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.: PACTR202203522660189 Date of Approval: 17/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Efficacy of Core Stability and Otago Exercise on Balance and Fall Prevention in Community-Dwelling Elderly Following Delayed Transversus Abdominis Activation
Official scientific title Comparative Efficacy of Core Stability and Otago Exercise on Balance and Fall Prevention in Community-Dwelling Elderly Following Delayed Transversus Abdominis Activation
Brief summary describing the background and objectives of the trial Fall related injury in the elderly has been recognized as a major public health issue.The value of independence in the elderly cannot be over-emphasized as a fall can drastically reduce their ability to self-care and limit participation in physical activities and social participation. Falls are the leading cause of unintentional injury-related deaths and non-fatal injuries in people aged 65 years and older, constituting 55 percent of all cases. Falls predispose to injury, loss of independence, decreased mobility, hospitalization, nursing home placement, reduction in the quality of life, and early death. The overall aim of this study is to investigate the comparative efficacy of core stability exercises and the Otago exercise programme on balance and fall prevention in community dwelling elderly following delayed activation of the transversus abdominis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Fall Prevention
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 14/03/2022
Actual trial start date
Anticipated date of last follow up 14/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status 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 created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Core stabilty exercise Three times weekly Two months Abdominal draw in maneuver(ADIM) of 3 sets of 10 contractions with a 10 seconds hold and 15 seconds rest. Also, core stability side-bridge exercise as well as core stability quadruped exercise of the same set as the ADIM 20
Experimental Group Otago exercise programme Three times weekly with once weekly home visit 2 months 5 warm exercises, 5 strengthening exercises and 12 balance exercises 20
Control Group Control Three times weekly 2 months The better outcome between the core stability and otago exercise protocol will be given to the control group at the end of data analysis 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults who are 65 years and older Adults who can walk independently with or without a walking aid Participants who are unable to walk 3 meters Participants that cannot understand basic instructions Aged: 65+ Year(s) 65 Year(s) 90 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 08/02/2022 University of Ilorin teaching hospital ethics review committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, Oke-Ose, P.M.B. 1459, Ilorin. Kwara State. Nigeria Ilorin 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 30 second chair rise At baseline and at the end of the 2 months
Primary Outcome Timed Up and Go Test At baseline and at the end of two months programmes
Primary Outcome Four stage balance test At baseline and at the end of the two months programme
Secondary Outcome Fall prevention At baseline and at the end of the 2 month programme
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Communities in Ilorin south and Ilorin west Tanke ile iwe community Health Centre, Tanke Ilorin 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Jogunola Olabanji Plot 5, Agric GRA Ilorin 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Olabanji Jogunola Plot 5, Agric GRA Ilorin 23401 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olabanji Jogunola ollyb555@gmail.com +2348036068328 Plot 5, Agric GRA
City Postal code Country Position/Affiliation
Ilorin 23401 Nigeria Assistant Director Physiotherapy. Physiotherapy Department. University of Ilorin Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Olabanji Jogunola ollyb555@gmail.com +2348036068328 Plot 5, Agric GRA
City Postal code Country Position/Affiliation
Ilorin 23401 Nigeria Assistant Director Physiotherapy. Physiotherapy Department. University of Ilorin Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Olabanji Jogunola ollyb555@gmail.com +2348036068328 Plot 5, Agric GRA
City Postal code Country Position/Affiliation
Ilorin 23401 Nigeria Assistant Director Physiotherapy. Physiotherapy Department. University of Ilorin Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be made available in a maximum of a year after completion of the research Clinical Study Report,Informed Consent Form 1 year Controlled access to requesting data information and also depending on the quality of the request
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