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.: PACTR202204595180117 Date of Approval: 07/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title community based rehabilitation on older adults
Official scientific title Effect of community-based exercise and educational rehabilitation on older adults
Brief summary describing the background and objectives of the trial 1. Determine and compare the effect of community base rehabilitation exercise and educational programs on memory function of older adults 2. Determine and compare the effect of community base rehabilitation exercise and educational programs on executive function of older adults 3. Determine and compare the effect of community base rehabilitation exercise and educational programs on cognition of older adults 4. Determine and compare the effect of community base rehabilitation exercise and educational programs on depression of older adults 5. Determine and compare the effect of community base rehabilitation exercise and educational programs on mobility of older adults 6. Determine and compare the effect of community base rehabilitation exercise and educational programs on activities of daily living of older adults 7. Determine and compare the effect of community base rehabilitation exercise and educational programs on gait speed of older adults 8. Determine and compare the effect of community base rehabilitation exercise and educational programs on VO2max of older adults 9. Determine and compare the effect of community base rehabilitation exercise and educational programs on grip strength of older adults 10. Determine and compare the effect of community base rehabilitation exercise and educational programs on balance of older adults 11. Determine and compare the effect of community base rehabilitation exercise and educational programs on quality of life of older adults
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COREG STUDY
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/03/2022
Actual trial start date 17/03/2022
Anticipated date of last follow up 30/03/2022
Actual Last follow-up date 01/04/2022
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL scholar.google.com
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control none 8 weeks none 30 Placebo
Experimental Group Exercise and education three times a week 8 weeks participants are given exercise and education three times a week for a period of 8 weeks 90
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Older Adults (65 years and above) that were community dwelling. 2. That were ambulatory with or without walking aids 1. Older adults diagnosed of respiratory disease (e.g., severe asthma, COPD, severe COVID-19 related symptoms) 2. Older adults living in an assisted living facility or nursing home Aged: 65+ Year(s) 65 Year(s) 99 Year(s) Both
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 15/02/2022 Prof. G.N. Adimora
Ethics Committee Address
Street address City Postal code Country
ituku ozalla Enugu 042 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cognition, mobility, activities of daily living, balance week 1, week 4, week 8
Secondary Outcome memory, executive function, depression, gait, VO2 max, grip, quality of life week 1, week 4, week 8
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St Mary Catholic Church Uwani osadebe Street, Uwani Enugu 402106 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
parents and guardian kayentta street Enugu 042 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ngozi Virginia Ezeoba 3 Chief Owen Street Aba 450101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Josephat Ezeoba josyezeoba@gmail.com +2349091096251 kayentta street
City Postal code Country Position/Affiliation
Enugu 042 Nigeria principal investigator
Role Name Email Phone Street address
Scientific Enquiries Obiajuru Isaac josysmart@yahoo.com +2347013163763 Robinson Street
City Postal code Country Position/Affiliation
Enugu 042 Nigeria scientific Enquiry
Role Name Email Phone Street address
Public Enquiries Emeka Chukwuma jaychuks03@gmail.com +2349157379021 UNEC
City Postal code Country Position/Affiliation
Enugu 042 Nigeria public inquiry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available, individual participant data that underlie the results Reported in this article, after de-identification (text, tables, figures, And appendices). Study protocol, statistical analysis plan, informed consent form, clinical study report and Analytic code will also be available. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 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