Back to resultsEffect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome
Primary Purpose
Premenstrual Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Relaxation training
An aerobic exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Aerobic exercise, Relaxation training, Diurnal cortisol pattern, Premenstrual syndrome
Eligibility Criteria
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).
Sites / Locations
- Faculty of Physical therapy, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Relaxation training
The same relaxation training plus an aerobic exercise program
Arm Description
Females will receive relaxation training, in the form of deep breathing, 3 days per week, for 8 weeks.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05507255
Brief Title
Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome
Official Title
Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Aerobic exercise, Relaxation training, Diurnal cortisol pattern, Premenstrual syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Random generator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relaxation training
Arm Type
Active Comparator
Arm Description
Females will receive relaxation training, in the form of deep breathing, 3 days per week, for 8 weeks.
Arm Title
The same relaxation training plus an aerobic exercise program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Relaxation training
Intervention Description
Relaxation training in the form of deep breathing exercises
Intervention Type
Other
Intervention Name(s)
An aerobic exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diurnal cortisol pattern
Description
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.
Time Frame
8 weeks
Title
Severity of premenstrual symptoms
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa Osman
Organizational Affiliation
Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical therapy, Cairo University
City
Giza
Country
Egypt
12. IPD Sharing Statement
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Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome
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