Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise

Sponsor

Al-Azhar University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05198115

Collaborator

(none)

Enrollment

Arms

2.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aerobic Exercise Premenstrual Syndrome	Behavioral: aerobic exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Eight Weeks of Aerobic ExerciseEight Weeks of Aerobic Exercise

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise

Anticipated Study Start Date :

Feb 25, 2022

Anticipated Primary Completion Date :

Apr 25, 2022

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Emotional (EM) scale [eight weeks]
emotional scale from [0 to 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Said Ali, dr ahmedsaidali MCs candidate Principal Investigator, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05198115

Other Study ID Numbers:

3574

First Posted:

Jan 20, 2022

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Syndrome

Premenstrual Syndrome

Study Results

No Results Posted as of Feb 22, 2022