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.: PACTR202210882192203 Date of Approval: 06/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Otago exercise programme on falls and fear of falling among older adults in the Community and assisted living facility
Official scientific title Comparative effects of different modes and settings of otago exercise programme on physical and psychosocial functions among older adults
Brief summary describing the background and objectives of the trial Fall and Fear of falling are highly prevalent and can lead to barrage of adverse health conditions among both community-dwelling and assisted-living older adults. Previous Nigerian studies have reported high prevalence of fear of falling, fall incidence, depression and functional disability with reduced physical functioning and quality of life among different older adult populations. The interventions for falls and FOF are tailor-made to suit the populations, environments and cultures for which they were originally developed. Research interest on falls prevention intervention began in the 1970s in developed countries. The available studies were also among community-dwelling older adults with apparently few studies published in this area among older adults living in assisted-living facilities, a group that has been reported to be more adversely affected by falls and FOF than their community-dwelling counterparts. Over time, individually tailored fall prevention exercise programmes have become more common than general programmes. One example of an individually tailored exercise programme is the Otago Exercise Programme The effects of the Otago programme performed in groups on falls and fall risks among older adults living in an assisted living environment are sparsely researched. Most studies on interventions for FOF and fall are from high-income countries, and therefore may not be feasible, acceptable and effective among older adults in developing countries. There is hardly any fall and FOF intervention that is tailor-made to suit older adults in developing countries especially in Africa. This study therefore aims at determining the effects of the OEP on physical and psychosocial functions among community-dwelling and institutionalized older adults, and to compare the Otago Exercise Programme, originally designed as supervised home programme, with the same programme performed as group training, on physical and psychosocial functions, from a Nigerian population
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 30/09/2022
Actual trial start date
Anticipated date of last follow up 15/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Not yet 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
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 multicenter pretest post test quasi experimental 6 months The researcher will randomly allocate the centres into group and individualized interventions. Consequently, the participants will be assigned according to their locations. Baseline scores will be established using the test instruments. The settings will receive the Otago Exercise Programme either in groups or individually, for 8 weeks. The group exercise OEP will be performed in an open, well-spaced area; while the individualized groups will perform the OEP inside their rooms or verandahs. The exercise is estimated to take 30mins and will be prescribed at a frequency of 3 times weekly. The researcher will demonstrate each of the exercises and ask the participants to perform the exercise just after the demonstration to ensure the participants understand how to do the exercise correctly. Ankle weights ranging from 1-4 kg will also be provided according to each participant’s ability, that is, their repetition maximum, to be used with the relevant strengthening exercises 160
Control Group multicentre pretest post test quasi experimental 6 months The researcher will randomly allocate the centres into group and individualized interventions. Consequently, the participants will be assigned according to their locations. Baseline scores will be established using the test instruments. The settings will receive the Otago Exercise Programme either in groups or individually, for 8 weeks. The group exercise OEP will be performed in an open, well-spaced area; while the individualized groups will perform the OEP inside their rooms or verandahs. The exercise is estimated to take 30mins and will be prescribed at a frequency of 3 times weekly. The researcher will demonstrate each of the exercises and ask the participants to perform the exercise just after the demonstration to ensure the participants understand how to do the exercise correctly. Ankle weights ranging from 1-4 kg will also be provided according to each participant’s ability, that is, their repetition maximum, to be used with the relevant strengthening exercises 0 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants will be eligible for inclusion if: i). They are aged 65 years and above ii). They report having fallen at least once in the previous year iii). They report moderate to severe fear of falling on the Short Falls Efficacy Scale International iv). They are residing in this study's locations i). Any medical condition that could interfere with study outcomes ii). Substantial subjective visual or hearing impairments iii). MMSE score less than 24 iv). Inability to walk 3 m v). Require assistance of another person to ambulate or transfer Aged: 65+ Year(s) 65 Year(s) 85 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 28/09/2021 University of Nigeria Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital Enugu Enugu 400102 Nigeria
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 University of Nigeria Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital Enugu 400102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fear of falling will be measured using short form fear efficacy scale international at baseline, three and six months. Fall will be measured by asking participants the participants the number of falls, at baseline, three and six months baseline, 3 months and 6 months
Secondary Outcome Depression will be measured using the Geriatric depression scale at baseline, three and six months. Quality of life will be measured using older people's quality of life questionnaire at baseline, three and six months. Functional mobility will be measured using the time up and go test at baseline, three and six months. Balance will be measured using Berg balance scale. baseline, 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mary mother of Christ compassionate home for the elderly Oguta Road Onitsha Nigeria
St. Joseph Home for the Elderly Nnebisi Road Asaba Nigeria
St vincent de paul home for the elderly and destitute Kpirikpiri Road Abakaliki Nigeria
Nnamdi Azikiwe University Teaching hospital Ukpo and environs Ukpo Awka Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Mgbeojedo Ukamaka Gloria University of Nigeria Enugu Campus Enugu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Medical Rehabilitation Nnamdi Azikiwe University Nnamdi Azikiwe University Nnewi Campus Nnewi Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator UKAMAKA MGBEOJEDO amakaangel1530@gmail.com 2348066761922 University of Nigeria Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria Lecturer UNEC
Role Name Email Phone Street address
Public Enquiries UKAMAKA MGBEOJEDO amakaangel1530@gmail.com +2348066761922 University of Nigeria Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria Lecturer UNEC
Role Name Email Phone Street address
Scientific Enquiries UKAMAKA MGBEOJEDO amakaangel1530@gmail.com +2348066761922 University of Nigeria Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria Lecturer UNEC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be shared Informed Consent Form 1 YEAR access will be open to all
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