ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

nil

Universal Trial Number (UTN)

U1111-1112-3979

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Falls

Injury Prevention

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Public Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Number of falls (Calendar method)

Timepoint [1]

Compare groups at 48 weeks

Primary outcome [2]

Quality of Life (AQoL - II)

Timepoint [2]

Compare groups at 48 weeks

Primary outcome [3]

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]

Baseline and week 12, 24, and 48

Secondary outcome [1]

Confidence in avoiding a fall using the international version of the Falls Efficacy Scale (FES-I)

Timepoint [1]

Compare groups at 48 weeks

Secondary outcome [2]

Physical Activity levels using accelerometer data (sub-sample only)

Timepoint [2]

Baseline and weeks 12, 24, and 48

Secondary outcome [3]

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]

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]

Government body

Name [1]

NSW Health Promotion Demonstration Research Grants Scheme

Address [1]

Strategic Research and Development Branch, Centre for Health Advancement, NSW Health Locked Mail Bag 961 NORTH SYDNEY NSW 2059

Country [1]

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]

Individual

Name [1]

Dafna Merom, School of Biomedical and Health Sciences, University of Western Sydney.

Address [1]

School of Biomedical and Health Sciences, University of Western Sydney, Campbletown campus,
Locked Bag 1797, Penrith NSW 2751, Australia

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Cathie Sherrington, The George Institute for Global Health

Address [2]

PO Box M201
Missenden Rd
Camperdown NSW 2050

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Wendy Watson, 5. Transport and Road Safety (TARS) Research, Department of Aviation, University of NSW

Address [3]

L1 Old Main Building, University of New South Wales, Sydney, NSW 2052

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Chris Rissel, School of Public Health, University of Sydney

Address [4]

Level 2, Medical Foundation Building, K25, The University of Sydney, NSW, 2006

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health Distirct Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Research Development Office, Royal Prince Alfred Hospital, Missenden Road, CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/09/2008

Approval date [1]

24/11/2008

Ethics approval number [1]

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

Dr Alexander Voukelatos

Address

Health Promotion Service,
Sydney and SouthWest Sydney Local Health Districts,
Level 9 (North),
Missenden Road,
Camperdown, NSW, 2050

Country

Australia

Phone

+61 02 9515 9079

Fax

[email protected]

Contact person for public queries

Name

Alexander Voukelatos

Address

Health Promotion Service,
Sydney and SouthWest Sydney Local Health Districts
Level 9 (North), Missenden Road,
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9515 9079

Fax

+61 2 9515 9056

[email protected]

Contact person for scientific queries

Name

Alexander Voukelatos

Address

Health Promotion Service,
Sydney and SouthWest Sydney Local Health Districts
Level 9 (North), Missenden Road,
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9515 9079

Fax

+61 2 9515 9056

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	The effect of walking on falls in older people: the 'Easy Steps to Health' randomized controlled trial study protocol.	2011	https://dx.doi.org/10.1186/1471-2458-11-888
Embase	Neighborhood walkability, fear and risk of falling and response to walking promotion: The Easy Steps to Health 12-month randomized controlled trial.	2015	https://dx.doi.org/10.1016/j.pmedr.2015.08.011
Embase	The impact of a home-based walking programme on falls in older people: The easy steps randomised controlled trial.	2015	https://dx.doi.org/10.1093/ageing/afu186

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically