Dysmenorrhea PrimaryNCT04852627
Effect of Brisk Walking on Primary Dysmenorrhea
A study testing Brisk walking in people with Dysmenorrhea Primary, run by Ain Shams University at 1 site in Egypt.
Trial summary
Dysmenorrhea is a common problem in women. Exercise is commonly cited as a possible remedy. We will measure the effect of brisk walking on primary dysmenorrhea among medical students. Read more about this study
- Who is it for?
- Ages 17 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Brisk walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Apr 2021to 20 May 2022
- 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 17 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- BMI: 18-25
- regular menstrual cycles
Who cannot join
- Marriage or previous sexual activity
- medical disorders
- previous abdominal or pelvic surgery
- skeletal disorders
- hormonal or psychiatric treatment
- atheletes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Brisk Walking on Primary Dysmenorrhea Among Medical Students
Dysmenorrhea is a common problem in women. Exercise is commonly cited as a possible remedy. We will measure the effect of brisk walking on primary dysmenorrhea among medical students.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Brisk walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brisk walkingBehavioural
Walking
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Active comparator | Will brisk walk 30 minutes 3 times weekly Receives: Behavioral: Brisk walking |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysmenorrhea score
WaLIDD (working ability, location, intensity, days of pin, dysmenorrhea)score for dysmenorrhea. Least is 0, highest is 12. The higher the score, the worse dysmenorrhea
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start24 Apr 2021
- Primary completion12 Feb 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maii Nawara, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852627
- Sponsor's protocol ID
- M D 59/2021
- Status last verified
- Sep 2022
- First submitted
- 17 Apr 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available with the principal investigator and will be shared if requested
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brisk Walking on Primary Dysmenorrhea Among Medical Students
- ClinicalTrials.gov ID
- NCT04852627
- Acronym / sponsor ID
- M D 59/2021
- Conditions
- Dysmenorrhea Primary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Apr 2021 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 21 Apr 2021 (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.
Dysmenorrhea is a common problem in women. Exercise is commonly cited as a possible remedy. We will measure the effect of brisk walking on primary dysmenorrhea among medical students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Active comparator | Behavioral: Brisk walkingWill brisk walk 30 minutes 3 times weekly |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- BMI: 18-25
- regular menstrual cycles
Key exclusion criteria (6 listed)
- Marriage or previous sexual activity
- medical disorders
- previous abdominal or pelvic surgery
- skeletal disorders
- hormonal or psychiatric treatment
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 |
|---|---|---|
| Brisk walkingWalking | Behavioural | Exercise group |
Primary outcome
Dysmenorrhea score
Time frame: 3 months
WaLIDD (working ability, location, intensity, days of pin, dysmenorrhea)score for dysmenorrhea. Least is 0, highest is 12. The higher the score, the worse dysmenorrhea
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 7 Sep 2022.
- Individual participant dataSharing planned: Yes. IPD will be available with the principal investigator and will be shared if requested
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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.
Maii Nawara, MD principal investigator
Ain Shams 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 Brisk walking in people with Dysmenorrhea Primary, run by Ain Shams 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 2 inclusion and 6 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 7 Sep 2022. 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. 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?
Dysmenorrhea score (time frame: 3 months). 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 7 Sep 2022.