Effect of Brisk Walking on Primary Dysmenorrhea | NCT04852627

Studies
Effect of Brisk Walking on Primary Dysmenorrhea

NCT04852627

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Sep 7, 2022Actual

Enrollment

170Actual

Phase

Not Applicable

Conditions

Dysmenorrhea Primary

Interventions

Brisk walking

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2021Actual

Primary Completion Date

Feb 12, 2022Actual

Completion Date

May 20, 2022Actual

First Submitted Date

Apr 17, 2021

First Submission Date that Met QC Criteria

Apr 17, 2021

First Posted Date

Apr 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2022

Last Update Posted Date

Sep 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise group	Active Comparator	Will brisk walk 30 minutes 3 times weekly	Behavioral: Brisk walking
Control group	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brisk walking	Behavioral	Walking	Exercise group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI: 18-25
regular menstrual cycles

Exclusion Criteria:

Marriage or previous sexual activity
medical disorders
previous abdominal or pelvic surgery
skeletal disorders
hormonal or psychiatric treatment
atheletes

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Must be female

Minimum Age

17 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maii Nawara, MD	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AinShams Maternity Hospital		Cairo		002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD will be available with the principal investigator and will be shared if requested

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided