COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

Diabetes Mellitus Clinical Trial

Official title:

EFFECT OF HIGH VERSUS LOW-VOLUME HIGH INTENSITY INTERVAL TRAINING ON GLYCEMIC AND LIPIDS CONTROL IN TYPE 2 DIABETES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110404
• Other study ID #: P.T.REC/012/002900
• Status: Completed
• Phase: N/A
• Start date: December 25, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• The high-volume HIIT
patients will undergo a warm up at 65%-70% of HRpeak for 5 minutes, and then they will walk on a treadmill for 4 intervals of 4 min each at an intensity corresponding to 85%-90% of HRpeak with 3 min active recovery interval interval in between at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted between intervals to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.
• The low-volume HIIT
Each session will start with a 5-minute warm up at 65-70% of peak HR. Then they will walk on a treadmill for 4 intervals of 2 min each at an intensity corresponding to 85%-90% of HRpeak with three intervals of active recovery in between for 2 min at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body mass index	change in body mass index	12 weeks
Primary	waist circumference	change in waist circumference	12 weeks
Primary	waist/hip ratio	change in waist/hip ratio	12 weeks
Primary	Systolic and diastolic blood pressure	change in Systolic and diastolic blood pressure	12 weeks
Primary	HbA1c	change in HbA1c	12 weeks
Primary	fasting & 2-h post prandial blood glucose	change in fasting & 2-h post prandial blood glucose	12 weeks
Primary	fasting lipid profile	change in fasting lipid profile	12 weeks