COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-25

Study Completion Date

2022-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group (A): 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.

Group Type ACTIVE_COMPARATOR

The high-volume HIIT

Intervention Type OTHER

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.

Group (B): 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 Type ACTIVE_COMPARATOR

The low-volume HIIT

Intervention Type OTHER

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.

Group C

patients will receive medical intervention only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Asmaa Mohamed Mahmoud Mohamed

physiotherapist holds a master's degree in Physical therapy for Cardiovascular, Respiratory disorders and geriatrics, Faculty of physical therapy, Cairo university.

Responsibility Role PRINCIPAL_INVESTIGATOR