Premenstrual SyndromeNCT05644613
Comparative Study Between The Effect Of Aerobic Exercises On Land and Aerobic Exercises In Water On PMS Syndrome
A study testing aerobic exercise on land and aerobic exercise in water in people with Premenstrual Syndrome, run by Mariam Hossam El Ebrashy at 1 site in Egypt.
Trial summary
Many girls experience premenstrual syndrome PMS which is re a group of physical, cognitive, affective, and behavioural symptoms that occur cyclically during the luteal phase of the menstrual cycle and resolve at or within a few days of the onset of menstruation. Read more about this study
- Who is it for?
- Ages 14 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- aerobic exercise on land and aerobic exercise in water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 30 Apr 2023
- 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 14 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- All participants virgin females.
- Their age ranged from 14 to 17 years old
- their body mass index (BMI) ≥ 18 ≤ 25 kg/m2.
- They are clinically and medically stable during the study,
- they have regular menstrual cycle of 23 to 35 days and not participated any type of unusual diet during the period of the study.
Who cannot join
- All females in this study are free from: cardiopulmonary or orthopaedic problems, taking any hormonal drugs for three months at least, participating in any form of activity rather than the prescribed one in the study, any abnormality in ovulation or pelvic inflammatory diseases (PID).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Badr University
Cairo
Mariam El Ebrashy, Phd, 01001716570, Mariam.elabrashi@buc.edu.eg
About this study
Official title: Effect Of Aerobic Exercises On Land Versus Aerobic Exercises In Water In The Management Of Premenstrual Syndrome In Adolescent Girls
Many girls experience premenstrual syndrome PMS which is re a group of physical, cognitive, affective, and behavioural symptoms that occur cyclically during the luteal phase of the menstrual cycle and resolve at or within a few days of the onset of menstruation. In young adolescents symptoms might particularly affect school functions, and social interactions in a negative ways in this study we will figure out the effect of 2 kinds of exercises in the management of this syndrome.
Read the detailed description
Fourty adolescent girls were divided randomly into two equal groups, Group (A) will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercise on land in form of walking on the treadmill for 20 min 3 times per week for 3 months. Group (B) will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercises in water in form of walking on the treadmill for 20 min 3 times per week for 3 months the assessment of the PMS symptoms will be done by Premenstrual distress questionnaire
- Conditions
- Premenstrual Syndrome
- Being tested
- aerobic exercise on land, aerobic exercise in water
- Keywords
- premenstrual syndrome
- 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 exercise on landOther
aerobic exercise on land in form of walking on the treadmill
aerobic exercise in waterOther
aerobic exercises in water in form of walking on the treadmill
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Active comparator | will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercise on land in form of walking on the treadmill for 20 min 3 times per week for 3 months. Receives: Other: aerobic exercise on land |
| GROUP B | Active comparator | will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercises in water in form of walking on the treadmill for 20 min 3 times per week for 3 months Receives: Other: aerobic exercise in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual syndrome symptoms
PREMENSTRUAL SYNDROME QUESTIONNAIRE
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start15 Dec 2022
- Primary completion2 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariam Hossam El Ebrashy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mariam Hossam El Ebrashy, Badr University
- Investigators
- Mina Atef, Phd, Study director, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644613
- Sponsor's protocol ID
- 2
- Status last verified
- Jan 2023
- First submitted
- 1 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Aerobic Exercises On Land Versus Aerobic Exercises In Water In The Management Of Premenstrual Syndrome In Adolescent Girls
- ClinicalTrials.gov ID
- NCT05644613
- Acronym / sponsor ID
- 2
- Conditions
- Premenstrual Syndrome
- Keywords
- premenstrual syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mariam Hossam El EbrashyUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 9 Dec 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.
Many girls experience premenstrual syndrome PMS which is re a group of physical, cognitive, affective, and behavioural symptoms that occur cyclically during the luteal phase of the menstrual cycle and resolve at or within a few days of the onset of menstruation. In young adolescents symptoms might particularly affect school functions, and social interactions in a negative ways in this study we will figure out the effect of 2 kinds of exercises in the management of this syndrome.
Detailed description
Fourty adolescent girls were divided randomly into two equal groups, Group (A) will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercise on land in form of walking on the treadmill for 20 min 3 times per week for 3 months. Group (B) will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercises in water in form of walking on the treadmill for 20 min 3 times per week for 3 months the assessment of the PMS symptoms will be done by Premenstrual distress questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Active comparator | Other: aerobic exercise on landwill consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercise on land in form of walking on the treadmill for 20 min 3 times per week for 3 months. |
| GROUP B | Active comparator | Other: aerobic exercise in waterwill consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercises in water in form of walking on the treadmill for 20 min 3 times per week for 3 months |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- All participants virgin females.
- Their age ranged from 14 to 17 years old
- their body mass index (BMI) ≥ 18 ≤ 25 kg/m2.
- They are clinically and medically stable during the study,
- they have regular menstrual cycle of 23 to 35 days and not participated any type of unusual diet during the period of the study.
Key exclusion criteria (1 listed)
- All females in this study are free from: cardiopulmonary or orthopaedic problems, taking any hormonal drugs for three months at least, participating in any form of activity rather than the prescribed one in the study, any abnormality in ovulation or pelvic inflammatory diseases (PID).
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 exercise on landaerobic exercise on land in form of walking on the treadmill | Other | GROUP A |
| aerobic exercise in wateraerobic exercises in water in form of walking on the treadmill | Other | GROUP B |
Primary outcome
Premenstrual syndrome symptoms
Time frame: 3 months
PREMENSTRUAL SYNDROME QUESTIONNAIRE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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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.
Mina Atef, Phd study director
Badr 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 exercise on land and aerobic exercise in water in people with Premenstrual Syndrome, run by Mariam Hossam El Ebrashy at 1 site in Egypt.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARIAM Dr EL EBRASHY, Phd (01001716570 ext. +2, Mariam.elabrashi@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual syndrome symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2023.