NCT05349344

Brief Summary

To Determine the Effect of Regular Aerobic Exercise Training on Severity of Premenstrual Syndrome Symptoms and Health-Related Quality of life on working women.Exercise can be used as an alternative therapy in reducing premenstrual symptoms.But still there is lack of Literature on PMS in work Place and effect of Treatments to improve overall Quality of life in working women.And this study aims to fill the gap by assessing the impact that Premenstrual Syndrome can have on working women's Quality of life and can be used to establish a model of regular exercise program with the potential to decrease premenstrual symptoms and improve quality of life for a menstrual health-friendly workplace environment for Female Employees.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

August 11, 2021

Last Update Submit

April 21, 2022

Conditions

Premenstrual SyndromeQuality of Life

Keywords

Aerobic Training

Outcome Measures

Primary Outcomes (1)

  • Severity of Premenstrual Syndrome Symptoms. Premenstrual Syndrome Scale (PMSS)

    Use to Assess severity of Premenstrual Syndrome Symptoms. This Instrument has 40 questions with three sub-scales(Physiological,Psychological and Behavioral symptoms). It has 5-point Likert-style scale.

    8 weeks

Secondary Outcomes (1)

  • Effect on Health- Related Quality of Life.

    8 weeks

Study Arms (2)

Aerobic Circuit Training

EXPERIMENTAL

Each session consists of 5 minutes of warming up,20 minutes of aerobic exercises with brief resting periods, followed by 5 minutes to cool down.

Other: Aerobic circuit training

outdoor walk

ACTIVE COMPARATOR

30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks).

Other: Outdoor walk

Interventions

Aerobic circuit trainingOTHER

Aerobic Exercise Training, 3 times a week for 8 weeks, (Tuesday, Thursday \& Saturday, 24 sessions Total) 30 min each time, at 60-80 % of HR max (moderate intensity).

Aerobic Circuit Training
Outdoor walkOTHER

30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks).

outdoor walk

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsReproductive aged working women.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Regular menstrual cycles (cycles of 21-35days with a bleeding time of 3-10days).
  • PMS (as per screening questionnaire PSST Criteria).
  • No history of psychiatric disorder (Score below 40 from Beck Depression questionnaire).
  • Women working in hospital settings (health care Professionals).

You may not qualify if:

  • No history of co-existing Medical illness including DM, Thyroid dysfunction, Hypoglycemia, Cardiac Pathologies.
  • Women undergone Hysterectomy or other Gynecological procedure.
  • Women on medications i.e. Contraceptive pills and HRT.
  • Pregnant women.
  • History of drug abuse or Alcohol intake.
  • Participation in another sports program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (3)

  • Maged AM, Abbassy AH, Sakr HRS, Elsawah H, Wagih H, Ogila AI, Kotb A. Effect of swimming exercise on premenstrual syndrome. Arch Gynecol Obstet. 2018 Apr;297(4):951-959. doi: 10.1007/s00404-018-4664-1. Epub 2018 Jan 19.

    PMID: 29350276BACKGROUND

  • El-Lithy A, El-Mazny A, Sabbour A, El-Deeb A. Effect of aerobic exercise on premenstrual symptoms, haematological and hormonal parameters in young women. J Obstet Gynaecol. 2015 May;35(4):389-92. doi: 10.3109/01443615.2014.960823. Epub 2014 Oct 3.

    PMID: 25279689BACKGROUND

  • Yilmaz-Akyuz E, Aydin-Kartal Y. The effect of diet and aerobic exercise on PremenstrualSyndrome: Randomized controlled trial. Revista de Nutrição. 2019;32

    BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah Ehsan, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

April 27, 2022

Study Start

September 20, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)