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

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Other: Exercise

• Registration Number: NCT04315519
• Lead Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

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" .

Study Timeline

• Study First Submitted: 2020-01-27
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-18
• Last Update Submitted: 2020-03-18
• Study First Posted: 2020-03-19
• Last Update Posted: 2020-03-19
• Study Start: 2020-04-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood Flow Restricted Aerobic (BFRA)	Exercise	Low intensity Aerobic exercise with Blood Flow Restriction
Moderate Aerobic Exercise (MAE)	Exercise	moderate intensity aerobic exercise

Primary Outcome Measures

Name	Time	Method
Blood Glucose	up to 12 months	Fasting Blood Glucose, this data will be collected from the individulas routine biochemistry tests
HbA1c	up to 12 months	Glycated hemoglobin, This data will be collected from teh individulas during routine test
Cardiorespiratory Fitness	Up to 12 months	Maximal Power in Maximal Exercise Test, this test will be performed in incremental cardiopulmonary exercise test in cycle ergometer.
Blood Glucose in Oral glucose Tolerance Test	Up to 12 months	Blood Glucose in Oral glucose Tolerance Test, this data will be collected from the individuals during routine tests.

Secondary Outcome Measures

Name	Time	Method
Fat Free Mass	Up to 12 months	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 Quadriceps Muscle	Up to 12 months	The Strength of Quadriceps Muscle, this data will be collected before the intervention eith a manual muscle tester, in sitting position.
The Strength of Hamstring Muscle	Up to 12 months	The Strength of Hamstring Muscle, this data will be collected before the intervention eith a manual muscle tester, in sitting position.