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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05349344
Other study ID # REC/00841 Hareem Javed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2020
Est. completion date August 1, 2021

Study information

Verified date April 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic circuit training
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).
Outdoor walk
30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks).

Locations

Country Name City State
Pakistan Fauji Foundation hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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). 8 weeks
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