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.: PACTR202309784838404 Date of Approval: 18/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of pilates exercise and spiral taping on premenstrual syndrome
Official scientific title The effect of pilates exercise and spiral taping on premenstrual syndrome
Brief summary describing the background and objectives of the trial Premenstrual syndrome (PMS) affects women’s quality of life, economic and social performance. In other study, about 23- 31 % of reproductive aged women experience PMS to a degree that affects their daily lives Pilates exercise, especially appeal to women across the world, is a flow of exercise which develops physical health (muscle strengthening, endurance, stabilization in core muscles, strengthening in respiratory muscles), psychological health (improved mood, increase in motivation and body awareness) and motor functions (muscle control, dynamic postural control, balance and coordination The aim of study is to: 1) Study the effect of Pilate exercise and spiral taping on menstrual pain and premenstrual syndrome. Significance of the study: Factors such as age, smoking, alcohol and caffeine intake, dietary patterns, oral contraceptives, anthropometirc characteristics, exercise, reproductive and menstrual history and history of sexual abuse were associated with the prevalence of PMS (Masho et al., 2005) . The etiology of PMS is still unknown uncertain, but are likely associated with aberrant responses to normal hormonal fluctuations during the menstrual cycle (Adewuya & Adewumi, 2009). Due to the negative effects of Premenstrual syndrome on an individual’s psychological status, health-related quality of life (HRQoL) may be disrupted among young females (Ju et al., 2014). Furthermore, premenstrual syndrome is a common cause of sickness absenteeism from both classes and work by the female student community (Steiner, 2000). Pilates is a very popular mind and body program widely utilized for health enhancement and treatment of assistance in various diseases (Wells et al., 2012). The exercises are always adapted to the patient's condition, respecting the difficulties, characteristics and abilities of each individual The method is designed for flexibility and range gain,
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 PREMENSTEUAL SYNDROME
Purpose of the trial Rehabilitation
Anticipated trial start date 30/09/2023
Actual trial start date
Anticipated date of last follow up 23/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not 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 from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pilates exercise and spiral taping 3 times per week for 4 weeks starting from 14 days before menstruation and continuing until its end) The girls will perform Pilates exercise 3 times per week for 4 weeks starting from 14 days before menstruation and continuing until its end) and for the spiral taping • 30 girls who will receive Pilates Exercises: comprised of warming up movements for the first 5 min then followed by 30 minutes of basic Pilate's exercises and finally ended by cooling down for the last 5 -7 min. Each session was performed with one to three sets and with 8-12 repetitions per set, and the number of repetitions increased progressively 1st phase included warming up movements for the first 5 min including, standing, roll down and alternate arms. • 2nd phase included 30 minutes of basic Pilate's exercises including single leg lifts, alternate leg lifts, leg circles, single and double leg stretches, spine stretch forward, and pelvic rocking. Breath control will practice during all the exercises. These exercises were selected from the original Pilates exercises because they can be carried out easily without equipment. • 3rd phase included cooling down for the last 5-7 min (movements in sitting and lying down position to return to the initial state) . The girls will perform Pilates exercise 3 times per week for 4 weeks starting from 14 days before menstruation and continuing until its end) and for the spiral taping will be applied to the lower abdomen, the chief complaint area, in order to see if it had any effect on pain alleviation 30
Control Group nonsteroid antiinflammatory drug 3 times per day , and the dose of drug 3 times per day .for 4weeks 30 girls (Group B) will served as experimental control and will received medication (non- steroid anti-inflammatory drug) such as ibuprofen suppress prostaglandin synthetase, and the dose of drug 3 times per day . 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The females will be selected according to the following criteria: 1 -All females will be virginal. 2-Their ages will range from 18-30 years. 3-All socio economical classes were included. 4-They attained menarche and willing to participate in the study. 5- Body mass index <30. 6-They shouldn't have any systemic, chronic or gynecological diseases. 7-whose menstrual pain scores were five or higher on a visual analogue scale (VAS). The potential participants were excluded if they met one of the following criteria : 1. Endometriosis. 2. Pelvic inflammatory diseases. 3-Any pelvic pathological condition 4- use of oral contraceptive. 5-Presence of any diagnosed disease : liver , kidney dysfunction, genital disease 6-Presence of history of pelvic abdominal surgery 7-Diabetic females. 8-females with history of spondoilithesis Adolescent: 13 Year-18 Year 18 Year(s) 25 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 11/12/2022 CAIRO UNIVERSITY RESEARCH ETHICALcommittee
Ethics Committee Address
Street address City Postal code Country
7 AHMED ELZAYAT ST. BIEN ELSARAYAT, DOKKY ,GIZA GIZA 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cortisol level during menstrual cycle
Secondary Outcome degree of menstrual pain : during menstrual cycle
Secondary Outcome premenstrual syndrome before her menstrual blood flow begins
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CAIRO UNIVERSITY 7 AHMED ELZAYAT ST.BIENELSARAYAT .DOKKY.GIZA GIZA 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
YASMEEN RAAFAT AHMED EL RAWDA SHAREFA ST,FROM KHaled IBN waleed ST LUXOR Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university 7 AHMED EL ZAYAT ST BIEN EL SARAYAT , DOKKY , GIZA GIZA 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
yasmeen raafat ahmed sayed el rawda el sharifa st, from KHALED IBN EL WALEED ST ,luxor luxor Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries HALA MOHAMMED HANAFY Emara.hala@yahoo.com +201222105163 FIFTH SETTLEMENT
City Postal code Country Position/Affiliation
CAIRO Egypt professor of physical therapy for women health Faculty of physicaltherapy CAIRO UNIVERSITY
Role Name Email Phone Street address
Principal Investigator YASMEEN RAAFAT AHMED SAYED yasmeen.rafat200@gmail.com +201011498807 el rowda el shrefa ST FROM KHALED IBN WALEED ST
City Postal code Country Position/Affiliation
luxor Egypt physical therapist
Role Name Email Phone Street address
Scientific Enquiries hossam elden hussien kamel Hossameldinsalem.2062@azhar.edu.eg +0201223141816 maser el gededa
City Postal code Country Position/Affiliation
cairo Egypt professor of obstetric and gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in premenstrual syndrome .Data or samples shared will be coded , with no PHI included Approval of the request and execution of all applicable agreements ( i.e material transfer agreement ) are prerequisites to the sharing of data with the requesting party Study Protocol DATA REQUESTS can be submitted starting 9 months after article publication and the data will be made accessible for up 24 months> Extensions will be considered on case by case basis Acess to trial IPD can be requested by qualified researchers engaging in independet scientific research and will be provided following review and approval of a research proposal and STATISTICAL Analysis PLAN (SAP) and execution of a Data Sharing Agreement (DSA)
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