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Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068285
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
GULIN FINDIKOGLU, Pamukkale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gait, Unsteady Aerobic Exercise Other: Aerobic Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study has 3 arms.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants wil be making exercise. It is not possible to make participants blinded to the study.
Primary Purpose: Supportive Care
Official Title: Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : November 4, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. walking speed [ Time Frame: 12 weeks ]
    change in walking speed in m/s



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068285


Locations
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Turkey
Pamukkale University
Denizli, Turkey, 21600
Sponsors and Collaborators
Pamukkale University
Investigators
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Principal Investigator: Gulin Findikoglu, Assoc Prof Pamukkale University,Medical Faculty, PMR Department
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Responsible Party: GULIN FINDIKOGLU, Associate Professor, Pamukkale University
ClinicalTrials.gov Identifier: NCT04068285    
Other Study ID Numbers: 60116787-0
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GULIN FINDIKOGLU, Pamukkale University:
Type 2 diabetes mellitus
exercise
aerobic
interval
continuous
gait
Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms