NCT05057000

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

September 13, 2021

Last Update Submit

January 1, 2022

Conditions

Anorexia in Adolescence

Keywords

anorexiaadolescent girlsareobic exercises

Outcome Measures

Primary Outcomes (1)

  • Estradiol level

    blood test

    3 months

Study Arms (2)

Group A

EXPERIMENTAL

DIET PROGRAM IN ADDITION TO AEROBIC EXRCISES

Other: aerobic exercises + Diet

Group B

OTHER

DIET PROGRAM

Other: diet proram

Interventions

aerobic exercises + DietOTHER

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

Group A
diet proramOTHER

diet program for anorexic adolescent girls

Group B

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Anorexia

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Mariam EL Ebrashy, Phd

CONTACT

01001716570Mariam.elabrashi@buc.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lectruer of physical therapy for women'shealth

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 27, 2021

Study Start

October 5, 2021

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations

EG(1)