Premenstrual SyndromePMSNCT05349344
Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS).
A study testing Aerobic circuit training and Outdoor walk in people with Premenstrual Syndrome and Quality of Life, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Quality of Life
- What is being tested?
- Aerobic circuit training and Outdoor walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Sep 2020to 1 Aug 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aerobic Exercise Training on Premenstrual Syndrome Symptoms and Health Related Quality of Life Among Working Women
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.
Read the 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.
- Conditions
- Premenstrual Syndrome, Quality of Life
- Being tested
- Aerobic circuit training, Outdoor walk
- Keywords
- Aerobic Training
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Outdoor walkOther
30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Outdoor walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start20 Sep 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Ehsan, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349344
- Sponsor's protocol ID
- REC/00841 Hareem Javed
- Acronym
- PMS
- Status last verified
- Apr 2022
- First submitted
- 11 Aug 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29350276El-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.
PubMed 25279689Yilmaz-Akyuz E, Aydin-Kartal Y. The effect of diet and aerobic exercise on PremenstrualSyndrome: Randomized controlled trial. Revista de Nutrição. 2019;32
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Training on Premenstrual Syndrome Symptoms and Health Related Quality of Life Among Working Women
- ClinicalTrials.gov ID
- NCT05349344
- Acronym / sponsor ID
- PMS / REC/00841 Hareem Javed
- Conditions
- Premenstrual Syndrome, Quality of Life
- Keywords
- Aerobic Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 27 Apr 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Circuit Training | Experimental | Other: Aerobic circuit trainingEach session consists of 5 minutes of warming up,20 minutes of aerobic exercises with brief resting periods, followed by 5 minutes to cool down. |
| outdoor walk | Active comparator | Other: Outdoor walk30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
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 circuit trainingAerobic 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). | Other | Aerobic Circuit Training |
| Outdoor walk30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks). | Other | outdoor walk |
Primary outcome
Severity of Premenstrual Syndrome Symptoms. Premenstrual Syndrome Scale (PMSS)
Time frame: 8 weeks
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.
1 secondary outcome
Effect on Health- Related Quality of Life.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 29350276Maged 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.
- Background: PubMed 25279689El-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.
- BackgroundYilmaz-Akyuz E, Aydin-Kartal Y. The effect of diet and aerobic exercise on PremenstrualSyndrome: Randomized controlled trial. Revista de Nutrição. 2019;32
- 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.
Sarah Ehsan, PP-DPT principal investigator
Riphah International 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 circuit training and Outdoor walk in people with Premenstrual Syndrome and Quality of Life, run by Riphah International University at 1 site in Pakistan.
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 4 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: finished, as of the sponsor's last update on 27 Apr 2022. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Premenstrual Syndrome Symptoms. Premenstrual Syndrome Scale (PMSS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349344, which also lists 3 linked publications.
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 Apr 2022.