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

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

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

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Flow Restricted Aerobic (BFRA); Low intensity Aerobic exercise with Blood Flow Restriction	Other: Exercise; Aerobic Exercise
Experimental: Moderate Aerobic Exercise (MAE); moderate intensity aerobic exercise	Other: Exercise; Aerobic Exercise

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Aerobic Exercise; Blood Flow Restricted Exercise
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No