Premenstrual SyndromeNCT07684495
Aerobic Exercises Versus Sub Occipital Myofascial Release on Memory Function in Females With Premenstrual Syndrome.
A study testing Aerobic exercise and Sub occipital myofascial release in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of aerobic exercises versus sub occipital Myofascial release on memory functions in females with premenstrual syndrome. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Aerobic exercise and Sub occipital myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with premenstrual syndrome and memory function deficits have to meet the following criteria in order to participate in this study:
- Their age ranged from 18 to 30 years old.
- Their body mass index (BMI) ranged from 18.5 - 30 kg/cm2.
Who cannot join
- Any medications that can affect central nervous system or memory function.
- Any neurological disorders affect their memory function.
- Pregnant women.
- Daily smokers.
- Had a concussion or head trauma within the past 30 days.
- Took any illegal drugs or alcohol within the past 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to investigate the effect of aerobic exercises versus sub occipital Myofascial release on memory functions in females with premenstrual syndrome.
Read the detailed description
The pooled prevalence of reproductive age women affected with premenstrual syndrome (PMS) worldwide amounts to 47.8%. Among these, about 20% of women experience symptoms severe enough to disrupt their daily activities, and the remaining have mild to moderate symptoms. They can experience an exacerbation of insomnia, memory problems, difficulty maintaining focus, and fatigue in the both follicular phase and luteal phase, but more noticed during the luteal phase. Memory deficit could affect those women social activities and one's daily positive functioning. Therefore, some females and their providers seek alternative treatments such as Aerobic exercise which represents a cost-effective, widely available, natural, and self-administered treatment with no adverse side effects, and it is reported that Aerobic exercise resulted in 16.5% increase in hippocampal volume and 53.7% increase in memory, as well as increased hippocampal resting-state functional connectivity.
And also, it is found the noticed role of suboccipital muscles release in improving memory functions through enhancing cerebral blood flow to the brain via vertebral artery, and also regulation of cortisol level that interferes with memory and stress.
Till now, there is no previous study illustrating the difference between the effect of aerobic exercise and sub occipital muscle release on memory functions in females with PMS. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.
- Conditions
- Premenstrual Syndrome
- Being tested
- Aerobic exercise, Sub occipital myofascial release
- 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 exerciseOther
A moderate-intensity aerobic exercise session on a treadmill consists of three phases: warm-up, active phase, and cool-down. The warm-up lasts 5-10 minutes and involves walking at minimum speed (2.0 - 3.0 km/h) with a slight incline (1 -2%) or as tolerated. The active phase, lasting 20-30 minutes, maintains a brisk walking or light jogging pace with moderate speed (4.5-6.5 km/h) or as tolerated. This phase can include steady-state jogging or intervals of walking and jogging to sustain cardiovascular engagement. Finally, the cool-down phase lasts 5-10 minutes, where the speed is gradually reduced to 2.0 - 3.0 km/h, allowing the heart rate to decrease safely.
Sub occipital myofascial releaseOther
The patient will be asked to take a supine position, and a pillow will be placed under the patient's head for comfort until starting the procedure, the patient will be instructed to be relaxed, then the therapist will sit at the head of the bed and will place both hands underneath the patient's head in the occipital region. The therapist should then feel for the occipital ridge along the scalp and move the hands slightly caudal until the muscle is felt. The therapist then will flex the fingers upward against the suboccipital muscles and this position will be hold for 3 to 5 minutes or until significant muscle tension will be released.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group | Experimental | The participants will receive aerobic exercise program for 30 minutes, 3 sessions per week for 6 weeks. Receives: Other: Aerobic exercise |
| Sub occipital myofascial release group | Experimental | The participants will receive sub occipital myofascial release treatment 3 sessions per week for 6weeks. Receives: Other: Sub occipital myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory function
Assessment of memory function will be done by the free recall test. The word list will contain 10 words selected randomly. These words would be administered to the patient one by one with interval time 1 second between each word with total words presentation time 10 seconds.
The presentation of these words will be though a digital screen using a designed video showing these words arranged in order with a fixed interval 1 second between each word.
The patient will be instructed immediately to recall these words verbally at any order.
The total score is 10 and one point will be accounted for each word will be recalled correctly
Measured: 6 weeks
Prospective and retrospective memory questionnaire (PRMQ)
It will be used to assess memory functions. The measure consists of 16 individual items.
The Structure of the PRMQ consists of 16 Items total , each item is rated on a 5-point scale (1 = Never , 2 = Rarely , 3 = Sometimes , 4 = Often , 5 = Very Often). These 16 items, evenly divided into 8 prospective memory items and 8 retrospective memory items. Each item describes a common memory lapse, giving a high score to an item means a high memory deficits at that item. The total score ranges from 16 to 80, with higher scores indicating a greater frequency of memory lapse and deficit.
Measured: 6 weeks
Secondary outcomes (2)
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a widely used self-report instrument developed to to assess the degree to which individuals perceive situations in their lives as stressful during the previous month. The most commonly used version, the 10-item Perceived Stress Scale (PSS-10), consists of 10 questions rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Participants complete the questionnaire independently, the total score is obtained by summing the responses to all items, resulting in a score ranging from 0 to 40, with higher scores indicating greater perceived stress. Although there are no universally accepted cut-off values, scores of 0-13 are generally considered to indicate low perceived stress, 14-26 moderate perceived stress, and 27-40 high perceived stress.
Measured: 6 weeks
Cervical pain intensity
The Visual Analogue Scale (VAS) will be used to assess pain intensity. It is a simple, valid, and reliable self-report instrument widely used to assess the intensity of subjective symptoms such as pain, stress, fatigue, and mood. It consists of a 10-cm horizontal line with two endpoints representing the extremes of the symptom being measured (e.g., "no pain" at one end and "worst imaginable pain" at the other). Participants are instructed to place a mark on the line at the point that best represents the intensity of their current symptom. The score is determined by measuring the distance in millimeters or centimeters from the left endpoint to the participant's mark, yielding a value ranging from 0 to 100 mm (or 0-10 cm), with higher scores indicating greater symptom intensity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start3 Jul 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Mohamed Ali Ahmed, Cairo University
- Investigators
- Elham Hassan, As Professor, Study director, Cairo UniversityAmel Youssef, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684495
- Sponsor's protocol ID
- P.T.REC/012/006325
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercises Versus Sub Occipital Myofascial Release on Memory Function in Females With Premenstrual Syndrome.
- ClinicalTrials.gov ID
- NCT07684495
- Acronym / sponsor ID
- P.T.REC/012/006325
- Conditions
- Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Jul 2026 (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.
This study will be conducted to investigate the effect of aerobic exercises versus sub occipital Myofascial release on memory functions in females with premenstrual syndrome.
Detailed description
The pooled prevalence of reproductive age women affected with premenstrual syndrome (PMS) worldwide amounts to 47.8%. Among these, about 20% of women experience symptoms severe enough to disrupt their daily activities, and the remaining have mild to moderate symptoms. They can experience an exacerbation of insomnia, memory problems, difficulty maintaining focus, and fatigue in the both follicular phase and luteal phase, but more noticed during the luteal phase. Memory deficit could affect those women social activities and one's daily positive functioning. Therefore, some females and their providers seek alternative treatments such as Aerobic exercise which represents a cost-effective, widely available, natural, and self-administered treatment with no adverse side effects, and it is reported that Aerobic exercise resulted in 16.5% increase in hippocampal volume and 53.7% increase in memory, as well as increased hippocampal resting-state functional connectivity.
And also, it is found the noticed role of suboccipital muscles release in improving memory functions through enhancing cerebral blood flow to the brain via vertebral artery, and also regulation of cortisol level that interferes with memory and stress.
Till now, there is no previous study illustrating the difference between the effect of aerobic exercise and sub occipital muscle release on memory functions in females with PMS. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group | Experimental | Other: Aerobic exerciseThe participants will receive aerobic exercise program for 30 minutes, 3 sessions per week for 6 weeks. |
| Sub occipital myofascial release group | Experimental | Other: Sub occipital myofascial releaseThe participants will receive sub occipital myofascial release treatment 3 sessions per week for 6weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females with premenstrual syndrome and memory function deficits have to meet the following criteria in order to participate in this study:
- Their age ranged from 18 to 30 years old.
- Their body mass index (BMI) ranged from 18.5 - 30 kg/cm2.
Key exclusion criteria (6 listed)
- Any medications that can affect central nervous system or memory function.
- Any neurological disorders affect their memory function.
- Pregnant women.
- Daily smokers.
- Had a concussion or head trauma within the past 30 days.
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 exerciseA moderate-intensity aerobic exercise session on a treadmill consists of three phases: warm-up, active phase, and cool-down. The warm-up lasts 5-10 minutes and involves walking at minimum speed (2.0 - 3.0 km/h) with a slight incline (1 -2%) or as tolerated. The active phase, lasting 20-30 minutes, maintains a brisk walking or light jogging pace with moderate speed (4.5-6.5 km/h) or as tolerated. This phase can include steady-state jogging or intervals of walking and jogging to sustain cardiovascular engagement. Finally, the cool-down phase lasts 5-10 minutes, where the speed is gradually reduced to 2.0 - 3.0 km/h, allowing the heart rate to decrease safely. | Other | Aerobic exercise group |
| Sub occipital myofascial releaseThe patient will be asked to take a supine position, and a pillow will be placed under the patient's head for comfort until starting the procedure, the patient will be instructed to be relaxed, then the therapist will sit at the head of the bed and will place both hands underneath the patient's head in the occipital region. The therapist should then feel for the occipital ridge along the scalp and move the hands slightly caudal until the muscle is felt. The therapist then will flex the fingers upward against the suboccipital muscles and this position will be hold for 3 to 5 minutes or until significant muscle tension will be released. | Other | Sub occipital myofascial release group |
Primary outcome
Memory function
Time frame: 6 weeks
Assessment of memory function will be done by the free recall test. The word list will contain 10 words selected randomly. These words would be administered to the patient one by one with interval time 1 second between each word with total words presentation time 10 seconds. The presentation of these words will be though a digital screen using a designed video showing these words arranged in order with a fixed interval 1 second between each word. The patient will be instructed immediately to recall these words verbally at any order. The total score is 10 and one point will be accounted for each word will be recalled correctly
Prospective and retrospective memory questionnaire (PRMQ)
Time frame: 6 weeks
It will be used to assess memory functions. The measure consists of 16 individual items. The Structure of the PRMQ consists of 16 Items total , each item is rated on a 5-point scale (1 = Never , 2 = Rarely , 3 = Sometimes , 4 = Often , 5 = Very Often). These 16 items, evenly divided into 8 prospective memory items and 8 retrospective memory items. Each item describes a common memory lapse, giving a high score to an item means a high memory deficits at that item. The total score ranges from 16 to 80, with higher scores indicating a greater frequency of memory lapse and deficit.
2 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: 6 weeks
Cervical pain intensity
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Related trials for Premenstrual Syndrome
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
Active, not recruiting
Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls
Premenstrual Syndrome
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.
Elham Hassan, As Professor study director
Cairo University
Amel Youssef, Professor study chair
Cairo 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 and Sub occipital myofascial release in people with Premenstrual Syndrome, run by Cairo University 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 3 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gehad Ali, Bachelor (01140675084, jihad7mohammad7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory function (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 6 Jul 2026.