COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

Cairo University (CU)

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: The high-volume HIIT; Other: The low-volume HIIT

Study type: Interventional

Funder types: Other

Identifiers

NCT05110404

P.T.REC/012/002900

Details and patient eligibility

About

Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes. The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however, little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid control in these patients. Therefore, the purpose of this study is to compare between two subtypes of HIIT (i.e. the low-volume HIIT versus the high-volume HIIT) with respect to exercise-induced changes in blood glucose, lipid profile and anthropometry in patients with type 2 diabetes mellitus. Statement of the Problem Is there any difference between the effect of high-volume and the low-volume high intensity interval training on glycemic and lipids control in type 2 diabetes?

Purpose of the study:

To assess the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.

Null Hypothesis:

There will be no difference between the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.

Enrollment: 72 patients

Sex: Female

Ages: 35 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type II diabetes mellitus diagnosed by a physician as having HbA 1c of > 6.5%.
2. An established diagnosis of T2DM for at least 1year and less than 5 years.
3. Women patients.
4. Age between 35 to 45 years old.
5. Systolic Blood pressure less than or equal 130 mmHg.
6. Obese patients (BMI is between 30 and 39.9 kg/m 2 )
7. Patients with HbA 1c of 7-9%.
8. A self-reported sedentary lifestyle.
9. Patients receiving oral hypoglycemic medications described by the physician
10. Patients with hyperlipidemia.

Exclusion criteria

1. Patients with Cardiac diseases.

2. Patients with glaucoma.

3. Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).

4. Musculoskeletal or neurological limitations to physical exercise.

5. Pregnancy

6. Patients under insulin therapy

7. Patients with poorly controlled DM (HbA1c > 9%)

8. Bronchial asthma and chronic obstructive pulmonary disease.

9. Smokers.

10. Morbidly obese BMI ≥ 40 kg/m 2

11. Males.

12. Systolic Blood pressure more than 130 mmHg. 12. Anemia ( hemoglobin < 12 g/dL) 13. Osteopenia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups

Group (A): The high-volume HIIT

Active Comparator group

Description:

Exercise group A (n=30): It will include patients that will perform high-volume high-intensity interval training (HIIT), and will receive medical intervention.

Treatment:

Other: The high-volume HIIT

Group (B): The low-volume HIIT

Active Comparator group

Description:

Exercise group B (n=30): will receive medical intervention. that will perform the low-volume high-intensity interval training, and will receive medical intervention.

Treatment:

Other: The low-volume HIIT

Group C

No Intervention group

Description:

patients will receive medical intervention only.