Effect of Aerobic Exercises and Nutrition In Adolescent G... | NCT05057000

Studies
Effect of Aerobic Exercises and Nutrition In Adolescent Girls With Anorexia

NCT05057000

Sponsor

Badr University

Status

Unknown status

Last Update Posted

Jan 4, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Anorexia in Adolescence

Interventions

aerobic exercises + Diet
diet proram

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2021Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Sep 13, 2021

First Submission Date that Met QC Criteria

Sep 20, 2021

First Posted Date

Sep 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2022

Last Update Posted Date

Jan 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mariam Hossam El Ebrashy, Lectruer of physical therapy for women'shealth, Badr UniversityPrincipal Investigator

Lead Sponsor

Badr UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	DIET PROGRAM IN ADDITION TO AEROBIC EXRCISES	Other: aerobic exercises + Diet
Group B	Other	DIET PROGRAM	Other: diet proram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aerobic exercises + Diet	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estradiol level	blood test	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mariam EL Ebrashy, Phd	Contact	01001716570		Mariam.elabrashi@buc.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Badr University	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000855	Anorexia

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D004032	Diet

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided