NCT03264612

Brief Summary

Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards. The exercise included three stages: warming up, swimming and cooling down.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 25, 2017

Last Update Submit

August 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Premenstrual distress questionnaire

    47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise)

    3 months after start of swimming

Study Arms (2)

Swimming group

ACTIVE COMPARATOR

Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards. The exercise included three stages: warming up, swimming and cooling down.

Behavioral: Aerobic exercise

Non swimming group

NO INTERVENTION

no intervention

Interventions

Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards. The exercise included three stages: warming up, swimming and cooling down.

Also known as: Swimming
Swimming group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • virgins.
  • Their age ranged from 18 to 25 years old
  • Their body mass index (BMI) ranged from 18 to 25 kg/m2.
  • They were clinically and medically stable during the study
  • Have regular menstrual cycle of 23 to 35 days duration

You may not qualify if:

  • cardiopulmonary or orthopaedic problems
  • women taking any hormonal drugs or drugs that affect hormones as antidepressnats during the preceding 3 months before participation in the study
  • any abnormality in ovulation or those with pelvic inflammatory diseases (PID).
  • Women with endocrine abnormality as thyroid, pituitary or ovarian disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Related Publications (1)

  • Maged AM, Abbassy AH, Sakr HRS, Elsawah H, Wagih H, Ogila AI, Kotb A. Effect of swimming exercise on premenstrual syndrome. Arch Gynecol Obstet. 2018 Apr;297(4):951-959. doi: 10.1007/s00404-018-4664-1. Epub 2018 Jan 19.

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

ExerciseSwimming

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLocomotion

Study Officials

  • Ahmed Maged, MD

    kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 29, 2017

Study Start

April 3, 2016

Primary Completion

May 14, 2017

Study Completion

August 12, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations