CClinicalTrials.gg
Sign In
CompletedNCT05110404Updated Feb 22, 2023

COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING

An interventional study of The high-volume HIIT and The low-volume HIIT in Diabetes Mellitus, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus

Keywords

  • DM
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
  1. Systolic Blood pressure more than 130 mmHg. 12. Anemia ( hemoglobin \< 12 g/dL) 13. Osteopenia.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • 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

  • Active comparator
    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.

    Other: The low-volume HIIT

  • No intervention
    Group C

    patients will receive medical intervention only.

Interventions

  • OtherThe 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.

  • OtherThe 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.

06

What researchers measure

Primary outcomes

  1. body mass index

    change in body mass index

    Time frame: 12 weeks

  2. waist circumference

    change in waist circumference

    Time frame: 12 weeks

  3. waist/hip ratio

    change in waist/hip ratio

    Time frame: 12 weeks

  4. Systolic and diastolic blood pressure

    change in Systolic and diastolic blood pressure

    Time frame: 12 weeks

  5. HbA1c

    change in HbA1c

    Time frame: 12 weeks

  6. fasting & 2-h post prandial blood glucose

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

    Time frame: 12 weeks

  7. fasting lipid profile

    change in fasting lipid profile

    Time frame: 12 weeks

07

Study locations

1 site
  • Faculty of Physical Therapy cairo University
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05110404
Lead sponsor
Cairo University
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) — Principal investigator
First posted
Nov 8, 2021
Start date
Dec 25, 2021
Primary completion
Apr 30, 2022
Completion
May 30, 2022
Last update
Feb 22, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Cairo University

Start the discussion