Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome

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

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

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Other: Relaxation training; Other: An aerobic exercise program

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of physical therapy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 23 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Doaa Osman, Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Aerobic exercise; Premenstrual syndrome; Relaxation training; Diurnal cortisol pattern
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: P.T.REC/012/003807

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No