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.: PACTR201603001513802 Date of Approval: 07/03/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Exercise-based fall prevention interventions: Wii Fit vs. Otago
Official scientific title The feasibility and potential effectiveness of a conventional and video exercise based intervention to alter balance related outcomes including fall risk: a mixed methods study
Brief summary describing the background and objectives of the trial Background: falls are prevalent in older adults and costly in personal and public health terms. Exercise-based interventions are effective but resource-intensive. Could video exergaming have an effect in a real-world setting? Aims: a feasibility study comparing a conventional fall prevention programme (OEP) vs. Wii Fit. A process, resource and management assessment will assess the feasibility of a large scale clinical trial. Early scientific evidence will also be sought in terms of intervention safety, dose and effect of each programme. Interventions will be randomly allocated to clusters. Clusters will be residential communities of independent older adults. Single blinding will be utilised.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Fall risk in older adults,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 29/04/2016
Actual trial start date 19/12/2016
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date 31/05/2018
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 58
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
818/2015 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
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 randomisation of clusters Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Wii Fit Balance Board 52 hours six months warm up exercises, progressive Wii Fit exergames, cool down exercises, walking programme 50
Experimental Group Otago Exercise Programme 52 hours six months balance and strength exercises, general conditioning, walking programme 50
Experimental Group Costs-analysis only group regular care six months regular care 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 years or older defined fall risk (e.g. previous fall/suggested by measures of balance and gait/two or more chronic illnesses/three or more chronic medications) living independently in retirement community stand and walk without assistance not planning absence of more than three weeks in first six months willing to exercise as prescribed willing to keep records as per protocol willing to undergo outcome measures including self-assessment scales access to stable electricity and television contactable by phone or email able to follow instruction Cardiac pacemaker Epilepsy Waist circumference which precludes use of gait belt orthopaedic surgery within last six months regular participation in rehabilitation programme decreased cognitive function mass >150kg restricted upper limb mobility in dominant hand restricted/absent lower limb mobility including assistive device severely reduced visual acuity severely reduced auditory acuity 60 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 02/03/2016 Univeristy of Cape Town Faculty of Health Sciences Human Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Room E52-24, D Floor, Old Main Building, Groote Schuur Hospital Observatory Cape Town 7925 South Africa
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 07/04/2017 University of Cape Town Faculty of Health Science Human Reserch Ethics committee
Ethics Committee Address
Street address City Postal code Country
Clinical Research Centre, L51 Old Main Building, Groote Schuur Hospital Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome feasibility indicators as described above Done at 3 and 6 months only
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fernbridge Alanwyck Road Diep River Cape Town 7800 South Africa
Riverside Place Alanwyck Road, Diepriver Cape Town 7800 South Africa
Alphenvale Retirement village Parish Road, Constantia Cape Town 7800 South Africa
Bergridge Park Edison Drive, Bergvliet Cape Town 7800 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Univeristy of Cape Town Department of Health and Rehabiitation Sciences, F Floor, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Harry Crossley Fellowship 2017 University of Cape Town Cape Town 7925 South Africa
National Research Foundation Box 2600 Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Delva Shamley Clinical Research Centre, L51 Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Seyi Amosun Division of Physiotherapy, Department of Health and Rehabilitation Sciences, F Floor, Old Main Building, Groote Schuur Hospital Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Delva Shamley Delva.Shamley@uct.ac.za 0743775287 L51 Old Main Building Groote Schuur Hospital Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Principal investigator
Role Name Email Phone Street address
Public Enquiries Peter Rogers progers@cybersmart.co.za 0217120402 13a Windsor Avenue Diep River
City Postal code Country Position/Affiliation
Cape Town 7800 South Africa PRO
Role Name Email Phone Street address
Scientific Enquiries Christine Rogers Christine.Rogers@uct.ac.za 0214066315 13a Windsor Avenue Diep River
City Postal code Country Position/Affiliation
Cape Town 7800 South Africa Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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