Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aerobic Exercise; Premenstrual Syndrome
• Intervention / Treatment: Behavioral: aerobic exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic group; 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	Behavioral: aerobic exercise; aerobic training for 8 weeks, 3 times a week, and 60 min each time
Placebo Comparator: Eight Weeks of Aerobic Exercise; 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.	Behavioral: aerobic exercise; aerobic training for 8 weeks, 3 times a week, and 60 min each time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional (EM) scale	emotional scale from [0 to 10]	eight weeks

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 25, 2022
• Primary Completion (Anticipated): April 25, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: December 19, 2021
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: 3574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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