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

NCT06139913 | Completed

• 1 other identifier: REC/2111/MTI.PT2303124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Fitness score:

  2- Fitness score: were assessed by multifrequency bioelectrical impedance analysis (MF-BIA; InBody 3.0, Biospace, Seoul, Korea)

  3 month

• Fasting blood samples, post prandial and HbA1c:

  Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.

  3 month

• Estradiol blood test

  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

  3 month

Study Arms (1)

aerobic exercise

EXPERIMENTAL

aerobic exercise using treadmill

Other: aerobic exercise

Interventions

aerobic exercise OTHER

moderate intensity aerobic exercise using treadmill

aerobic exercise

Eligibility Criteria

• Age: 13 Years - 18 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

faculty of pysical therapy, MTI university

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• karim sami ibrahim, doctoral

  lecturer of pediatric physical therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric physical therapy in MTIU

Model Details: prospective study

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: March 15, 2023
• Primary Completion: June 20, 2023
• Study Completion: September 17, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)