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Effect of Zumba Dance on Premenstrual Tension

Primary Purpose

Premenstrual Tension

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
zumba dance fitness
non zumba dance
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Tension

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Bahgat Gym and Spa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

zumba dance group

non zumba dance group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
May 8, 2018
Last Updated
June 17, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03529721
Brief Title
Effect of Zumba Dance on Premenstrual Tension
Official Title
Effect of Zumba Dance on Premenstrual Tension:8 Weeks Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
April 20, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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 Each class was one hour in length and a recovery period of at least 48 hours will be taken between classes. The Zumba® fitness scheduling of sessions will be self-selected by the participants. The Zumba sessions will be conducted at a fitness center (SAMIA ALLOUBA gym and fitness center) and will consist 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. The Zumba sessions will be supervised by three certified Zumba instructors, each responsible for regular sessions per week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Tension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zumba dance group
Arm Type
Experimental
Arm Description
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.
Arm Title
non zumba dance group
Arm Type
Placebo Comparator
Arm Description
the control group will be required to carry on doing their normal daily activities throughout the 8-week period.
Intervention Type
Other
Intervention Name(s)
zumba dance fitness
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
non zumba dance
Other Intervention Name(s)
control group
Intervention Description
participants in this group will be doing their normal daily activities throughout the 8-week period.
Primary Outcome Measure Information:
Title
Premenstrual distress questionnaire
Description
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)
Time Frame
3 months after start of zumba dance fitness.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED SAMY, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahgat Gym and Spa
City
Cairo
ZIP/Postal Code
11231
Country
Egypt

12. IPD Sharing Statement

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Effect of Zumba Dance on Premenstrual Tension

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