Back to resultsNeuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus
Primary Purpose
Gait, Unsteady, Aerobic Exercise
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Gait, Unsteady focused on measuring Type 2 diabetes mellitus, exercise, aerobic, interval, continuous, gait
Eligibility Criteria
Inclusion Criteria:
- Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
- Participants must have appropriate medical therapy and diet.
- Participants must not be treated with insulin.
- Participants must be exercising less than 210 minutes/ week
Exclusion Criteria:
- Participants with prominent cardiovascular disease
- Participants with coronary artery disease
- Participants with moderate to severe valvular disease
- Participants with atrial fibrillation
- Participants with untreated hypertension
- Participants with congenital heart disease
- Participants with retinopathy
- Participants with neuropathy
- Participants with macro albuminuria
- Participants with cerebrovascular disease
- Participants with ejection fraction less than 40
- Participants with body mass index greater than 35.
- Participants with prominent ischemic changes in EKG at rest or during exercise.
- Participants with cigarette or alcohol addiction
- Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
High intensity interval exercise
Moderate intensity continuous exercise
No Intervention: Control group
Arm Description
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
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
The participants with type 2 Diabetes mellitus in the control group will make stretching exercise at home
Outcomes
Primary Outcome Measures
walking speed
change in walking speed in m/s
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04068285
Brief Title
Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus
Official Title
Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady, Aerobic Exercise
Keywords
Type 2 diabetes mellitus, exercise, aerobic, interval, continuous, gait
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study has 3 arms.
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants wil be making exercise. It is not possible to make participants blinded to the study.
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity interval exercise
Arm Type
Active Comparator
Arm Description
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
Arm Title
Moderate intensity continuous exercise
Arm Type
Active Comparator
Arm Description
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
Arm Title
No Intervention: Control group
Arm Type
No Intervention
Arm Description
The participants with type 2 Diabetes mellitus in the control group will make stretching exercise at home
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
Participants will be making aerobic exercise
Primary Outcome Measure Information:
Title
walking speed
Description
change in walking speed in m/s
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
Participants must have appropriate medical therapy and diet.
Participants must not be treated with insulin.
Participants must be exercising less than 210 minutes/ week
Exclusion Criteria:
Participants with prominent cardiovascular disease
Participants with coronary artery disease
Participants with moderate to severe valvular disease
Participants with atrial fibrillation
Participants with untreated hypertension
Participants with congenital heart disease
Participants with retinopathy
Participants with neuropathy
Participants with macro albuminuria
Participants with cerebrovascular disease
Participants with ejection fraction less than 40
Participants with body mass index greater than 35.
Participants with prominent ischemic changes in EKG at rest or during exercise.
Participants with cigarette or alcohol addiction
Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulin Findikoglu, Assoc Prof
Organizational Affiliation
Pamukkale University,Medical Faculty, PMR Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
21600
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuromuscular Adaptations to Exercise In Patients With Type 2 Diabetes Mellitus
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