Back to resultsPremenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise
Primary Purpose
Aerobic Exercise, Premenstrual Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aerobic exercise
Sponsored by
About this trial
This is an interventional other trial for Aerobic Exercise
Eligibility Criteria
Inclusion Criteria:
- young women aged 18-25 years with a body mass index (BMI): 18-25 kg/m2, having regular menstrual cycles of 23-35 days duration, no previous practice of aerobic exercise, free from musculoskeletal injury, not using oral contraceptive pills or taking any psychotropic agents, having no depression or genital tract diseases
Exclusion Criteria:
- pregnancy, contraindications to physical exercise, metabolic or cardiorespiratory illness, cigarette smokers, women who recover from a major injury or using anti-inflammatory, hyperlipidemia or hypertension medications, any abnormality in ovulation, and women with diabetes mellitus, thyroid, pituitary, or ovarian disorders
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aerobic group
Eight Weeks of Aerobic Exercise
Arm Description
The intervention consisted of aerobic exercise training, which was taught to participants face-to-face at a meeting. At the end of the session, we provided the intervention group with CDs and educational posters containing all the exercises
The control group was subjected to all the pre-and post-assessments but were not asked to perform the exercise intervention. Instead, we phone-called them to give a reminder for filling out the questionnaires.
Outcomes
Primary Outcome Measures
Emotional (EM) scale
emotional scale from [0 to 10]
Secondary Outcome Measures
Full Information
NCT ID
NCT05198115
First Posted
December 19, 2021
Last Updated
February 20, 2022
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05198115
Brief Title
Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise
Official Title
Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 25, 2022 (Anticipated)
Primary Completion Date
April 25, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. The aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome.
Detailed Description
Premenstrual syndrome is characterized by the presence of both physical and behavioral (including affective) symptoms that occur repetitively in the second half of the menstrual cycle and interfere with some aspects of the woman's life(1). The core symptoms of PMS include affective symptoms, such as irritability, depression, anxiety, and somatic symptoms, such as breast pain, bloating, swelling, and headache (2). Women with moderate to severe PMS symptoms had a reduction in health-related quality of life(3) and work productivity, increased work absenteeism, and visits to ambulatory healthcare providers (4), so the treatment of this syndrome is essential.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aerobic Exercise, Premenstrual Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eight Weeks of Aerobic Exercise
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic group
Arm Type
Active Comparator
Arm Description
The intervention consisted of aerobic exercise training, which was taught to participants face-to-face at a meeting. At the end of the session, we provided the intervention group with CDs and educational posters containing all the exercises
Arm Title
Eight Weeks of Aerobic Exercise
Arm Type
Placebo Comparator
Arm Description
The control group was subjected to all the pre-and post-assessments but were not asked to perform the exercise intervention. Instead, we phone-called them to give a reminder for filling out the questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
aerobic training for 8 weeks, 3 times a week, and 60 min each time
Primary Outcome Measure Information:
Title
Emotional (EM) scale
Description
emotional scale from [0 to 10]
Time Frame
eight weeks
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
pms only for women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
young women aged 18-25 years with a body mass index (BMI): 18-25 kg/m2, having regular menstrual cycles of 23-35 days duration, no previous practice of aerobic exercise, free from musculoskeletal injury, not using oral contraceptive pills or taking any psychotropic agents, having no depression or genital tract diseases
Exclusion Criteria:
pregnancy, contraindications to physical exercise, metabolic or cardiorespiratory illness, cigarette smokers, women who recover from a major injury or using anti-inflammatory, hyperlipidemia or hypertension medications, any abnormality in ovulation, and women with diabetes mellitus, thyroid, pituitary, or ovarian disorders
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise
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