Aerobic ExerciseNCT05198115
Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise
A study testing aerobic exercise in people with Aerobic Exercise and Premenstrual Syndrome, run by Al-Azhar University.
Trial summary
The premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. The aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise, Premenstrual Syndrome
- What is being tested?
- aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2022to 30 Apr 2022
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- young women aged 18-25 years with a body mass index (BMI): 18-25 kg/m2, having regular menstrual cycles of 23-35 days duration, no previous practice of aerobic exercise, free from musculoskeletal injury, not using oral contraceptive pills or taking any psychotropic agents, having no depression or genital tract diseases
Who cannot join
- pregnancy, contraindications to physical exercise, metabolic or cardiorespiratory illness, cigarette smokers, women who recover from a major injury or using anti-inflammatory, hyperlipidemia or hypertension medications, any abnormality in ovulation, and women with diabetes mellitus, thyroid, pituitary, or ovarian disorders
About this study
The premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. The aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome.
Read the detailed description
Premenstrual syndrome is characterized by the presence of both physical and behavioral (including affective) symptoms that occur repetitively in the second half of the menstrual cycle and interfere with some aspects of the woman's life(1). The core symptoms of PMS include affective symptoms, such as irritability, depression, anxiety, and somatic symptoms, such as breast pain, bloating, swelling, and headache (2). Women with moderate to severe PMS symptoms had a reduction in health-related quality of life(3) and work productivity, increased work absenteeism, and visits to ambulatory healthcare providers (4), so the treatment of this syndrome is essential.
- Conditions
- Aerobic Exercise, Premenstrual Syndrome
- Being tested
- aerobic exercise
- 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 exerciseBehavioural
aerobic training for 8 weeks, 3 times a week, and 60 min each time
| Study group | Role | What they receive |
|---|---|---|
| Aerobic group | Active comparator | The intervention consisted of aerobic exercise training, which was taught to participants face-to-face at a meeting. At the end of the session, we provided the intervention group with CDs and educational posters containing all the exercises Receives: Behavioral: aerobic exercise |
| Eight Weeks of Aerobic Exercise | Placebo comparator | The control group was subjected to all the pre-and post-assessments but were not asked to perform the exercise intervention. Instead, we phone-called them to give a reminder for filling out the questionnaires. Receives: Behavioral: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional (EM) scale
emotional scale from [0 to 10]
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start25 Feb 2022 (estimated)
- Primary completion25 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eight Weeks of Aerobic Exercise
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Said Ali, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198115
- Sponsor's protocol ID
- 3574
- Status last verified
- Feb 2022
- First submitted
- 19 Dec 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise
- ClinicalTrials.gov ID
- NCT05198115
- Acronym / sponsor ID
- 3574
- Conditions
- Aerobic Exercise, Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 25 Feb 2022 (estimated)
- Primary completion
- 25 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 20 Jan 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.
The premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. The aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome.
Detailed description
Premenstrual syndrome is characterized by the presence of both physical and behavioral (including affective) symptoms that occur repetitively in the second half of the menstrual cycle and interfere with some aspects of the woman's life(1). The core symptoms of PMS include affective symptoms, such as irritability, depression, anxiety, and somatic symptoms, such as breast pain, bloating, swelling, and headache (2). Women with moderate to severe PMS symptoms had a reduction in health-related quality of life(3) and work productivity, increased work absenteeism, and visits to ambulatory healthcare providers (4), so the treatment of this syndrome is essential.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eight Weeks of Aerobic Exercise
| Arm | Type | Receives |
|---|---|---|
| Aerobic group | Active comparator | Behavioral: aerobic exerciseThe intervention consisted of aerobic exercise training, which was taught to participants face-to-face at a meeting. At the end of the session, we provided the intervention group with CDs and educational posters containing all the exercises |
| Eight Weeks of Aerobic Exercise | Placebo comparator | Behavioral: aerobic exerciseThe control group was subjected to all the pre-and post-assessments but were not asked to perform the exercise intervention. Instead, we phone-called them to give a reminder for filling out the questionnaires. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- young women aged 18-25 years with a body mass index (BMI): 18-25 kg/m2, having regular menstrual cycles of 23-35 days duration, no previous practice of aerobic exercise, free from musculoskeletal injury, not using oral contraceptive pills or taking any psychotropic agents, having no depression or genital tract diseases
Key exclusion criteria (1 listed)
- pregnancy, contraindications to physical exercise, metabolic or cardiorespiratory illness, cigarette smokers, women who recover from a major injury or using anti-inflammatory, hyperlipidemia or hypertension medications, any abnormality in ovulation, and women with diabetes mellitus, thyroid, pituitary, or ovarian disorders
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 exerciseaerobic training for 8 weeks, 3 times a week, and 60 min each time | Behavioural | Aerobic group, Eight Weeks of Aerobic Exercise |
Primary outcome
Emotional (EM) scale
Time frame: eight weeks
emotional scale from [0 to 10]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise in people with Aerobic Exercise and Premenstrual Syndrome, run by Al-Azhar University.
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 1 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 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Emotional (EM) scale (time frame: eight weeks). 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 22 Feb 2022.