Effect of Blood Flow Restricted Aerobic Exercise in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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Comparison of the effect of low intensity blood flow restricted aerobic exercise on glycemic and respiratory status with moderate aerobic exercise.

Detailed Description
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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 .

Official Title
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Investigation of the Effect of Blood Flow Restricted Aerobic Exercise on Cardiorespiratory Fitness and Blood Glucose in Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Flow Restricted Aerobic (BFRA)<br>Low intensity Aerobic exercise with Blood Flow Restriction | Other: Exercise<br>* Aerobic Exercise<br>|
| Experimental: Moderate Aerobic Exercise (MAE)<br>moderate intensity aerobic exercise | Other: Exercise<br>* Aerobic Exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose | Fasting Blood Glucose, this data will be collected from the individulas routine biochemistry tests | up to 12 months | 
| HbA1c | Glycated hemoglobin, This data will be collected from teh individulas during routine test | up to 12 months | 
| 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. | Up to 12 months | 
| Cardiorespiratory Fitness | Maximal Power in Maximal Exercise Test, this test will be performed in incremental cardiopulmonary exercise test in cycle ergometer. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 months | 
| 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. | Up to 12 months | 
| 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. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Flow Restricted Exercise, Type 2 Diabetes, Aerobic Exercise