Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000016639
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
7/01/2014
Date last updated
11/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can interventions that aim to promote physical activity and prevent falls be combined successfully to improve mobility and independence in older age?
Scientific title
What is the effect of a physical activity promotion and fall prevention intervention compared to an advice brochure on physical activity participation, mobility goal attainment and falls in older, community-dwelling adults?
Secondary ID [1] 283662 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 290616 0
Physical activity participation 290617 0
Condition category
Condition code
Injuries and Accidents 291008 291008 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 291153 291153 0 0
Other physical medicine / rehabilitation
Public Health 291154 291154 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention aims to increase physical activity participation and reduce risk of falling. It involves a fall risk assessment, tailored fall prevention and physical activity counselling using health coaching and a pedometer-based intervention enhanced with a web-interface (using the "fitbit") to provide feedback and encouragement. The intervention components mentioned above will be delivered by the research physiotherapist during one home visit, lasting approximately two hours. Participants will be encouraged to wear the pedometer during waking hours on a daily basis for the whole six months to record their daily steps and provide feedback and motivation to increase their physical activity participation. An ultimate goal of undertaking 10,000 steps/ day will be the target. The "fitbit" enhanced pedometer is designed to wirelessly synchronise with computer software to download stored physical activity information and participants will be encouraged to synchronise and download their data on a weekly basis or more often if they desire to. During the implementation of the intervention participants will be taught how to use the "fitbit" device and the associated internet-based feedback and monitoring technology. The research team will have access to all intervention participants "fitbit" data and will monitor individual adherence with the intervention. People who have not downloaded their "fitbit" data in the past week will be contacted to enquire about any problems encountered with the pedometer and to encourage compliance with the intervention protocol.
Intervention code [1] 288369 0
Lifestyle
Intervention code [2] 288370 0
Prevention
Intervention code [3] 288494 0
Behaviour
Comparator / control treatment
The control group will receive the Staying Active and On Your Feet booklet developed by the NSW Ministry of Health and will be advised to continue their usual activities including any health service contact so will not be disadvantaged by being in the study.
Control group
Active

Outcomes
Primary outcome [1] 291001 0
Physical activity participation, assessed over a 7-day period using the Actigraph accelerometer
Timepoint [1] 291001 0
Six and 12 months after randomisation
Primary outcome [2] 291002 0
Mobility goal attainment will be assessed using the Goal Attainment Scale.
Timepoint [2] 291002 0
Six and 12 months after randomisation
Secondary outcome [1] 305794 0
The proportion of people meeting physical activity guidelines of 150 minutes per week of moderate to vigorous physical activity (from the Actigraph)
Timepoint [1] 305794 0
Six and 12 months after randomisation
Secondary outcome [2] 305795 0
Quality of life will be assessed with the EQ-5D.
Timepoint [2] 305795 0
Six and 12 months after randomisation
Secondary outcome [3] 305796 0
Fear of falling will be assessed using the short-form Falls Efficacy Scale International
Timepoint [3] 305796 0
Six and 12 months after randomisation
Secondary outcome [4] 305797 0
Mood will be assessed with the positive sub-scale of the Positive and Negative Affect Scale
Timepoint [4] 305797 0
Six and 12 months after randomisation
Secondary outcome [5] 305799 0
Mobility disability will be assessed using the Late Life Function and Disability Index
Timepoint [5] 305799 0
Six and 12 months after randomisation
Secondary outcome [6] 312171 0
Falls- recorded with monthly postal calendars
Timepoint [6] 312171 0
12 months after randomisation

Eligibility
Key inclusion criteria
-aged 60+
-living at home
-regular (weekly) use of a computer or internet-connected tablet device
-leaves the house regularly (at least once per week) without physical assistance from another person.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
being “house-bound” -cognitive impairment (a diagnosis of dementia or a Memory Impairment Screen score of less than 5) -insufficient English language skills to fully participate in the program -an inability to leave the house without physical assistance from another person -a progressive neurological disease (e.g., Parkinson’s disease) -a medical condition precluding exercise (e.g., unstable cardiac disease) -or if they already meet the Australian Physical Activity Guidelines for older adults (operationalised as 30 minutes of moderate intensity physical activity 5 days a week assessed using the Incidental and Planned Exercise Questionnaire and they have had a falls risk assessment in the past year and subsequently implemented fall prevention strategies as a result of the risk assessment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Informed consent
Baseline measurement
Central randomisation by an investigator not involved in recruitment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
General linear models will be used to assess the effect of group allocation on the continuously-scored primary (average physical activity counts per minute) and secondary outcome measures (quality of life, fear of falling, mood, mobility disability, community participation), after adjusting for baseline scores. Between-group differences in goal attainment (primary outcome) will be analysed with ordinal regression. The number of falls per person-year will be analysed using negative binomial regression models to estimate the between-group difference in fall rates after one year (secondary outcome). Modified Poisson regression models will be used to compare groups on dichotomous outcome measures (proportion of fallers, proportion meeting physical activity guidelines).

A total of 130 participants (65 per group) will provide 80% power to detect a 15% between-group difference in the primary physical activity outcome (i.e., a between-group difference of 35 mean counts per minute during wear time, standard deviation of 91), a dropout rate of 15% and alpha of 5%. The estimates of mean accelerometer counts per minute for this calculation were taken from the 263 community dwelling USA-based women aged 65 and older in a large sample of accelerometer data. We took a conservative approach and estimated the proportion of dropouts at 15% although our previous trials have had lower dropout rates. These calculations were undertaken in Stata 12 using the sampsi command, assuming a 0.7 correlation between measures and assuming a post-test between-group comparison that adjusted for baseline scores.

A sample size of 130 will also provide 80% power to detect a clinically meaningful 20% between-group difference in goal attainment scores. The sample size will also be sufficient to detect between-group differences in the order of 10-15% for the secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2014
Actual
28/01/2014
Date of last participant enrolment
Anticipated
Actual
13/08/2015
Date of last data collection
Anticipated
Actual
30/08/2016
Sample size
Target
130
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288358 0
Government body
Name [1] 288358 0
Marrickville Council
Country [1] 288358 0
Australia
Funding source category [2] 289708 0
Other
Name [2] 289708 0
Research bequest
Country [2] 289708 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The George Institute for Global Health
PO Box M201 Missenden Rd
NSW 2050
Country
Australia
Secondary sponsor category [1] 287065 0
None
Name [1] 287065 0
Address [1] 287065 0
Country [1] 287065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290239 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 290239 0
University of Sydney HREC.
The University of Sydney. NSW. 2006
Ethics committee country [1] 290239 0
Australia
Date submitted for ethics approval [1] 290239 0
Approval date [1] 290239 0
17/10/2013
Ethics approval number [1] 290239 0
2013/789

Summary
Brief summary
This trial aims to establish the impact of a physical activity and fall prevention intervention compared to an advice brochure on physical activity levels, mobility goal attainment, fall rates, mobility disability, quality of life, fear of falling, mood and community participation in community-dwelling older people.
We hypothesise that at the end of the 12 month follow-up period, intervention participants will be more physically active, have fewer falls and improve on measures of mobility goal attainment, mobility disability, quality of life, fear of falling, mood and community participation compared to control group participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44598 0
A/Prof Anne Tiedemann
Address 44598 0
The George Institute for Global Health, PO Box M201 Missenden Rd, NSW 2050
Country 44598 0
Australia
Phone 44598 0
61280524393
Fax 44598 0
Email 44598 0
atiedemann@georgeinstitute.org.au
Contact person for public queries
Name 44599 0
A/Prof Anne Tiedemann
Address 44599 0
The George Institute for Global Health, PO Box M201 Missenden Rd, NSW 2050
Country 44599 0
Australia
Phone 44599 0
61280524393
Fax 44599 0
Email 44599 0
atiedemann@georgeinstitute.org.au
Contact person for scientific queries
Name 44600 0
A/Prof Anne Tiedemann
Address 44600 0
The George Institute for Global Health, PO Box M201 Missenden Rd, NSW 2050
Country 44600 0
Australia
Phone 44600 0
61280524393
Fax 44600 0
Email 44600 0
atiedemann@georgeinstitute.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA novel approach to the issue of physical inactivity in older age.2015https://dx.doi.org/10.1016/j.pmedr.2015.07.008
EmbaseWhat is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals? Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s12889-015-1380-7
N.B. These documents automatically identified may not have been verified by the study sponsor.