Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome

Premenstrual Syndrome Clinical Trial

Official title:

Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05507255
• Other study ID #: P.T.REC/012/003807
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 23 Years

Eligibility

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).

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Relaxation training
Relaxation training in the form of deep breathing exercises
• An aerobic exercise program
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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical therapy, Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks