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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • 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 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

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
Intervention / Treatment
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

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

Cairo University

Investigators

  • 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)

May 1, 2021

Primary Completion (Anticipated)

October 15, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

May 29, 2021

First Submitted That Met QC Criteria

May 29, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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