Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women

July 26, 2021 updated by: Sara Elsayed Basyouny Zaher, Cairo University
The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women.

Study Overview

Status

Status

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

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

The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women. This study will be carried out on Sixty lactating mothers working in the medical field who have returned to work after maternity leave and suffering from stress and fatigue.

The subjects will be divided randomly into two groups equal in number, the Aerobic exercise group ( group A) and the Control group ( group B).

Group A will consist of thirty employed lactating women suffering from stress and fatigue. These women will perform aerobic exercise for 30 minutes for each session, 5 times per week, for 6 weeks in the form of treadmill training (60- 70% of HR max) and do some modifications of their routine by following lifestyle modification advice given to them during the 6 weeks of the program period.

Control group (group B):

This group will consist of thirty employed lactating women suffering from stress and fatigue. This group will receive the same lifestyle modification advice that will be given to group (A) during the six weeks of the program period.

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.
Interventional

Enrollment (Anticipated)

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.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

25 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All participants are lactating mothers.
  • Working in the medical field 4 to 6 hours per day, 4 to 5 days per week.
  • Returned to work after 4 months of maternity leave.
  • Suffering stress and fatigue considering the perceived stress questionnaire and the fatigue assessment scale.
  • Their babies' ages will be ranged from 6 to 8 months old.
  • Having at least one year of work experience before giving birth.
  • Their age will be ranged from 25 to 35 years.
  • They haven't exercised more than twice per week during the previous 3 months.

Exclusion Criteria:

  • Any neurological, cardiovascular disorders, or metabolic disease
  • Physical impairments that prevent following the program.
  • Women who are planning to stop breastfeeding in the next 4 months.
  • Women with regular medications.
  • Mothers of formula feeding babies.
  • women who are smoking will be excluded from this study.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Traditional Treatment Arm
This group will consist of thirty employed lactating women suffering from stress and fatigue. This group will receive the same lifestyle modification advice that will be given to the aerobic exercise group during the six weeks of the program period.
Other: Traditional Treatment
  1. General advice for reducing fatigue and stress
  2. Fluid and diet advice
  3. Carrying the Baby
  4. While Breastfeeding in a sitting position
  5. Selecting Clothing
Experimental: Aerobic exercise group
This group will consist of thirty employed lactating women suffering from stress and fatigue. These women will perform aerobic exercise for 30 minutes for each session, 5 times per week, for 6 weeks in the form of treadmill training (60- 70% of HR max) and do some modifications of their routine by following lifestyle modification advice given to them during the 6 weeks of the program period.
Other: Traditional Treatment
  1. General advice for reducing fatigue and stress
  2. Fluid and diet advice
  3. Carrying the Baby
  4. While Breastfeeding in a sitting position
  5. Selecting Clothing
Other: Aerobic exercise

The exercise will be performed by using the treadmill as the following:

- The first stage (warming up): It consists of 5 minutes warming up with the treadmill speed set at 1.0 mile per hour.

- The second stage (active stage): It consists of 20 minutes with the treadmill speed set at 3.0 miles per hour.

- Third stage (cooling down): It consists of 5 minutes of cooling down with the treadmill speed set at 1.0 miles per hour.

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
Stress assessment
Time Frame: Baseline and 6 weeks post-intervention
Change from baseline of stress at 6 weeks. Assessment of stress through using perceived stress scale 10 will be performed before and after intervention
Baseline and 6 weeks post-intervention
Fatigue assessment
Time Frame: Baseline and 6 weeks post-intervention
Change from baseline of stress at 6 weeks. Assessment of fatigue through using fatigue assessment scale will be performed before and after intervention
Baseline and 6 weeks post-intervention

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: Sara Zahrer, Cairo University

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.
May 1, 2021

Primary Completion (Anticipated)

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 15, 2021

Study Completion (Anticipated)

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.
November 30, 2021

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).
May 29, 2021

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.
May 29, 2021

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.
June 4, 2021

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.
July 27, 2021

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.
July 26, 2021

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.
July 1, 2021

More Information

Terms related to this study

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.
  • Sarazaher_Msc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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