Premenstrual SyndromeNCT05507255
Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome
A study testing Relaxation training and An aerobic exercise program in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome. Read more about this study
- Who is it for?
- Ages 18 to 23 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Relaxation training and An aerobic exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Jun 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 18 to 23 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Sedentary, virginal, adult, non-smoker females suffering from premenstrual syndrome.
- They should have regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days)
- They should have the following criteria in daily record of severity of problems in at least one of two consecutive menstrual cycles prior to treatment starting to confirm premenstrual syndrome diagnosis: a) more than three items have an average score over 3 during the luteal phase, and b) a luteal phase score is 30% more than a follicular phase score.
- No traumatic life events in the last 2 months before starting the study.
- Their age will be 18-23 years
- Their body mass index (BMI) will be less than 30 kg/m2.
Who cannot join
- Menstrual problems (e.g. menorrhagia, metrorhagia and polycystic ovary disease).
- Cardio-respiratory, renal, neurological and pelvic inflammatory diseases, tumors, infections, anemia, diabetes, hypertension, asthma, rheumatoid arthritis, headache, migraine, thyroid or mental disorders.
- Participation at any other exercise training program during this study.
- Receiving any kind of medications, hormonal treatment or supplementation (vitamin, mineral or herbal supplement).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome: A Randomized Controlled Trial
The aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome.
Read the detailed description
Premenstrual syndrome is manifested by recurrent emotional and depressive symptoms that may be associated with maladaptive coping with stress situations and the enhanced release of stress hormones, like cortisol hormone. Although previous studies revealed a flattened diurnal cortisol slope in women with PMS compared to healthy controls, there is no previous work on the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome. Therefore, this study will aim to investigate the effect of aerobic exercise participation on diurnal cortisol pattern in premenstrual syndrome.This trial will include two groups; group (A) will consist of 14 females who will receive relaxation training for 8 weeks, while group (B) will consist of 14 females who will receive the same relaxation training along with aerobic exercise for 8 weeks.
- Conditions
- Premenstrual Syndrome
- Being tested
- Relaxation training, An aerobic exercise program
- Keywords
- Aerobic exercise, Relaxation training, Diurnal cortisol pattern, 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.
Relaxation trainingOther
Relaxation training in the form of deep breathing exercises
An aerobic exercise programOther
An aerobic exercise program of a moderate intensity, based on the target heart rate (THR) that will be calculated in accordance with Karvonen's equation, using resting heart rate (HRrest), maximal heart rate (HRmax) and training fraction. THR = HRrest (bpm) + (HRmax (bpm) - HRrest (bpm)) × training fraction.The exercise session will have three phases, warming up, active phase and cooling down.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation training | Active comparator | Females will receive relaxation training, in the form of deep breathing, 3 days per week, for 8 weeks. Receives: Other: Relaxation training |
| The same relaxation training plus an aerobic exercise program | Experimental | Females will receive the same relaxation training, in addition to 30 minutes of a moderate aerobic exercise program on a treadmill, 3 days per week, for 8 weeks. Receives: Other: Relaxation training; Other: An aerobic exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal cortisol pattern
It will be evaluated through calculating the ratio of morning cortisol level to evening cortisol level for all participants at baseline and after 8 weeks of treatment.
Measured: 8 weeks
Severity of premenstrual symptoms
Severity of premenstrual symptoms of all participants will be measured through daily record of severity of problems (DRSP) at baseline and after 8 weeks of treatment.
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 posted18 Aug 2022
- Study start1 Feb 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa A. Osman, Cairo University
- Investigators
- Doaa Osman, Principal investigator, Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507255
- Sponsor's protocol ID
- P.T.REC/012/003807
- Status last verified
- Jun 2023
- First submitted
- 16 Aug 2022
- Last updated
- 27 Jun 2023
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05507255
- Acronym / sponsor ID
- P.T.REC/012/003807
- Conditions
- Premenstrual Syndrome
- Keywords
- Aerobic exercise, Relaxation training, Diurnal cortisol pattern, Premenstrual syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 18 Aug 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 aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome.
Detailed description
Premenstrual syndrome is manifested by recurrent emotional and depressive symptoms that may be associated with maladaptive coping with stress situations and the enhanced release of stress hormones, like cortisol hormone. Although previous studies revealed a flattened diurnal cortisol slope in women with PMS compared to healthy controls, there is no previous work on the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome. Therefore, this study will aim to investigate the effect of aerobic exercise participation on diurnal cortisol pattern in premenstrual syndrome.This trial will include two groups; group (A) will consist of 14 females who will receive relaxation training for 8 weeks, while group (B) will consist of 14 females who will receive the same relaxation training along with aerobic exercise for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation training | Active comparator | Other: Relaxation trainingFemales will receive relaxation training, in the form of deep breathing, 3 days per week, for 8 weeks. |
| The same relaxation training plus an aerobic exercise program | Experimental | Other: Relaxation training, Other: An aerobic exercise programFemales will receive the same relaxation training, in addition to 30 minutes of a moderate aerobic exercise program on a treadmill, 3 days per week, for 8 weeks. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sedentary, virginal, adult, non-smoker females suffering from premenstrual syndrome.
- They should have regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days)
- They should have the following criteria in daily record of severity of problems in at least one of two consecutive menstrual cycles prior to treatment starting to confirm premenstrual syndrome diagnosis: a) more than three items have an average score over 3 during the luteal phase, and b) a luteal phase score is 30% more than a follicular phase score.
- No traumatic life events in the last 2 months before starting the study.
- Their age will be 18-23 years
Key exclusion criteria (4 listed)
- Menstrual problems (e.g. menorrhagia, metrorhagia and polycystic ovary disease).
- Cardio-respiratory, renal, neurological and pelvic inflammatory diseases, tumors, infections, anemia, diabetes, hypertension, asthma, rheumatoid arthritis, headache, migraine, thyroid or mental disorders.
- Participation at any other exercise training program during this study.
- Receiving any kind of medications, hormonal treatment or supplementation (vitamin, mineral or herbal supplement).
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 |
|---|---|---|
| Relaxation trainingRelaxation training in the form of deep breathing exercises | Other | Relaxation training, The same relaxation training plus an aerobic exercise program |
| An aerobic exercise programAn aerobic exercise program of a moderate intensity, based on the target heart rate (THR) that will be calculated in accordance with Karvonen's equation, using resting heart rate (HRrest), maximal heart rate (HRmax) and training fraction. THR = HRrest (bpm) + (HRmax (bpm) - HRrest (bpm)) × training fraction.The exercise session will have three phases, warming up, active phase and cooling down. | Other | The same relaxation training plus an aerobic exercise program |
Primary outcome
Diurnal cortisol pattern
Time frame: 8 weeks
It will be evaluated through calculating the ratio of morning cortisol level to evening cortisol level for all participants at baseline and after 8 weeks of treatment.
Severity of premenstrual symptoms
Time frame: 8 weeks
Severity of premenstrual symptoms of all participants will be measured through daily record of severity of problems (DRSP) at baseline and after 8 weeks of treatment.
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 Jun 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.
Doaa Osman principal investigator
Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation training and An aerobic exercise program 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 6 inclusion and 4 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 Jun 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?
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?
Diurnal cortisol pattern (time frame: 8 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 27 Jun 2023.