Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05507255

Collaborator

(none)

Enrollment

Arms

2.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Premenstrual Syndrome	Other: Relaxation training Other: An aerobic exercise program	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Random generator

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 20, 2022

Anticipated Primary Completion Date :

Oct 20, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Relaxation training Females will receive relaxation training, in the form of deep breathing, 3 days per week, for 8 weeks.	Other: Relaxation training Relaxation training in the form of deep breathing exercises
Experimental: The same relaxation training plus 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.	Other: Relaxation training Relaxation training in the form of deep breathing exercises Other: 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.

Arm

Intervention/Treatment

Active Comparator: Relaxation training

Females will receive relaxation training, in the form of deep breathing, 3 days per week, for 8 weeks.

Other: Relaxation training

Relaxation training in the form of deep breathing exercises

Experimental: The same relaxation training plus 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.

Other: Relaxation training

Relaxation training in the form of deep breathing exercises

Other: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 23 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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).