Medical Faculty, PMR Department

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)

November 4, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60116787-0

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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