Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901684344569 Date of Approval: 14/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title effect of different squatting exercises on primary dysmenorrhea
Official scientific title effect of different squatting exercises on primary dysmenorrhea
Brief summary describing the background and objectives of the trial the trial attempts to investigate the effect of different types of squatting exercises on menstrual symptoms. squatting exercises are assumed to improve the circulation and consequently, decrease pelvic congestion that causes menstrual symptoms. squatting exercises may exert their effect on circulation through changing pelvic mechanics.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied primary dymenorrhea
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 20/01/2019
Actual trial start date
Anticipated date of last follow up 19/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group yoga 2 times per week for 3 consecutive menstrual cycles. 30 minutes per day the female is asked to perform 3 yoga poses (cobra, cat and fish) at her luteal phase for 30 minutes twice a week for 3 consecutive menstrual cycles 30 Active-Treatment of Control Group
Experimental Group modified wall squat 3 times/ week for 3 months , over 3 consecutive menstrual cycles. 30 minutes The female will be asked to stand against a wall with both legs shoulder - width apart and at a distance of one foot from the wall. The chin will be pulled in with both pelvis and lumbar spine in neutral position. Knees will be flexed to 90° and maintain that position for 5 seconds then the knees will be extended back to 10° for 3 seconds. This will count as a one motion and 10 motions will be considered as one set. a total of 5 sets will be done with 15 seconds rest in between sets. 30
Experimental Group Sumo squat 3 times/week for 3 months (over 3 consecutive menstrual cycles). Begin by 5 minutes and gradually increase till maximum of 30 minutes. The female will be asked to stand with feet a bit wider than shoulder - width as starting position then squat by pulling hips down trying to keep chest up and out. Once squatting deep enough, descent is stopped and reverse back up is done. This will be counted as one motion and 10 motions will be counted as one set. a total of 5 sets will be done with 15 seconds rest in between sets. 30
Experimental Group Deep squat 3 times /week for 3 months (over 3 consecutive menstrual cycles) Maximum of 30 minutes With keeping back straight, spine neutral and both chest and shoulders up, the female will be asked to squat down while squeezing glutes focusing on keeping knees in line with the feet till hip joints are lower than knees. Once reaching deep enough, reverse standing back up is done. This is one motion and 10 motions will be counted as one set. A total of 5 sets will be done with 15 seconds rest in between sets. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- single females suffering from primary dysmenorrhea with normal menstrual cycles. 2- their age ranging from 19-35. 3- their body mass index ranging from 19-29 kg/ m2. 4- having no history of any pelvic disease. 5- the are not receiving any hormonal therapy or taking any regular drugs during the menstrual cycle preceding the intervention. any participant will be excluded if she has one or more of the following: 1- history of any cardiovascular, respiratory liver, kidney or uncontrolled hypertension. 2- having any reproductive disorders or pelvic pathology (endometriosis, PCOS....). 3- 19>BMI>40 kg/m2. 4- limited lower limb mobility, bone disease or inability to tolerate exercise. 5- performing any other exercises during treatment interval. 6- married females. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 19 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/05/2018 Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza 12625 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement in menstrual symptoms at start of the menstrual cycle before intervention and at the start of the next two menstrual cycles after intervention
Secondary Outcome effect on circulation at start of the menstrual cycle before intervention and at the start of the next two menstrual cycles after intervention
Primary Outcome pain intensity at start of the menstrual cycle before intervention and at the start of the next two menstrual cycles after intervention
Secondary Outcome pelvic angle at start of the menstrual cycle before intervention and at the start of the next two menstrual cycles after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7, Ahmed el Ziat street , ben el tharayat Giza 12625 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahitab Mohamed Yosri faculty of physical therapy, cairo university Giza 12625 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mahitab Mohamed Yosri faculty of physical therapy, cairo university Giza 12625 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amal Mohamed Yousef faculty of physical therapy, cairo university Giza 12625 Egypt
Marwa Abdel Rahman Mohamed faculty of physical therapy, cairo university Giza 12625 Egypt
Hamada Ahmed Hamada faculty of physical therapy, cairo university Giza 12625 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries hamada hamada hamada.ahmed@pt.cu.edu.eg 00201117893697 Faculty of physical therapy, Cairo University
City Postal code Country Position/Affiliation
Cairo 12625 Egypt Lecturer of Biomechanics
Role Name Email Phone Street address
Public Enquiries Hamada Hamada hamada.ahmed@pt.cu.edu.eg 00201117893697 Faculty of physical therapy, Cairo University
City Postal code Country Position/Affiliation
Cairo 12625 Egypt Lecturer of Biomechanics
Role Name Email Phone Street address
Principal Investigator mahitab yosri mahyyosri2010@gmail.com 00201222606996 faculty of physical therapy, cairo university
City Postal code Country Position/Affiliation
cairo 12625 Egypt assistant lecturer of women s health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information