NCT04913558

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

May 29, 2021

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Baseline and 6 weeks post-intervention

Study Arms (2)

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.

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.

Other: Aerobic exerciseOther: Traditional Treatment

Interventions

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.

Aerobic exercise group

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

Aerobic exercise groupTraditional Treatment Arm

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailslactating mothers working in the medical field who have returned to work after maternity leave and suffering from stress and fatigue.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Dokki, 12611, Egypt

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sara Zahrer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2021

First Posted

June 4, 2021

Study Start

May 1, 2021

Primary Completion

October 15, 2021

Study Completion

November 30, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations