Effect of Blood Flow Restricted Aerobic Exercise in Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Blood Flow Restricted Exercise, Type 2 Diabetes, Aerobic Exercise
Eligibility Criteria
Inclusion Criteria:
- Having Type 2 Diabetes
- Not have been recruited any exercise programme for 6 months
- Volunteering to participate in the study
Exclusion Criteria:
- Nephropathy
- Retinopathy
- Have had myocardial infarction at least 6 months ago
- Stable or unstable angina pectoris
- The presence of peripheral artery disease
- Resting blood pressure above 160/100 mmHg
- Body mass index over 35 kg / m2
- History of deep vein thrombosis, pulmonary embolism or stroke
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Blood Flow Restricted Aerobic (BFRA)
Moderate Aerobic Exercise (MAE)
Arm Description
Low intensity Aerobic exercise with Blood Flow Restriction
moderate intensity aerobic exercise
Outcomes
Primary Outcome Measures
Blood Glucose
Fasting Blood Glucose, this data will be collected from the individulas routine biochemistry tests
HbA1c
Glycated hemoglobin, This data will be collected from teh individulas during routine test
Blood Glucose in Oral glucose Tolerance Test
Blood Glucose in Oral glucose Tolerance Test, this data will be collected from the individuals during routine tests.
Cardiorespiratory Fitness
Maximal Power in Maximal Exercise Test, this test will be performed in incremental cardiopulmonary exercise test in cycle ergometer.
Secondary Outcome Measures
The Strength of Quadriceps Muscle
The Strength of Quadriceps Muscle, this data will be collected before the intervention eith a manual muscle tester, in sitting position.
Fat Free Mass
Fat Free Mass will be calculated by bioimpedance analysis, this data will be collected with all individulas to see the changes with the muscle mass, the test will be The test will be carried out with a 4-channel test device, both hand and foot, to eveluate changes segmentally.
The Strength of Hamstring Muscle
The Strength of Hamstring Muscle, this data will be collected before the intervention eith a manual muscle tester, in sitting position.
Full Information
NCT ID
NCT04315519
First Posted
January 27, 2020
Last Updated
March 18, 2020
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04315519
Brief Title
Effect of Blood Flow Restricted Aerobic Exercise in Type 2 Diabetes Mellitus
Official Title
Investigation of the Effect of Blood Flow Restricted Aerobic Exercise on Cardiorespiratory Fitness and Blood Glucose in Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
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
Comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise.
Detailed Description
The aim of this study is to show, whether the effect of low-intensity aerobic exercise training combined with blood flow restriction is similar on both glycemic and cardiorespiratory status compared to moderate-intensity continuous aerobic exercise, in individuals with "type 2 diabetes mellitus" .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Blood Flow Restricted Exercise, Type 2 Diabetes, Aerobic Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood Flow Restricted Aerobic (BFRA)
Arm Type
Experimental
Arm Description
Low intensity Aerobic exercise with Blood Flow Restriction
Arm Title
Moderate Aerobic Exercise (MAE)
Arm Type
Experimental
Arm Description
moderate intensity aerobic exercise
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Aerobic Exercise
Primary Outcome Measure Information:
Title
Blood Glucose
Description
Fasting Blood Glucose, this data will be collected from the individulas routine biochemistry tests
Time Frame
up to 12 months
Title
HbA1c
Description
Glycated hemoglobin, This data will be collected from teh individulas during routine test
Time Frame
up to 12 months
Title
Blood Glucose in Oral glucose Tolerance Test
Description
Blood Glucose in Oral glucose Tolerance Test, this data will be collected from the individuals during routine tests.
Time Frame
Up to 12 months
Title
Cardiorespiratory Fitness
Description
Maximal Power in Maximal Exercise Test, this test will be performed in incremental cardiopulmonary exercise test in cycle ergometer.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
The Strength of Quadriceps Muscle
Description
The Strength of Quadriceps Muscle, this data will be collected before the intervention eith a manual muscle tester, in sitting position.
Time Frame
Up to 12 months
Title
Fat Free Mass
Description
Fat Free Mass will be calculated by bioimpedance analysis, this data will be collected with all individulas to see the changes with the muscle mass, the test will be The test will be carried out with a 4-channel test device, both hand and foot, to eveluate changes segmentally.
Time Frame
Up to 12 months
Title
The Strength of Hamstring Muscle
Description
The Strength of Hamstring Muscle, this data will be collected before the intervention eith a manual muscle tester, in sitting position.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having Type 2 Diabetes
Not have been recruited any exercise programme for 6 months
Volunteering to participate in the study
Exclusion Criteria:
Nephropathy
Retinopathy
Have had myocardial infarction at least 6 months ago
Stable or unstable angina pectoris
The presence of peripheral artery disease
Resting blood pressure above 160/100 mmHg
Body mass index over 35 kg / m2
History of deep vein thrombosis, pulmonary embolism or stroke
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif SAHIN
Phone
+90 (464) 344 20 45
Email
fztelifsahin61@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Blood Flow Restricted Aerobic Exercise in Type 2 Diabetes Mellitus
We'll reach out to this number within 24 hrs