Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus

NCT ID: NCT06139913

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-09-17

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

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aerobic exercise

aerobic exercise using treadmill

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: OTHER

moderate intensity aerobic exercise using treadmill

Interventions

aerobic exercise

moderate intensity aerobic exercise using treadmill

Intervention Type: OTHER

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

Rana Nabil Hussein Mohamed

Lecturer of pediatric physical therapy in MTIU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

karim sami ibrahim, doctoral

Role: STUDY_DIRECTOR

lecturer of pediatric physical therapy

Locations

faculty of pysical therapy, MTI university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

REC/2111/MTI.PT2303124

Identifier Type: -

Identifier Source: org_study_id