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.: PACTR201908589835132 Date of Approval: 26/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Premenstrual syndrome and exercises
Official scientific title Effect of resistive exercise versus whole body vibration on premenstrual syndrome
Brief summary describing the background and objectives of the trial Premenstrual syndrome (PMS) is characterized by a cyclic occurrence of intense physical, cognitive, behavioral and somatic symptoms in the luteal phase of the menstrual cycle. These symptoms interfere with normal activities, reduces work efficiency and educational productivity, incresase absenteesism from school and disturb interpersonal relationship and social activities. In recent years, there has been a focus on finding accessible, acceptable, and cost-effective therapeutic approaches with minimal side effects to treat the symptoms of PMS
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 Premenstrual syndrome
Purpose of the trial Treatment: Devices
Anticipated trial start date 29/04/2014
Actual trial start date 01/05/2014
Anticipated date of last follow up 29/10/2014
Actual Last follow-up date 29/10/2014
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Resistive exercise 3 sessions/week 12 weeks Resistive exercise was started with 5-10 minutes warm up phase and ended with 5-10 minutes cool down phase, which consisted of stretching exercises for the upper and lower limbs. The exercise circuit for the upper limb consisted of exercises to the shoulder and elbow joints; while the exercise circuit for the lower limb consisted of hip and knee joints.One exercise circuit was performed for each limb. One repition maximum (1RM) was determined for a given exercise. Then, the weight lifted was estimated as follows: 30% to 40% of 1 RM for the upper limb and 50% to 60% of 1 RM for the lower limb. Each exercise was performed for 3-4 repetitions, which was increased gradually untill 10 repetitions. Each participant rested 2 minutes between each exercise. The total session duration was 40 minutes. 15 Active-Treatment of Control Group
Experimental Group whole body vibration 3 sessions/week 12 weeks Each participant performed the WBV exercise on Confidence Vibration Plate Power Plus, which produced a lateral peak-to-peak oscilltation. They stood on WBV platform with a 150° knee angle (slight flexion) during the exposure minute. They started the WBV training with 3 sets of 1 minute separated by 1 minute resting period and a vibration amplitude 1mm. The training load was increased by one set every session untill 10 sets of WBV was completed. The frequency was started with 20 HZ, then it was increased gradually by 2 HZ every 2 weeks 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants ages ranged from 16-20 years and their body mass index was <19.9kg/m2. They experienced regular menstrual cycles. They were diagnosed with PMS according to PMS questionnaire. Females with the following criteria were excluded including a history of pelvic pathology, pelvic inflammatory diseases, endometriosis, cardiac diseases, thyroid diseases, taking oral contraceptive pills, or smoking. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 20 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 29/04/2014 Research Ethics Board
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ElZayat st., Been ElSarayat, Dokki Giza 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Premenstrual symptoms including anxiety, depression, hyper hydration, craving and other symptoms, cramp and low back pain At starting of the study and after 12 weeks of the study course
Primary Outcome Estradiol At starting of the study and after 12 weeks of the treatment course
Primary Outcome Progesterone At starting of the study and after 12 weeks of the treatment course
Primary Outcome Prolactin At starting of the study and after 12 weeks of the treatment course
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafer El zyat Nursing School and Faculty of Physical Therapy 7 Ahmed Elzayat st., Been ElSarayat, Dokki, Giza Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sanaa Abdalla 7Ahmed Elzayat st. Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy 7 Ahmed ElZayat st., Been ElSaryat Giza 12622 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sanaa Abdallah 7Ahmed ElZayat st., Been Elsarayat Giza 12622 Egypt
Abeer ElDeeb 7Ahmed ElZayat st., Been Elsarayat Giza 12622 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abeer ElDeeb beroeldeeb@yahoo.com 00201001811588 7Ahmed ElZayat st., Been ElSarayat
City Postal code Country Position/Affiliation
Giza 12622 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Abeer ElDeeb beroeldeeb@yahoo.com 00201001811588 7Ahmed ElZayat st., Been ElSarayat
City Postal code Country Position/Affiliation
Giza 12622 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Abeer ElDeeb beroeldeeb@yahoo.com 00201001811588 7Ahmed ElZayat st., Been ElSarayat
City Postal code Country Position/Affiliation
Giza 12622 Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants data that underlie results reported in the article published will be available Informed Consent Form Begining 9 months and ends 36 months after publication of the article. It will be provided for researchers who provide a methodologically sound protocol for meta analysis.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Results revealed that the resistive group showed a highly significant decrease in premenstrual symptoms score (p=0.0001), progesterone (p=0.0001), prolactin (p=0.0001) and significant decrease in estradiol (p=0.004) post treatment. While WBV group showed a highly significant decrease in premenstrual symptoms score (p=0.0001), prolactin (p=0.001)and a significant decrease in estradiol (p=.042), progesterone (p=0.039) post-treatment. However, resistive group showed a highly significant decrease in premenstrual symptoms score (p=0.0019) and a significant decrease in estradiol (p=0.0027), progesterone (p=0.046) and prolactin (p=0.042) when compared to WBV group. 23/08/2015 23/08/2015
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://lib.pt.cu.edu.eg/data%20Gynaecology%20master%202015.pdf
Changes to trial information