COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05110404

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Other: The high-volume HIIT Other: The low-volume HIIT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Active Comparator: Group (B): The low-volume HIIT

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

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.

Outcome Measures

Primary Outcome Measures

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 & 2-h post prandial blood glucose [12 weeks]
change in fasting & 2-h post prandial blood glucose
fasting lipid profile [12 weeks]
change in fasting lipid profile

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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., Cairo University

ClinicalTrials.gov Identifier:

NCT05110404

Other Study ID Numbers:

P.T.REC/012/002900

First Posted:

Nov 8, 2021

Last Update Posted:

Nov 8, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by 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., Cairo University

Study Results

No Results Posted as of Nov 8, 2021