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.: PACTR201905728440442 Date of Approval: 06/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Aerobic Exercise on Plasma Oxytocin in Depressed Post-menopausal Women: A Randomized Controlled Trial
Official scientific title Effect of Aerobic Exercise on Plasma Oxytocin in Depressed Post-menopausal Women: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial It is well documented that exercise helps alleviate menopausal and depressive symptoms in middle-aged as well as post-menopausal women, butsufficient evidence does not currently exist to fully support the effect of aerobic exercise on plasma oxytocin levels. Therefore,this trial will aim to examine the effect of a 4-week aerobic exercise program on plasma oxytocin levels in depressed post-menopausal women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BMI
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/04/2019
Actual trial start date 15/04/2019
Anticipated date of last follow up 20/05/2019
Actual Last follow-up date 01/06/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group aerobic exercise in form of treadmil exercises plus daighragmatic breasthing exercises 3 session per week 30 minute per session , 3 session per week for 4 weeks plus daighragmatic breasthing exercise 3 sessions per week for 4 weeks 20 depressed post-menopausal women will receive diaphragmatic breathing exercises 30 minute per session , 3 session per week for 4 weeks in addition to a program of aerobic exercise using treadmill for another 30 minute per session , 3 session per week for 4 weeks. 20
Control Group diaphragmatic breathing 3 session per week 30 minute per session , 3 session per week for 6 weeks twenty depressed post-menopausal women will receive diaphragmatic breathing (only) 30 minute per session , 3 session per week for 4 weeks 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Post-menopausal women with severe depression. 2. Their age will range from 45 to 60 years old. 3. Their BMI will be less than 30 Kg/m2. 4. They experience menopause naturally. 5. All of them will be at a minimum of 2 years after the last menstruation. 1. Post-menopausal women having chronic diseases within the last 5 years, including diabetes, hypertension, cardiac diseases, diseases of the thyroid gland, active cancerous disease, medical history of mental diseases, neurological or musculoskeletal disorder, and addiction to drugs and/or alcohol. 2. Post-menopausal women having chronic musculoskeletal problems such as knee joint osteoarthritis, ankle joint deformities, or lower back pain in the previous 6months Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 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 03/03/2019 PT REC
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Dokky, Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome plasma oxytocin levels at the begining of the study and after the end of the study 4 weeks
Secondary Outcome Hamilton Depression Scale to assess the severity of depression at the begining of the study and after the end of the study 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
OUT CLINIC OF FACULITY OF PHYSICAL THERAPY UNIVERSITY STREET GIZA 3455 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
afaf mohamed botla Sendpeace, Gamal Abd Al Naser Street Al Qanater Al Khayria 1122 Egypt
Doaa ahmed mohamed osman El Mareria street El Materia 3645 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FACULITY OF PHYSICAL THERAPY UNIVERSITY STREET Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Doaa Ahmed Mohamed Osman El Mareria street El Materia 3645 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Afaf Botla drafafmohamed@yahoo.com 01283126608 Gamal abd el naser street
City Postal code Country Position/Affiliation
El Kanater El Khairia 1122 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Doaa Osman drdoaaosman@yahoo.com 02201115792245 El Matarria street
City Postal code Country Position/Affiliation
El Matarria 3645 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Afaf Botla drafafmohamed@yahoo.com 01283126608 Sendpeace, Gamal Abd Al Naser Street.
City Postal code Country Position/Affiliation
El Kanater El Khaeria 1122 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All information including age, date of last menstrual period , weight , height and body mass index and also all measuring variables including plasma oxytocin levels and the severity of depression measured by Hamilton Depression Scale will be collected for each participant. Also the letter of ethical committee and consent form will be available Analytic Code,Clinical Study Report,Statistical Analysis Plan,Study Protocol Within 12 months following the publication The individual participant data will be available at our organization (Cairo University, Bluttin of faculty of physical therapy) through a request from the organization that want the IPD for reanalysis, this request will be reviewed by the organization membership for acceptance.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www. bfpt.eg.net 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