Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome

NCT05507255 | Completed

• 1 other identifier: P.T.REC/012/003807
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premenstrual Syndrome

Keywords

Aerobic exercise; Relaxation training; Diurnal cortisol pattern; Premenstrual syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Relaxation training

ACTIVE COMPARATOR

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

Other: Relaxation training

The same relaxation training plus an aerobic exercise program

EXPERIMENTAL

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; Other: An aerobic exercise program

Interventions

Relaxation training OTHER

Relaxation training in the form of deep breathing exercises

Relaxation training; The same relaxation training plus an aerobic exercise program

An aerobic exercise program 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.

The same relaxation training plus an aerobic exercise program

Eligibility Criteria

• Age: 18 Years - 23 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Doaa Osman

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

EG (1)