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

Primary Purpose

Stress, Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercise
Traditional Treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Treatment Arm

Aerobic exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2021
Last Updated
July 26, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04913558
Brief Title
Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women
Official Title
Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Treatment Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aerobic exercise group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Treatment
Intervention Description
General advice for reducing fatigue and stress Fluid and diet advice Carrying the Baby While Breastfeeding in a sitting position Selecting Clothing
Primary Outcome Measure Information:
Title
Stress assessment
Description
Change from baseline of stress at 6 weeks. Assessment of stress through using perceived stress scale 10 will be performed before and after intervention
Time Frame
Baseline and 6 weeks post-intervention
Title
Fatigue assessment
Description
Change from baseline of stress at 6 weeks. Assessment of fatigue through using fatigue assessment scale will be performed before and after intervention
Time Frame
Baseline and 6 weeks post-intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
lactating mothers working in the medical field who have returned to work after maternity leave and suffering from stress and fatigue.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Zaher
Phone
+201127222726
Email
sara.elsayed.zaher@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Zahrer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Dokki
ZIP/Postal Code
12611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Zaher
Phone
+201127222726
Email
sara.elsayed.zaher@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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