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

Sponsor

MTI University (Other)

Overall Status

Completed

CT.gov ID

NCT06139913

Collaborator

(none)

Enrollment

Location

Arm

6.1

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Other: aerobic exercise	N/A

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective studyprospective study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Fat Burning Zone of Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus

Actual Study Start Date :

Mar 15, 2023

Actual Primary Completion Date :

Jun 20, 2023

Actual Study Completion Date :

Sep 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: aerobic exercise aerobic exercise using treadmill	Other: aerobic exercise moderate intensity aerobic exercise using treadmill

Arm

Intervention/Treatment

Experimental: aerobic exercise

aerobic exercise using treadmill

Other: aerobic exercise

moderate intensity aerobic exercise using treadmill

Outcome Measures

Primary Outcome Measures

Fitness score: [3 month]
2- Fitness score: were assessed by multifrequency bioelectrical impedance analysis (MF-BIA; InBody 3.0, Biospace, Seoul, Korea)
Fasting blood samples, post prandial and HbA1c: [3 month]
Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.
Estradiol blood test [3 month]
Estradiol blood test of the participants was done by a laboratory assistant to evaluate the estrogen level of the participants' pre- and post-exercise intervention. The serum concentrations of estradiol (E2) were analyses were performed on day 3 after onset of menstruation

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of pysical therapy, MTI university	Cairo		Egypt

Sponsors and Collaborators

MTI University

Investigators

Study Director: karim sami ibrahim, doctoral, lecturer of pediatric physical therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rana Nabil Hussein Mohamed, Lecturer of pediatric physical therapy in MTIU, MTI University

ClinicalTrials.gov Identifier:

NCT06139913

Other Study ID Numbers:

REC/2111/MTI.PT2303124

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 18, 2023