Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome

NCT ID: NCT05507255

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-06-01

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.

Conditions

Premenstrual Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Relaxation training

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

Group Type: ACTIVE_COMPARATOR

Relaxation training

Intervention Type: OTHER

Relaxation training in the form of deep breathing exercises

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.

Group Type: EXPERIMENTAL

Relaxation training

Intervention Type: OTHER

Relaxation training in the form of deep breathing exercises

An aerobic exercise program

Intervention Type: OTHER

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.

Interventions

Relaxation training

Relaxation training in the form of deep breathing exercises

Intervention Type: 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa A. Osman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doaa Osman

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

Locations

Faculty of Physical therapy, Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003807

Identifier Type: -

Identifier Source: org_study_id