NCT03529721

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 will be filled at the start and at end of the study (before and after performing swimming exercise) Females in group I will be instructed to engage into 12 classes of 60-minute Zumba® fitness over an 8-week period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

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

First Submitted

Initial submission to the registry

May 8, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

10 months

First QC Date

May 8, 2018

Last Update Submit

June 17, 2019

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 will be filled at the start and at end of the study (before and after performing zumba dance fitness)

    3 months after start of zumba dance fitness.

Study Arms (2)

zumba dance group

EXPERIMENTAL

females in this group will be instructed to engage into12 classes of 60-minute Zumba® fitness over an 8-week period of continuous dance movements to Latin music with varying intensity level throughout the sessions. 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.

Other: zumba dance fitness

non zumba dance group

PLACEBO COMPARATOR

the control group will be required to carry on doing their normal daily activities throughout the 8-week period.

Other: non zumba dance

Interventions

females in this group will be instructed to engage into12 classes of 60-minute Zumba® fitness over an 8-week period of continuous dance movements to Latin music with varying intensity level throughout the sessions. 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.

zumba dance group

participants in this group will be doing their normal daily activities throughout the 8-week period.

Also known as: control group
non zumba dance group

Eligibility Criteria

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

You may qualify if:

  • Age:18-25 years.
  • BMI :18-25 kg/m2.
  • A regular menstrual cycle of 23-35 days duration.
  • No previous practice of Zumba.
  • Free from musculoskeletal injury.
  • All women did not use oral contraceptive pills or any psychotropic agents.

You may not qualify if:

  • Pregnancy.
  • Metabolic/cardiorespiratory contraindications to physical exercise.
  • Cigarette smokers.
  • Recovering from a major injury or illness; or using anti-inflammatory, hyperlipidemia or hypertension medication.
  • any abnormality in ovulation or those with pelvic inflammatory diseases (PID) or a history of endometriosis.
  • Women with endocrine abnormality as diabetes mellitus, thyroid, pituitary, or ovarian disorders.
  • Women who are taking any hormonal drugs or drugs that affect hormones as antidepressant drugs during the preceding three months before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahgat Gym and Spa

Cairo, 11231, Egypt

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • AHMED SAMY, MD

    Cairo University

    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
lecturer in obstetrics and gynecology

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 18, 2018

Study Start

June 20, 2018

Primary Completion

April 20, 2019

Study Completion

May 1, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations