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.: PACTR202204891870392 Date of Approval: 04/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Physiotherapy
Official scientific title THE EFFECTS OF EXERCISE ON THE HEALTH PROFILE OF POSTMENOPAUSAL WOMEN
Brief summary describing the background and objectives of the trial Menopause is the permanent cessation of menstruation which is retrospectively determined following twelve months of amenorrhea during midlife period. The human aging process is accompanied by a significant decline in musculoskeletal, neuromuscular functions and performance. Menopause occurs due to decline in the production of ovarian gonadotropin, Estrogen. Menopausal Transition is accompanied by metabolic changes and increasing prevalence of metabolic changes and syndrome, hot flushes, decline in cognition, high blood pressure, dyspnea, vagina dryness, loss of scalp hair and depression. Brisk walking exercise reduce bone loss in postmenopausal women and regular physical activities extend and improve quality of life. To effectively understand the effects of exercise on the health profile of post menopausal women, this clinical trials is needed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PP
Disease(s) or condition(s) being studied Circulatory System,Mental and Behavioural Disorders,Musculoskeletal Diseases,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 31/03/2022
Actual trial start date 01/04/2022
Anticipated date of last follow up 13/05/2022
Actual Last follow-up date 13/05/2022
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling 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 Exercise group For 6 weeks 5 minutes The brisk walking exercise will start from 5 minutes and will be progressed to 10 the following week. It will be progressing by 5 minutes every week. 75
Control Group Control None 6weeks Their data will be collected in the pre trial phase. 75 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Postmenopausal women, irrespective of state of origin,race, local government Postmenopausal women who are in estrogen therapy Aged: 65+ Year(s) 60 Year(s) 200 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 03/10/2022 Prof G.N Adimora
Ethics Committee Address
Street address City Postal code Country
ITUKU OZALLA ENUGU 01129 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To find the effects of exercise on the blood pressure 5minutes
Primary Outcome The effects of exercise on balance 10 minutes
Primary Outcome The effects of exercise on the pulse rates, respiratory rates and hand grip strength of post menopausal women 10 minutes
Primary Outcome The effects of exercise on the cognition and psychosocial wellbeing, 10 minutes
Secondary Outcome To find the association between age and responsiveness to physical activities 5 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St Mary Catholic church Enugu Uwani Enugu Enugu 400102 Nigeria
St Joseph Catholic church Emene Awkunanaw street ENUGU 400102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ojielo CHUKWUEBUKA 4b ilukwe street Asata ENUGU 400102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OJIELO Getrude ifeyinwa 4b ilukwe street Asata Enugu Enugu 400102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chukwuebuka OJIELO dinanebuka@gmail.com +2348167796323 4b ilukwe street Asata Enugu
City Postal code Country Position/Affiliation
ENUGU 400102 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Valentine Arinze arinzevalentine345@gmail.com +2348023009385 37 Udoji street ENUGU
City Postal code Country Position/Affiliation
ENUGU 400102 Nigeria Coordinator
Role Name Email Phone Street address
Scientific Enquiries Cynthia Ijeoma cynthybliss94@gmail.com +2349064940562 45 presidential road, ENUGU
City Postal code Country Position/Affiliation
ENUGU 400102 Nigeria Research assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individuals participant data will be available including data dictionaries. The data that will be shared is the participant data that underlie the results Reported in the article, after de-identification, study protocol, statistical analysis, informed consent form, clinical study report and Analytic code. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be available immediately following publication No end date Anyone who wishes to access the data
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