Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome

Not Applicable

Completed

• Conditions: Premenstrual Syndrome
• Interventions: Other: Relaxation training; Other: An aerobic exercise program

• Registration Number: NCT05507255
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-18
• Study Start: 2023-02-01
• Status Verified: 2023-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation training	Relaxation training	Females 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	Relaxation training	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.
The same relaxation training plus an aerobic exercise program	An aerobic exercise program	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.

Primary Outcome Measures

Name	Time	Method
Diurnal cortisol pattern	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	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.

Trial Locations

Locations (1)

Faculty of Physical therapy, Cairo University; 🇪🇬 Giza, Egypt