Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000380099
Ethics application status
Approved
Date submitted
7/12/2009
Date registered
11/05/2010
Date last updated
11/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Easy Steps to Health: The effectiveness of walking in reducing falls in older people
Scientific title
A randomised controlled trial investigating the effect of walking on falls risk in older people.
Secondary ID [1] 1543 0
nil
Universal Trial Number (UTN)
U1111-1112-3979
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 252124 0
Injury Prevention 252188 0
Condition category
Condition code
Injuries and Accidents 252331 252331 0 0
Other injuries and accidents
Public Health 252386 252386 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one year (48 weeks), progressive, self-managed, home-based walking programme delivered by mail and supported by telephone calls (both occcurring at baseline, weeks 4, 12 and 24). The intervention comprises of four stages each with a specific focus. The first two stages will be delivered by post at baseline. Stage one will run for 4 weeks and will focus on getting intervention participants to increase the amount of time they walk (duration). Telephone support will occur at the midpoint between each stage - for stage one this will be at 2 weeks. Stage two will run for 8 weeks and will have an additional focus on increasing the frequency of walks that intervention participants take. Telephone support will occur at week 8. The third stage will be delivered by post at 12-weeks into the study. Stage three will run for 12 weeks and will have an additional focus on increasing the pace of walking (intensity). Telephone support will occur at week 18. The fourth and final stage will be delivered by post at 24-weeks into the study. Stage four will run for 24 weeks and will have focus on sustaining the walking routine developed over the previous three stages. Telephone support will occur at weekn 36. The content of each mail-out will include a walking manual relating to the participant’s stage within the intervention. In addition the initial mail-out will also include a pedometer which will help maintain participants’ motivation to walk, and a falls calendar on which participants will be asked to record any falls they have. The walking manual will include detailed instructions on how to plan a walking schedule related to the focus for the stage of the intervention. Information will also include advice on walking in a safe way and on how to make walking a part of daily activities. At the start of each new stage intervention participants will receive telephone support that will assist participants with developing their personal walking plan and to help motivate participants to stick to their plan. Follow-up telephone support will occur at the mid-point of each stage and will review participants progress through the walking plan, help develop strategies to overcome any barriers or difficulties in progressing through the walking plan and to help keep motivation levels high.
Intervention code [1] 241505 0
Prevention
Intervention code [2] 241544 0
Lifestyle
Intervention code [3] 288442 0
Behaviour
Comparator / control treatment
The control group will receive health education information that is unrelated to reducing the risk of falling. The Health information will be delivered by post according to the same time-frame as for the intervention group participants, i.e. at baseline, 12-weeks and 24 weeks. Control participants will receive information on mental health wellbeing, good sleeping habits and healthy eating. Control group participants will also receive the walking program at the end of the study, i.e. after 48 weeks of enrollment in the study
Control group
Active

Outcomes
Primary outcome [1] 253202 0
Number of falls (Calendar method)
Timepoint [1] 253202 0
Compare groups at 48 weeks
Primary outcome [2] 253203 0
Quality of Life (AQoL - II)
Timepoint [2] 253203 0
Compare groups at 48 weeks
Primary outcome [3] 253204 0
Physical performance assessment (for sub-sample only). Assessment includes: i) choice step reaction time test - lower limb reaction time; ii) quadriceps strength; iii) Short Physical Performance Battery (Lower limb function)
Timepoint [3] 253204 0
Baseline and week 12, 24, and 48
Secondary outcome [1] 262132 0
Confidence in avoiding a fall using the international version of the Falls Efficacy Scale (FES-I)
Timepoint [1] 262132 0
Compare groups at 48 weeks
Secondary outcome [2] 262244 0
Physical Activity levels using accelerometer data (sub-sample only)
Timepoint [2] 262244 0
Baseline and weeks 12, 24, and 48
Secondary outcome [3] 287945 0
Walking self-efficacy, assessed using two scales. The first scale measures behavioural self-efficacy. The second scale assesses self-efficacy in regards to barriers.
Timepoint [3] 287945 0
Compare groups at 48-weeks

Eligibility
Key inclusion criteria
- 65 years and over
- living in the community
- Ability to read and verbally communicating in English
-
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- More than 3 occasions of physical activity per week and a total of more than 120 minutes of physical activity per week
- Inablity to walk unaided for 50 meters
- Any medical conditions limiting ability to participate in walking program
- Currently enrolled in another study
- People with Dementia

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised permuted blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A subsample of 194 participants will have their performance on a range of physical tasks assessed.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2009
Actual
12/10/2009
Date of last participant enrolment
Anticipated
26/11/2010
Actual
30/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
484
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244051 0
Government body
Name [1] 244051 0
NSW Health Promotion Demonstration Research Grants Scheme
Country [1] 244051 0
Australia
Primary sponsor type
Individual
Name
Alexander Voukelatos, Health Promotion Service, Sydney and SouthWest Sydney Local Health Districts
Address
Level 9 (North),
Missenden Road,
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 251398 0
Individual
Name [1] 251398 0
Dafna Merom, School of Biomedical and Health Sciences, University of Western Sydney.
Address [1] 251398 0
School of Biomedical and Health Sciences, University of Western Sydney, Campbletown campus,
Locked Bag 1797, Penrith NSW 2751, Australia
Country [1] 251398 0
Australia
Secondary sponsor category [2] 251441 0
Individual
Name [2] 251441 0
Cathie Sherrington, The George Institute for Global Health
Address [2] 251441 0
PO Box M201
Missenden Rd
Camperdown NSW 2050
Country [2] 251441 0
Australia
Secondary sponsor category [3] 251442 0
Individual
Name [3] 251442 0
Wendy Watson, 5. Transport and Road Safety (TARS) Research, Department of Aviation, University of NSW
Address [3] 251442 0
L1 Old Main Building, University of New South Wales, Sydney, NSW 2052
Country [3] 251442 0
Australia
Secondary sponsor category [4] 251443 0
Individual
Name [4] 251443 0
Chris Rissel, School of Public Health, University of Sydney
Address [4] 251443 0
Level 2, Medical Foundation Building, K25, The University of Sydney, NSW, 2006
Country [4] 251443 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258145 0
Sydney Local Health Distirct Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 258145 0
Research Development Office, Royal Prince Alfred Hospital, Missenden Road, CAMPERDOWN NSW 2050
Ethics committee country [1] 258145 0
Australia
Date submitted for ethics approval [1] 258145 0
24/09/2008
Approval date [1] 258145 0
24/11/2008
Ethics approval number [1] 258145 0
HREC/08/RPAH/477

Summary
Brief summary
A majority of the falls prevention interventions shown to effectively reduce the risk of falling in community dwelling older people, such as Tai Chi, or programs such as ‘Stepping On’ and the ‘Otago exercise program’, involve specialised training or instruction. This specialised activity places limits on the accessibility of such interventions: due to a lack of qualified instructors, the costs involved in joining programs, or the barriers inherent in attending physical activity classes. Only a small proportion of older people benefit from these interventions.

In contrast, walking is a simple activity that can be done by virtually anyone, any time and anywhere without the need for specialised training or equipment. However to date only two studies have examined the effect of walking on falls; one study as a secondary outcome measure the other study combined walking with a home-based exercise program. No studies have explicitly looked at the impact of walking of falls in older people.

The Easy Steps to Health study is a randomised controlled trial investigating the effectiveness of a self-managed one year (48-week) walking program in reducing the number of falls in sedentary, community-dwelling people aged 65 years and over. People will be excluded if: they are already physically active (i.e. engage in physical activity for more than 120 minutes per week or on more than three occasions per week); they cannot communicate in English, and; they have any conditions that limit their ability to participate in a physical activity program.

A total of 484 participants will be randomised into either the intervention or control group. Participants randomised into the intervention group will receive instruction in the walking program via mail and telephone coaching at week 0, 12, and 24 with additional telephone support at weeks 2, 8, 18 and 36. The control group will receive the self-managed walking program at the end of the study period. During the study period the control group will receive healthy lifestyle information.

Falls during the study will be recorded prospectively using a daily calendar. Baseline and end-of-study telephone interviews will be conducted using structured questionnaires assessing ‘Quality of Life’, levels of Physical Activity, confidence in avoiding a fall, confidence in ability to walk, and the ‘walkability’ of their neighbourhood. Baseline interviews will also gather basic demographic information, falls history, and a brief description of current medical conditions and medications being used.

In addition, a sub-sample of 194 participants will receive physical performance assessments. These assessments will gather data on lower limb functionality (using the Short Physical Performance Battery), quadriceps strength and lower limb reaction time (using choice step reaction time). Accelerometers will also be used as a more objective measure of participants’ levels of physical activity. These measures on a sub-sample of participants will occur at weeks 0 (baseline), 12, 24, and 48.
Trial website
Trial related presentations / publications
- 'Easy Steps to Health: A randomised controlled trial investigating the effect of a home-based walking program for preventing falls in older people.' Poster presented at 9th National Injury Prevention Conference, Melbourne, June 2009
Public notes

Contacts
Principal investigator
Name 30464 0
Dr Alexander Voukelatos
Address 30464 0
Health Promotion Service,
Sydney and SouthWest Sydney Local Health Districts,
Level 9 (North),
Missenden Road,
Camperdown, NSW, 2050
Country 30464 0
Australia
Phone 30464 0
+61 02 9515 9079
Fax 30464 0
Email 30464 0
AVOUK@email.cs.nsw.gov.au
Contact person for public queries
Name 13711 0
Dr Alexander Voukelatos
Address 13711 0
Health Promotion Service,
Sydney and SouthWest Sydney Local Health Districts
Level 9 (North), Missenden Road,
Camperdown NSW 2050
Country 13711 0
Australia
Phone 13711 0
+61 2 9515 9079
Fax 13711 0
+61 2 9515 9056
Email 13711 0
AVOUK@email.nsw.gov.au
Contact person for scientific queries
Name 4639 0
Dr Alexander Voukelatos
Address 4639 0
Health Promotion Service,
Sydney and SouthWest Sydney Local Health Districts
Level 9 (North), Missenden Road,
Camperdown NSW 2050
Country 4639 0
Australia
Phone 4639 0
+61 2 9515 9079
Fax 4639 0
+61 2 9515 9056
Email 4639 0
AVOUK@email.nsw.gov.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
EmbaseNeighborhood walkability, fear and risk of falling and response to walking promotion: The Easy Steps to Health 12-month randomized controlled trial.2015https://dx.doi.org/10.1016/j.pmedr.2015.08.011
EmbaseThe impact of a home-based walking programme on falls in older people: The easy steps randomised controlled trial.2015https://dx.doi.org/10.1093/ageing/afu186
EmbaseThe effect of walking on falls in older people: the 'Easy Steps to Health' randomized controlled trial study protocol.2011https://dx.doi.org/10.1186/1471-2458-11-888
N.B. These documents automatically identified may not have been verified by the study sponsor.