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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
Recep Tayyip Erdogan University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 27, 2020
    Last Updated
    March 18, 2020
    Sponsor
    Recep Tayyip Erdogan University Training and Research Hospital
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    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

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

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