Clinical trial NCT05507255: Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome
Official title: Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Aerobic exercise
Relaxation training
Diurnal cortisol pattern
Premenstrual syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Sedentary, virginal, adult, non-smoker females suffering from premenstrual syndrome.
2. They should have regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days)
3. 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.
4. No traumatic life events in the last 2 months before starting the study.
5. Their age will be 18-23 years
6. Their body mass index (BMI) will be less than 30 kg/m2.

Exclusion Criteria:

1. Menstrual problems (e.g. menorrhagia, metrorhagia and polycystic ovary disease).
2. Cardio-respiratory, renal, neurological and pelvic inflammatory diseases, tumors, infections, anemia, diabetes, hypertension, asthma, rheumatoid arthritis, headache, migraine, thyroid or mental disorders.
3. Participation at any other exercise training program during this study.
4. Receiving any kind of medications, hormonal treatment or supplementation (vitamin, mineral or herbal supplement).

Primary outcomes:
measure: Diurnal cortisol pattern
timeFrame: 8 weeks
measure: Severity of premenstrual symptoms
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical therapy, Cairo University
Study officials:
affiliation: Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
name: Doaa Osman
role: PRINCIPAL_INVESTIGATOR
References: