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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04315519
• Other study ID #: 26
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2020
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: Elif SAHIN
• Phone: +90 (464) 344 20 45
• Email: fztelifsahin61[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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" .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: September 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Exercise
Aerobic Exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose	Fasting Blood Glucose, this data will be collected from the individulas routine biochemistry tests	up to 12 months
Primary	HbA1c	Glycated hemoglobin, This data will be collected from teh individulas during routine test	up to 12 months
Primary	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
Primary	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	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
Secondary	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
Secondary	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