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NCT Number: NCT05110404

COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

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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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with Cardiac diseases.
  • Patients with glaucoma.
  • Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).
  • Musculoskeletal or neurological limitations to physical exercise.
  • Pregnancy
  • Patients under insulin therapy
  • Patients with poorly controlled DM (HbA1c > 9%)
  • Bronchial asthma and chronic obstructive pulmonary disease.
  • Smokers.
  • Morbidly obese BMI ≥ 40 kg/m 2
  • Males.
  • Systolic Blood pressure more than 130 mmHg. 12. Anemia ( hemoglobin < 12 g/dL) 13. Osteopenia.

Treatment and study plan

The high-volume HIIT

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.

The low-volume HIIT

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.

Primary outcomes

  1. body mass index

    Time frame: 12 weeks

    change in body mass index

  2. waist circumference

    Time frame: 12 weeks

    change in waist circumference

  3. waist/hip ratio

    Time frame: 12 weeks

    change in waist/hip ratio

  4. Systolic and diastolic blood pressure

    Time frame: 12 weeks

    change in Systolic and diastolic blood pressure

  5. HbA1c

    Time frame: 12 weeks

    change in HbA1c

  6. fasting & 2-h post prandial blood glucose

    Time frame: 12 weeks

    change in fasting & 2-h post prandial blood glucose

  7. fasting lipid profile

    Time frame: 12 weeks

    change in fasting lipid profile

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2021
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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