ClinicalTrials.gg
CompletedNCT06616805Updated Sep 27, 2024

Effect of High Intensity Interval Versus Moderate Intensity Continuous Training on Microalbuminurea

An interventional study of treadmill in Diabetic Nephropathies, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-09-27.

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

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2024, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
All
01

Study summary

purpose: to investigate the effect of low-volume high-intensity interval training and moderate- intensity continuous training on microalbuminuria in patients with diabetic nephropathy. methods: forty patients with microalbuminurea will be recruited and randomly assigned to two groups, group A and group B. patients in group A will receive low-volume HIIT and patients in group B will receive MICT. All patients will be evaluated pre and post treatment for laboratory investigation for ( HBa1c, ACR),and blood pressure.

Read the detailed description
  1. procedures for evaluation: the practical part of the study will be undertaken in 12 weeks(3 sessions a week).measurement will be taken before the start of treatment program then after the end of 12 weeks treatment program in the following manner:

    1. Anthropometric measures: body mass index (BMI) in kg/m2, waist circumference.
    2. Blood pressure measurement: Systolic and diastolic blood pressure.
    3. Biochemical (Lab) analysis:HbA1c, Urinary albumin test (Albumin/Creatinine ratio).
    4. Treadmill Graded exercise test:(Modified Bruce protocol) It will be used before starting of exercise sessions to determine maximum heart rate reached during this test and to predict individualized training target heart rate and training intensity for each patient before training.
  2. Treatment procedures: All subjects in the exercise groups A\&B will perform the exercise interventions using a treadmill 3 sessions per week for 12 weeks. In the early beginning, patients in all groups will receive an educational session about dietary guidelines for type 2 diabetes.

Group (A): low-volume High Intensity Interval Training Patients in this group will undergo a warm-up at low intensity for 10 minutes, and then they will perform a single bout protocol that consisted of 1×4 min at 80-90% HRmax. Finally, a 5-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.

Group (B): Moderate Intensity Continuous Training Each session will start with a 10-minute warm-up at low intensity. Then they will walk on a treadmill for 30 min at moderate intensity corresponding to 65-75% of HR-max. Finally, a 5-min cool-down period will be permitted.

02

Conditions studied

  • Diabetic Nephropathies
03

In context

Diabetic Nephropathies

544 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 385 interventional studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 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
40 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- 1. Type II diabetes mellitus 2. Age between 40 to 55 years old. 3. Blood pressure less than or equals 160/100 mmHg. 4. Patients receiving oral hypoglycemic. 5. Increased urinary albumin excretion (UAE)in the absence of other renal diseases.

6. Microalbuminuria (UAE >30µg /min and \<299µg /min)

Exclusion criteria

Exclusion Criteria:

  • 1. Patients with Cardiac diseases. 2. Patients with chest diseases (Bronchial asthma and chronic obstructive pulmonary disease).

    3. Patients with severe self-limiting illness(cancer). 4. Musculoskeletal or neurological limitations to physical exercise. 5. Patients using insulin therapy. 6. Patients with poorly controlled DM (HbA1c > 9%). 7. Systolic Blood pressure more than 160 mmHg. 8. Morbid obesity. 9. Severe neuropathy. 10. PAD (claudication). 11. Retinopathy (moderate /advanced).

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    low-volume High Intensity Interval Training

    Group (A): low-volume High Intensity Interval Training Patients in this group will undergo a warm-up at low intensity for 10 minutes, and then they will perform a single bout protocol that consisted of 1×4 min at 80-90% HRmax. Finally, a 5-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.

    Device: treadmill

  • Experimental
    Moderate Intensity Continuous Training

    Group (B): Moderate Intensity Continuous Training Each session will start with a 10-minute warm-up at low intensity. Then they will walk on a treadmill for 30 min at moderate intensity corresponding to 65-75% of HR-max. Finally, a 5-min cool-down period will be permitted

    Device: treadmill

Interventions

  • Devicetreadmill

    Treadmill JAGUAR treadmill:( T900, China) motorized treadmill model (T900) motor power (6.OHP) input voltage (AC220-240 V, 50Hz) speed range (1-20KM/H), inclination range (1-15%) was used for exercise treatment

06

What researchers measure

Primary outcomes

  1. albumin/creatinine ratio

    Random urine samples will be collected from patients before and after the end of treatment sessions for measuring al/Cr ratio

    Time frame: change in 12 weeks

  2. Glycated hemoglobin

    blood samples will be collected from patients before and after the end of treatment sessions for measuring HBA1C

    Time frame: change in 12 weeks

Secondary outcomes

  1. blood pressure

    Mercury sphygmomanometer (ALPK2, Japan) was used to measure systolic and diastolic blood pressure before exercise and after the end of treatment sessions

    Time frame: change in 12 weeks

07

Study locations

1 site
  • faculty of physical therapy, Cairo University
    Giza, Cairo Governorate 11432, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Jul 2024, 6 months.

Of 50 non-industry interventional studies with no phase under Diabetic Nephropathies, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 6 months is below that.

Counting every sponsor, half of 53 studies reached it within 23 months; a quarter within 10 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2024
First posted
Sep 27, 2024
StartActual
Jan 1, 2024
Primary completionActual
Jul 29, 2024
CompletionActual
Aug 30, 2024
Last update
Sep 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06616805
Lead sponsor
Cairo University
Responsible party
Nourhan Mohamed Ali Hussein (Demonstrator, Cairo University) — Principal investigator
First posted
Sep 27, 2024
Start date
Jan 1, 2024
Primary completion
Jul 29, 2024
Completion
Aug 30, 2024
Last update
Sep 27, 2024

Study contacts

Heba Ali Abd El Ghafar, A.professor
study director · Cairo University

Oversight

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

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