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Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS). (PMS)

Primary Purpose

Premenstrual Syndrome, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic circuit training
Outdoor walk
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Aerobic Training

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Sites / Locations

  • Fauji Foundation hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Circuit Training

outdoor walk

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect on Health- Related Quality of Life.
Use to Assess Health-Related Quality of Life. It consists of five questions,and Likert -type, Measurements of scale are set according to as a range from one (none of the time) to five (all of the time).

Full Information

First Posted
August 11, 2021
Last Updated
April 21, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05349344
Brief Title
Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS).
Acronym
PMS
Official Title
Effect of Aerobic Exercise Training on Premenstrual Syndrome Symptoms and Health Related Quality of Life Among Working Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

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.
Detailed Description
A review conducted to assess the effect of 8 weeks of aerobic exercise on the non-athletic females facing premenstrual syndrome symptoms. The results displayed positive effects of 8 weeks of exercise on symptoms of PMS. The aerobic exercise helped to reduce both psychological and physical symptoms. Regular swimming for 8 weeks also decreased the severity of PMS symptoms in females. Results deduced that the exercise improved the vascular activity of the heart, and reduced stress and anxiety. Moreover, it also enhanced bone density. In one of RCT the effect of 3 months of exercise through treadmill on PMS and hormones was also evaluated. It was assumed that many symptoms of PMS were reduced including the carbohydrate cravings, stress, and depression. The electrolyte change was also reduced. Exercise also reduced the proportion of backache and menstrual cramps in females. Another review on a balanced diet and regular exercise demonstrated that the diet rich in the essential nutrients and regular exercise improved the health of the females. The symptoms of PMS were also reduced in these females along with the intensity of dysmenorrhea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Quality of Life
Keywords
Aerobic Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Circuit Training
Arm Type
Experimental
Arm Description
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.
Arm Title
outdoor walk
Arm Type
Active Comparator
Arm Description
30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks).
Intervention Type
Other
Intervention Name(s)
Aerobic circuit training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Outdoor walk
Intervention Description
30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks).
Primary Outcome Measure Information:
Title
Severity of Premenstrual Syndrome Symptoms. Premenstrual Syndrome Scale (PMSS)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Effect on Health- Related Quality of Life.
Description
Use to Assess Health-Related Quality of Life. It consists of five questions,and Likert -type, Measurements of scale are set according to as a range from one (none of the time) to five (all of the time).
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Reproductive aged working women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Ehsan, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fauji Foundation hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29350276
Citation
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.
Results Reference
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PubMed Identifier
25279689
Citation
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.
Results Reference
background
Citation
Yilmaz-Akyuz E, Aydin-Kartal Y. The effect of diet and aerobic exercise on PremenstrualSyndrome: Randomized controlled trial. Revista de Nutrição. 2019;32
Results Reference
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Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS).

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