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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04315519
Other study ID # 26
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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