COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

NCT05110404 | Completed

• 1 other identifier: P.T.REC/012/002900
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

DM

Outcome Measures

Primary Outcomes (7)

• body mass index

  change in body mass index

  12 weeks

• waist circumference

  change in waist circumference

  12 weeks

• waist/hip ratio

  change in waist/hip ratio

  12 weeks

• Systolic and diastolic blood pressure

  change in Systolic and diastolic blood pressure

  12 weeks

• HbA1c

  change in HbA1c

  12 weeks

• fasting & 2-h post prandial blood glucose

  change in fasting \& 2-h post prandial blood glucose

  12 weeks

• fasting lipid profile

  change in fasting lipid profile

  12 weeks

Study Arms (3)

Group (A): The high-volume HIIT

ACTIVE COMPARATOR

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

Other: The high-volume HIIT

Group (B): The low-volume HIIT

ACTIVE COMPARATOR

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

Other: The low-volume HIIT

Group C

NO INTERVENTION

patients will receive medical intervention only.

Interventions

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.

Group (A): The high-volume HIIT

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.

Group (B): The low-volume HIIT

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy cairo University

Cairo, Egypt

Location

Related Publications (1)

• Ahmad AM, Mahmoud AM, Serry ZH, Mohamed MM, Abd Elghaffar HA. Effects of low-versus high-volume high-intensity interval training on glycemic control and quality of life in obese women with type 2 diabetes. A randomized controlled trial. J Exerc Sci Fit. 2023 Oct;21(4):395-404. doi: 10.1016/j.jesf.2023.08.003. Epub 2023 Aug 30.

  PMID: 37954548 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist holds a master's degree in Physical therapy for Cardiovascular, Respiratory disorders and geriatrics, Faculty of physical therapy, Cairo university.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 8, 2021
• Study Start: December 25, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

EG (1)