Premenstrual TensionNCT03529721
Effect of Zumba Dance on Premenstrual Tension
A study testing zumba dance fitness and non zumba dance in people with Premenstrual Tension, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Premenstrual Tension
- What is being tested?
- zumba dance fitness and non zumba dance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Zumba Dance on Premenstrual Tension:8 Weeks Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Premenstrual Tension
- Being tested
- zumba dance fitness, non zumba dance
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zumba dance fitnessOther
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.
non zumba danceOther
Also called control group
participants in this group will be doing their normal daily activities throughout the 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: non zumba dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months after start of zumba dance fitness.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start20 Jun 2018
- Primary completion20 Apr 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual TensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529721
- Sponsor's protocol ID
- zumba dance
- Status last verified
- Jun 2019
- First submitted
- 8 May 2018
- Last updated
- 19 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zumba Dance on Premenstrual Tension:8 Weeks Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03529721
- Acronym / sponsor ID
- zumba dance
- Conditions
- Premenstrual Tension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zumba dance group | Experimental | Other: zumba dance fitnessfemales 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. |
| non zumba dance group | Placebo comparator | Other: non zumba dancethe control group will be required to carry on doing their normal daily activities throughout the 8-week period. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zumba dance fitnessfemales 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 group |
| non zumba danceAlso: control groupparticipants in this group will be doing their normal daily activities throughout the 8-week period. | Other | non zumba dance group |
Primary outcome
Premenstrual distress questionnaire
Time frame: 3 months after start of zumba dance fitness.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED SAMY, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zumba dance fitness and non zumba dance in people with Premenstrual Tension, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual distress questionnaire (time frame: 3 months after start of zumba dance fitness.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.