StressNCT04913558
Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women
A study testing Aerobic exercise and Traditional Treatment in people with Stress and Fatigue, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- Aerobic exercise and Traditional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Dokki, 12611
Sara Zaher, +201127222726, sara.elsayed.zaher@gmail.com
About this study
The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women.
Read the 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.
- Being tested
- Aerobic exercise, Traditional Treatment
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
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.
Traditional TreatmentOther
- General advice for reducing fatigue and stress
- Fluid and diet advice
- Carrying the Baby
- While Breastfeeding in a sitting position
- Selecting Clothing
| Study group | Role | What they receive |
|---|---|---|
| Traditional Treatment Arm | Active comparator | 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. Receives: Other: Traditional Treatment |
| Aerobic exercise group | Experimental | 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. Receives: Other: Aerobic exercise; Other: Traditional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 weeks post-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
Measured: Baseline and 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 May 2021
- Primary completion15 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Elsayed Basyouny Zaher, Cairo University
- Investigators
- Sara Zahrer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913558
- Sponsor's protocol ID
- Sarazaher_Msc
- Status last verified
- Jul 2021
- First submitted
- 29 May 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women
- ClinicalTrials.gov ID
- NCT04913558
- Acronym / sponsor ID
- Sarazaher_Msc
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Treatment Arm | Active comparator | Other: Traditional TreatmentThis 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. |
| Aerobic exercise group | Experimental | Other: Aerobic exercise, Other: Traditional TreatmentThis 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseThe 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. | Other | Aerobic exercise group |
| Traditional Treatment1. 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 group, Traditional Treatment Arm |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Zahrer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Traditional Treatment in people with Stress and Fatigue, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Zaher (+201127222726, sara.elsayed.zaher@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress assessment (time frame: Baseline and 6 weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.