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.: PACTR202008547335106 Date of Approval: 20/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of interactive video gaming in older adults with memory complaints
Official scientific title Efficacy of interactive video gaming in older adults with memory complaints
Brief summary describing the background and objectives of the trial The effects of aging on physical and mental health may be ameliorated by regular participation in physical activity (PA). There is also evidence for the benefits of various training modalities on cognition and functional ability in older adults. The aim of this study was to compare effects of a 12-week active video gaming intervention (X Box Kinect Sports) to conventional multimodal supervised exercise on fitness, functional ability and cognitive performance in older adults with memory complaints
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Memory Complaints
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 02/05/2016
Actual trial start date 02/05/2016
Anticipated date of last follow up 02/12/2016
Actual Last follow-up date 01/12/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 45
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Interactive Video Gaming 1 hour, twice a week for 12 weeks 12 weeks Participants in the intervention group attended two, one hour interactive video game (IVG) sessions per week. The IVG sessions took place at the respective retirement homes for the duration of the 3 month program. The X-Box Kinect Sports video gaming software was used and comprises of 6 games namely: ten-pin bowling, boxing, track and field, table tennis, beach volleyball and soccer. The participants played each of the 6 games at each session with a partner and two pairs played (n=4) per session. The first pair played the game for 15 minutes while the second pair rested after which the roles were reversed. Therefore, each pair played for a total of 30 minutes and had 30 minutes break per session. 23
Control Group Conventional Multimodal Supervised Exercise 1 hour , twice a week for 12 weeks 12 weeks The comparison group met for one hour, twice per week, for 12 weeks and participated in group-based low intensity conventional multimodal supervised exercise sessions. The exercise program consisted of a combination of standing and seated exercises. The exercise sessions comprised of a 10 minute warm up, 30 minutes of strength training, followed by 10 minutes of proprioceptive exercises and 10 minutes of cooling down. All exercises were performed using body weight only for the first 6 weeks. The intensity of the upper body strength training exercises for weeks 7 to 12 were increased by using plastic soft drink bottles (500ml) filled with sand as weights. Participants enjoyed a 45 second break after each set of exercises for the duration of the 12 weeks. Each set consisted of 15 repetitions per an exercise 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals aged 65 years and older with subjective and objective memory complaints and residing in a retirement home were eligible. We adapted the Petersen criterion for MCI to determine subjective and objective memory complaints in older adults not clinically diagnosed with MCI. Individuals were eligible to participate in the study if they met all 5 of the criteria Subjective memory complaints, Objective memory impairment, Intact daily function, Normal cognitive function (Adapted Telephone Interview for Cognitive Status (TICS)) and Non-demented) Older adults who had been previously diagnosed with a stroke, Parkinson’s disease, balance disorders, impaired vision or had uncontrolled conditions such as hypertension (blood pressure more than 160/90 and not on medication) or diabetes (not on medication) were excluded from the study. Those with orthopaedic injuries which inhibited normal locomotion were also excluded. The Physical Activity Readiness Questionnaire (PAR-Q) was used as the first line of screening for participant’s entry into the study. Those who were identified as being at an increased risk for coronary artery disease, according to the American College of Sports Medicine (ACSM) criteria, required consent from a doctor to allow them to participate. 80 and over: 80+ Year,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 09/03/2016 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Old Main Building, Groote Schuur Hospital Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Global Cognitive Function Baseline and 12 weeks
Secondary Outcome Executive Function Baseline and 12 weeks
Secondary Outcome Working Memory Baseline and 12 weeks
Secondary Outcome 6 Minute Walk test Baseline and 12 weeks
Secondary Outcome Dynamic Balance Baseline and 12 weeks
Secondary Outcome Timed Up and Go test Baseline and 12 weeks
Secondary Outcome Functional Reach test Baseline and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cape Peninsula Organization for the Aged 231 Main Road, Newlands Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Estelle Victoria Lambert Boundary Road, Newlands Cape Town 7700 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Residence Road Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
University of South Queensland 11 Salisbury Road Ipswich Queensland 4305 Australia
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Udhir Ramnath rmnudh001@myuct.ac.za +27738000973 Boundary Road
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Student
Role Name Email Phone Street address
Scientific Enquiries Estelle Victoria Lambert vicki.lambert@uct.ac.za +27823126890 Boundary Road
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Head of Department
Role Name Email Phone Street address
Principal Investigator Udhir Ramnath rmnudh001@myuct.ac.za +27738000973 Boundary Roaad
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Student
Role Name Email Phone Street address
Principal Investigator Tracy KolbeAlexander tracy.kolbe-alexander@usq.edu.au +610474063075 11 Salisbury Road
City Postal code Country Position/Affiliation
Ipswich Queensland 4305 Australia Associate Head of School Research and Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 20/08/2020
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