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Effect of Aerobic Exercises and Nutrition In Adolescent Girls With Anorexia

Primary Purpose

Anorexia in Adolescence

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

aerobic exercises + Diet

diet proram

About this trial

This is an interventional treatment trial for Anorexia in Adolescence focused on measuring anorexia, adolescent girls, areobic exercises

Eligibility Criteria

14 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Thirty girls with anorexia
BMI ≤ 18 kg/m2
Age ranged from (14-17 years).

Exclusion Criteria:

Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.

Sites / Locations

Badr UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

DIET PROGRAM IN ADDITION TO AEROBIC EXRCISES

DIET PROGRAM

Outcomes

Primary Outcome Measures

Estradiol level

blood test

Secondary Outcome Measures

Full Information

NCT ID

NCT05057000

First Posted

September 13, 2021

Last Updated

January 1, 2022

Sponsor

Badr University

1. Study Identification

Unique Protocol Identification Number

NCT05057000

Brief Title

Effect of Aerobic Exercises and Nutrition In Adolescent Girls With Anorexia

Official Title

Effect of Aerobic Exercises and Nutrition on The Activities of Daily Living and Estrogen Level in Adolescent Girls With Anorexia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 5, 2021 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Badr University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Randomized control study used to identify the effect of aerobic exercises on the activity of daily living and estradiol serum level in young girls with anorexia

Detailed Description

Control group will receive diet program while the study group received the same diet program given to control group in addition to AEROBIC exercise program. Inclusive criteria Thirty girls with anorexia BMI ≤ 18 kg/m2 Age ranged from (14-17 years). Exclusive criteria: Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone. Exclude any other eating disorders Data analysis and statistical design: The collected data will be statistically treated using: Descriptive statistics. Inferential statistics using: Paired t-test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia in Adolescence

Keywords

anorexia, adolescent girls, areobic exercises

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

DIET PROGRAM IN ADDITION TO AEROBIC EXRCISES

Arm Title

Group B

Arm Type

Other

Arm Description

DIET PROGRAM

Intervention Type

Other

Intervention Name(s)

aerobic exercises + Diet

Intervention Description

Frequency 5-6 days per week Intensity To perform moderate intensity for weight-bearing aerobic exercise Time Goal of 20-30 min per session of moderate-intensity aerobic activity per week

Intervention Type

Other

Intervention Name(s)

diet proram

Intervention Description

diet program for anorexic adolescent girls

Primary Outcome Measure Information:

Title

Estradiol level

Description

blood test

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Thirty girls with anorexia BMI ≤ 18 kg/m2 Age ranged from (14-17 years). Exclusion Criteria: Girls did not receive any exogenous steroid and other treatment which could affect plasma levels of estrogen hormone.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mariam EL Ebrashy, Phd

Phone

01001716570

Mariam.elabrashi@buc.edu.eg

Facility Information:

Facility Name

Badr University

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariam El Ebrashy, Phd

Phone

01001716570

Mariam.elabrashi@buc.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Effect of Aerobic Exercises and Nutrition In Adolescent Girls With Anorexia

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