Clinical trial NCT06139913: Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus
Official title: Effect of Fat Burning Zone of Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective study
Primary purpose: TREATMENT

Brief summary: In adolescent diabetic girls, a correct life style, including diet and physical activity, is part of a correct intervention protocol. Thus, the aim of this study was to evaluate the effects of aerobic training intervention, based on heart rate at glycemic level , on clinical and physiological parameters in adolescent girls with type 1 diabetes forty type1 DM girls will randomly assigned to an intervention (study group ) or control group. The study group will perform a supervised aerobic exercise training based on heart rate whereas control group maintained their usual lifestyle. Anthropometric fitness score measures, blood analysis will assess at baseline and after intervention.

Detailed description: fourty adolescents girls were diagnosed by physician as having type 1 diabetes mellitus and recruited from outpatient internal of El-Hussien hospital in Egypt . girls ages were between 13 and 18yr old; . The following inclusion criteria was applied to all participants in the study : all girls had type 1DM for more than 3 years, Their dose of insulin intake over 0.4 U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2 . Moderate-intensity aerobic exercise was defined according to the classification standard of the ACSM, which refers to exercise where the HRR of subjects is 64-76%; the moderate-intensity target heart rate area was set in advance and controlled by heart rate monitor during the intervention, and the menarche was began from 3 to 5 years. The patients had no history of severe and frequent hypoglycemia in the last 6 months (\< 60 mg/dl, more than twice a week).

All participants attended a clinic for clinical assessments before and after treatment plane.

1. Body Mass Index (BMI)
2. Fitness score
3. Target Heart Rate
4. Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.
5. Estradiol blood test

Eligibility criteria: Inclusion Criteria:

* All girls had type 1DM for more than 3 years,
* Their didn't of insulin intake over 0.4 U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2

Exclusion Criteria:

* Diabetes as a secondary condition
* Any known cardiac defects and Macrovascular or microvascular chronical complications.
* Insulin therapy and regulate dietary intake Were followed through diabetes physician.

Primary outcomes:
measure: Fitness score:
timeFrame: 3 month
measure: Fasting blood samples, post prandial and HbA1c:
timeFrame: 3 month
measure: Estradiol blood test
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of pysical therapy, MTI university
Study officials:
affiliation: lecturer of pediatric physical therapy
name: karim sami ibrahim, doctoral
role: STUDY_DIRECTOR
References: