NCT03561493

Brief Summary

the objective of this study is to investigate the effect of practising Zumba exercise in decreasing menstrual pain in young women with primary dysmenorrhea.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

May 11, 2018

Last Update Submit

June 7, 2018

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

  • Intensity of pain

    Pain intensity will be measured by using a 10-point visual analog scale(VAS) in which a line was calibrated from 0 to 10 with 0 representing ''no pain at all''and 10 representing ''worst pain possible.'' Participants will indicate their perceived pain levels by pointing to the appropriate value on a 10-cm horizontal ruler. The intensity of pain will be rated to the first decimal place in centimeters.Higher scores represent higher menstrual pain intensity.

    duration of menses(5-7 days) 1st menstrual cycle.

  • Intensity of pain

    Pain intensity will be measured by using a 10-point visual analog scale(VAS) in which a line was calibrated from 0 to 10 with 0 representing ''no pain at all''and 10 representing ''worst pain possible.'' Participants will indicate their perceived pain levels by pointing to the appropriate value on a 10-cm horizontal ruler. The intensity of pain will be rated to the first decimal place in centimeters.Higher scores represent higher menstrual pain intensity.

    duration of menses(5-7 days) 2nd menstrual cycle.

Secondary Outcomes (1)

  • menstrual pain duration

    7 days from 1st day of menstruation).

Study Arms (2)

zumba exercise group

EXPERIMENTAL

Participants will engage in 16 classes of 60-minute Zumba® fitness for two consecutive menstrual cycles (an 8-week period, twice weekly). Each class was one h in length and a recovery period of at least 48 h was taken between classes.

Other: zumba exercise

non zumba exercise group

NO INTERVENTION

The participants in the control group did not receive any intervention.

Interventions

zumba exerciseOTHER

Participants will engage in 16 classes of 60-minute Zumba® fitness for two consecutive menstrual cycles (an 8-week period, twice weekly). Each class was one hour in length and a recovery period of at least 48 h was taken between classes. Each session will be initiated with low-intensity movements for the first 5 min, followed by an increasing intensity throughout the workout. At the end of the training session, the intensity will be gradually reduced. The Zumba sessions will be supervised by three certified Zumba instructors, each responsible for regular sessions per week.

Also known as: zumba fittness
zumba exercise group

Eligibility Criteria

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

You may qualify if:

  • having regular menstrual cycles (30-35 days) and bleeding time of 3-10 days.
  • history of primary dysmenorrhea(PD) which had affected daily activities in at least 50% of their cycles through the past 6 months; and pain intensity over 4 cm, based on the 10-cm visual analog scale score.
  • having a pain score for PD on the visual analog scale (VAS) of 4-7 cm
  • Age: 18-25 years.

You may not qualify if:

  • Pregnancy
  • known diseases of the genitourinary system (e.g., pelvic inflammatory disease and urinary tract infections) or secondary dysmenorrhea and chronic diseases (heart disease, respiratory, kidney, blood pressure, asthma, diabetes, epilepsy, migraine, thyroid, anemia, nervous disorders).
  • Previous Zumba fitness practice.
  • irregular menstrual cycles; the use of intra-uterine devices and oral contraceptive pills.
  • musculoskeletal injuries and metabolic/cardiorespiratory contraindications to physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • AHMED SAMY, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED SAMY, MD

CONTACT

00201100681167ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer in obstetrics and gynecology

Study Record Dates

First Submitted

May 11, 2018

First Posted

June 19, 2018

Study Start

June 25, 2018

Primary Completion

September 25, 2018

Study Completion

September 30, 2018

Last Updated

June 19, 2018

Record last verified: 2018-06