Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000116628
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
29/01/2014
Date last updated
3/09/2019
Date data sharing statement initially provided
3/09/2019
Date results provided
3/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Keeping Active using Exercise-based Video Games: a physical activity programme for older people living in rest homes
Scientific title
Among older people living in long term care facilities does a supervised programme of exercise-based video games improve measures of physical performance and activity when compared to usual activities?
Secondary ID [1] 283791 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loss of mobility 290770 0
Physical performance in older people living in long term care facilities 290949 0
Physical activity levels of older people living in long term care facilities 290950 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291134 291134 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will undertake interactive exercise video games using the Xbox Kinect platform, selected and supervised by a study investigator. Sessions will be offered over 8 weeks for approximately 45-60 minutes, twice weekly. Exercise activities will be chosen by a physiotherapist based on the residents’ baseline physical performance measures Activities will include balance and lower limb exercise and also upper limb activities. Activities maybe progressed or varied each session, depending on the individual skill levels.
Although the video games are generally designed for play by 1-2 people, residents of similar ability may be able to join in the activity at one time. Residents may also be able to rest while others do an activity, before joining in again. The group size and precise way the exercise program will be conducted will be dependent on the spread of participants’ abilities as well as the facility’s schedule and physical environment. Participants will be reminded about each session but attendance remains voluntary.
Intervention code [1] 288476 0
Rehabilitation
Intervention code [2] 288477 0
Prevention
Comparator / control treatment
Participants in control facilities will continue usual activities including participation in any activity sessions that they would normally attend.
Control group
Active

Outcomes
Primary outcome [1] 291117 0
The De Morton Mobility Index (DEMMI). The DEMMI is a 15 item test battery measuring physical performance, completed under supervision, which includes transfers, walking and balance tasks scored on a 100-point scale.
Timepoint [1] 291117 0
Baseline and 8 weeks
Primary outcome [2] 291118 0
The Timed Up and Go (TUG). The TUG is a commonly used measure of agility, scored in seconds, which involves rising from a chair, walking 3m at usual pace, turning, walking back and sitting back down.
Timepoint [2] 291118 0
Baseline and 8 weeks
Secondary outcome [1] 306023 0
Habitual activity. Measured using a triaxial accelerometer. The duration of time spent active (in ambulation and standing) and sedentary (sitting and lying down) measured over the waking day, over a 4 day period
Timepoint [1] 306023 0
Baseline and 8 weeks

Eligibility
Key inclusion criteria
Older people living in rest homes who can communicate, transfer and walk independently with or without a walking aid, regardless of cognitive ability, will be eligible to participate.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient vision to see a television screen; and any unstable medical, orthopaedic or neurological condition that would contraindicate participation in an exercise program e.g. acute febrile illness, unstable or acute heart failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A cluster randomised controlled study design will be used, with rest home facilities that consent to participate randomised to either the intervention or the control group. Residents in enrolled facilities will be invited to participate.
After completion of baseline measures of all enrolled residents , the recruitment investigator will telephone the independent investigator holding the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be via a computerised central randomisation service. An independent investigator in a distant site will hold a computer-generated randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimates for this study have been calculated based on the DEMMI outcome measure. Based on existing research, estimated from a baseline mean score on the DEMMI of 42 +/- 15, and an expected minimal clinically important difference of 10 (power = 0.80; 2–tailed with alpha set at 0.05), the sample size required is 72 ( 36 per group). Adjusting for the cluster design effect (cluster size 8, ICC 0.2), 82 would be required. At 20% attrition, the sample size would be 102.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2014
Actual
12/03/2014
Date of last participant enrolment
Anticipated
Actual
5/05/2015
Date of last data collection
Anticipated
Actual
26/06/2015
Sample size
Target
82
Accrual to date
Final
65
Recruitment outside Australia
Country [1] 5688 0
New Zealand
State/province [1] 5688 0
Auckland

Funding & Sponsors
Funding source category [1] 288448 0
University
Name [1] 288448 0
The University of Auckland
Country [1] 288448 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287152 0
None
Name [1] 287152 0
Address [1] 287152 0
Country [1] 287152 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304237 0
University of Auckland Human Ethics Committee
Ethics committee address [1] 304237 0
Ethics committee country [1] 304237 0
New Zealand
Date submitted for ethics approval [1] 304237 0
15/11/2013
Approval date [1] 304237 0
17/12/2013
Ethics approval number [1] 304237 0
010801

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45074 0
Ms Lynne Taylor
Address 45074 0
National Institute for Health Innovation (NIHI)
The University of Auckland
Private Bag 92019
Auckland 1142
Country 45074 0
New Zealand
Phone 45074 0
+64 9 373 7599
Fax 45074 0
Email 45074 0
[email protected]
Contact person for public queries
Name 45075 0
Lynne Taylor
Address 45075 0
National Institute for Health Innovation (NIHI)
The University of Auckland
Private Bag 92019
Auckland 1142
Country 45075 0
New Zealand
Phone 45075 0
+64 9 373 7599
Fax 45075 0
Email 45075 0
[email protected]
Contact person for scientific queries
Name 45076 0
Lynne Taylor
Address 45076 0
National Institute for Health Innovation (NIHI)
The University of Auckland
Private Bag 92019
Auckland 1142
Country 45076 0
New Zealand
Phone 45076 0
+64 9 373 7599
Fax 45076 0
Email 45076 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.