Hematological Factors and Iron Status in Aerobic Versus Anaerobic Training in Athletic Females

September 24, 2023 updated by: Doaa A. Osman, Cairo University

Hematological Factors and Iron Status in Aerobic Versus Anaerobic Training in Athletic Females: An Observational Study

This study aimed to evaluate the hematological factors and iron status in aerobic versus anaerobic training in athletic females.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In both the short and long term, physical training causes iron status deterioration in sporty females. Nonetheless, little is known about the effect of different forms of exercise (aerobic versus anaerobic) on haematological variables and iron status in sporty females during adolescence. As a result, the purpose of this study was to compare the haematological variables and iron status in aerobic versus anaerobic exercise in adolescent female athletes. Another goal was to compare aerobic and anaerobic groups in terms of iron status classifications, such as normal iron status, iron deficiency with or without anaemia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Local clubs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

They were chosen via advertisement in local Cairo clubs.

Description

Inclusion Criteria:

  • Healthy, virginal, nonsmoker, female athletes.
  • Age from 16 to 19 years.
  • Body mass index < 25 kg/m2.
  • Having the same socio-economic level.
  • Following a normal balanced nutrition.

Exclusion Criteria:

  • Using any medical or hormonal therapy that might influence the iron status.
  • Vegetarian athletes.
  • Having menorrhagia or amenorrhea.
  • Chronic inflammatory condition or existing infection.
  • Diabetic, hypertensive or cardiac athletes.
  • Haematological disease (with the exception of iron deficiency with or without anaemia).
  • Having transfusion of blood.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Aerobic group
long distance runners
Other: evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.
evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.
Anaerobic group
broad jumpers
Other: evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.
evaluating blood levels of hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin concentration, serum transferrin and serum ferritin.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of hemoglobin (Hb)
Time Frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure hemoglobin (Hb).
2 months
Assessment of hematocrit (Hct)
Time Frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure hematocrit (Hct).
2 months
Assessment of red blood cell (RBC) count
Time Frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure red blood cell (RBC) count.
2 months
Assessment of mean corpuscular volume (MCV)
Time Frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure mean corpuscular volume (MCV).
2 months
Assessment of mean corpuscular hemoglobin concentration (MCHC)
Time Frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. An automatic cell counter (Sysmex XS 1000, Japan) was used to measure mean corpuscular hemoglobin concentration (MCHC).
2 months
Assessment of serum transferrin
Time Frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. The serum sample was centrifuged, and the serum transferrin was measured using COBAS Integra 400 plus, Switzerland.
2 months
Assessment of serum ferritin
Time Frame: 2 months
Blood samples were collected between 8:00 and 9:00 a.m. after an overnight fast and time of relaxation. The athletic girls were asked to refrain from exercising the day before sample. Blood was taken from the antecubital vein and placed in one EDTA tube and one beads tube for serum separation. The serum sample was centrifuged, and the serum ferritin was measured using ADVIA Centaur XPT, Germany.
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anthropometric measures
Time Frame: 2 months
A weight-height scale was used to assess the weight (Kg) and height (m) for each female athlete in the two groups. The body mass index (BMI) was then calculated by dividing the weight by the height squared (Kg/m2).
2 months
Assessment of participation age to sport
Time Frame: 2 months
Each female athlete was asked about her age of participation to sport to assess her training profile.
2 months
Assessment of number of hours of training per week
Time Frame: 2 months
Each female athlete was asked about the number of hours of training per week to assess her training profile.
2 months
Assessment of training experience
Time Frame: 2 months
The training experience in years was calculated by subtracting the female athlete's age of participation to training from her chronological age.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Doaa A Osman, Assis. Prof., Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004727

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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