COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: The low-volume HIIT; Other: The high-volume HIIT

• Registration Number: NCT05110404
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-08
• Study Start: 2021-12-25
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
fasting & 2-h post prandial blood glucose	12 weeks	change in fasting \& 2-h post prandial blood glucose
body mass index	12 weeks	change in body mass index
waist circumference	12 weeks	change in waist circumference
waist/hip ratio	12 weeks	change in waist/hip ratio
Systolic and diastolic blood pressure	12 weeks	change in Systolic and diastolic blood pressure
HbA1c	12 weeks	change in HbA1c
fasting lipid profile	12 weeks	change in fasting lipid profile

Trial Locations

Locations (1)

Faculty of Physical Therapy cairo University; 🇪🇬 Cairo, Egypt