Trial registered on ANZCTR


Trial ID
ACTRN12610000805077
Ethics application status
Approved
Date submitted
6/09/2010
Date registered
27/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
RESTORE: Recovery exercises and Stepping On after fracture.
Scientific title
Self-managed home exercise plus group-based discussion compared with usual care to improve physical functioning and prevent falls in older people who have completed rehabilitation for a lower limb or pelvic fracture: a randomised controlled trial
Secondary ID [1] 252360 0
Northern Sydney Central Coast Health (NSCCH)
Local Reference: Protocol 0905-089M
Universal Trial Number (UTN)
Trial acronym
RESTORE

Health condition
Health condition(s) or problem(s) studied:
Lower limb and pelvic fracture in older people 257873 0
Condition category
Condition code
Injuries and Accidents 258033 258033 0 0
Fractures
Physical Medicine / Rehabilitation 258034 258034 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group will receive home visits of 45-60 minutes duration from a physiotherapist. The physiotherapist will prescribe an individualised exercise program and use motivational interviewing and goal setting to encourage behaviour change with regard to exercise. The physiotherapists will conduct ten home visits throughout the 12-month study period and provide fortnightly phone calls. Participants will be encouraged to continue the exercises three times weekly at home. The program will involve the following features: exercise will be individually prescribed based on assessment of physical abilities; there will be an emphasis on functionally-relevant weight-bearing exercise designed primarily to reduce falls and disability by enhancing balance and functional abilities; and exercises will include repetitions of the sit-to-stand movement, semisquats from a standing position, reaching in standing, forward, backward and sideways walking and stepping up onto blocks. The exercise intervention is suitable for people after lower limb or pelvic fracture on the basis of previous work led by Investigators Sherrington, Moseley, Lord and Cameron.

Intervention group participants will also be offered fall prevention education through individualised advice from the physiotherapist or attendance at the group based “Stepping On” program. The Stepping On program was developed by Chief Investigator Clemson as implemented by the NSW Department of Health: weekly 2-hour group discussion sessions for seven weeks. The Stepping On content will be relevant to people with fall-related lower limb or pelvic fracture and will cover coping with visual loss and regular visual screening, medication management, environmental and behavioural home safety, and community safety. Group sessions will be held in rooms at local community centres or hospitals. Transport will be provided for those who would otherwise be unable to attend the sessions. Each program will be attended by up to 13 people. The group sessions will be facilitated by a occupational therapist or other health professional. The group sessions will be completed within the 12-month study period, with the timing depending on availability of a Stepping On program. Individualised fall prevention advice from the study physiotherapists will cover similar topic areas and will provided to participants who are unable or unwilling to attend the Stepping On groups, those for whom no local group is available and those who do not meet eligibility criteria for the NSW health Stepping On programs eg those who use walking aids. The individualised fall prevention advice will be provided at each physiotherapy home visit.
Intervention code [1] 256924 0
Rehabilitation
Comparator / control treatment
Usual care for the duration of one year. Usual care is a
combination of aged care and health services that are
routinely provided. They may include referral to a physiotherapist or falls clinic.
Control group
Active

Outcomes
Primary outcome [1] 258882 0
Mobility-related disability will be assessed with the Short Physical Performance Battery (SPPB) and the computerised version of the Boston University Activity Measure for Post Acute Care (AM-PAC)
Timepoint [1] 258882 0
Baseline and 12 months after randomisation The AM-PAC will also be administered by phone at 3, 6, 9 and 12 months after randomisation.
Primary outcome [2] 258883 0
The life role participation aspect of functioning will be assessed using the Late Life Functioning and Disability Instrument, Disability Component.
Timepoint [2] 258883 0
Baseline and 12 months after randomisation
Primary outcome [3] 258885 0
Rate of falls
Timepoint [3] 258885 0
Assessed as the total number of falls occurring in the 12 months after randomisation as assessed by monthly calendars and phone calls.
Secondary outcome [1] 265235 0
Hospital re-admission rates
Timepoint [1] 265235 0
Monthly via calendars for the first 12 months after randomisation. With data linkage at 2 and 4 years after randomisation
Secondary outcome [2] 265300 0
Falls risk using physiological Profile Assessment
Timepoint [2] 265300 0
Baseline and 12 months after randomisation
Secondary outcome [3] 265301 0
Frailty will be assessed using a continuous scale based on the Fried criteria.
Timepoint [3] 265301 0
Baseline and 12 months after randomisation
Secondary outcome [4] 265302 0
Balance and mobility will be assessed with individual components of the Physiological Profile Assessment (PPA), Short Physical Performance Battery (SBBP) and the Step Test, maximal balance range, co-ordinated stability, choice stepping reaction time.
Timepoint [4] 265302 0
Baseline and 12 months after randomisation
Secondary outcome [5] 265303 0
Nutritional status will be assessed indirectly using Body Mass Index
Timepoint [5] 265303 0
Baseline and 12 months after randomisation
Secondary outcome [6] 265304 0
Physical activity will be assessed using the Incidental and Planned Exercise Questionnaire.
Timepoint [6] 265304 0
Baseline and 12 months after randomisation
Secondary outcome [7] 265305 0
Pain will be assessed on a 7-point scale.
Timepoint [7] 265305 0
Baseline and 12 months after randomisation
Secondary outcome [8] 265306 0
Falls efficacy will be assessed with the short version of the Falls Efficacy Scale-International.
Timepoint [8] 265306 0
Baseline and 12 months after randomisation
Secondary outcome [9] 265307 0
Mood will be assessed using the Geriatric Depression Scale and the Positive and Negative Affect Scale
Timepoint [9] 265307 0
Baseline and 12 months after randomisation
Secondary outcome [10] 265308 0
Quality of life will be assessed using the European Quality of Life-5 dimensions (EQ-5D) and the Short Form 12-item Survey(SF-12).
Timepoint [10] 265308 0
Baseline and 12 months after randomisation. The EQ-5D will also be administered by phone at 3, 6, and 9 months after randomisation
Secondary outcome [11] 319001 0
Questions about self-rated fear of falling and balance. The Questions about self-rated fear of falling and balance were designed by CI Lord and have been used in previous trials. The participant is asked to report how they feel their balance is, using a 5 point scale (excellent, very good, good, fair, poor), and to report how afraid they are of falling, using a 5 point scale (not at all, little bit, moderately, quite a lot, extremely).
Timepoint [11] 319001 0
12 months.
Secondary outcome [12] 319002 0
Physical Activity Stages of Change Questionnaire
Timepoint [12] 319002 0
12 months
Secondary outcome [13] 319003 0
Use of walking aid, assessed via participant self-report of a walking aid a) usually used indoors and b) usually used outdoors.
Timepoint [13] 319003 0
12 months
Secondary outcome [14] 319004 0
Assistance from others with daily tasks. Measured as the number of times the participant has received assistance from any agencies to do each of 7 tasks, and the number of times the participant has received regular assistance from family or friends to do each of the 7 tasks
Timepoint [14] 319004 0
12 months
Secondary outcome [15] 319005 0
Mini Nutritional Assessment
Timepoint [15] 319005 0
12 months
Secondary outcome [16] 319006 0
Health-system and community-service contact. These are assessed via participant self-report on monthly calendars. The participant records all appointments with a GP, medical specialist, allied health, paid agency services. Inpatient hospital and emergency department contact will be assessed using data linkage via the NSW CHeReL.
Timepoint [16] 319006 0
12 month period
Secondary outcome [17] 319007 0
Proportion of fallers. Participants will be asked to record falls on 12 one-month calendars and to return completed calendars in pre-paid envelopes to the research centre each month. If calendars are not returned, participants will be telephoned to ask about their fall history for that month. Any fall reported on the calendars will be followed up with a phone call to obtain further information about the details and consequences of the fall.
Timepoint [17] 319007 0
12 month study period

Eligibility
Key inclusion criteria
People with a fall-related lower limb or pelvic fracture who have completed active physiotherapy and/or rehabilitation and who are living at home or in a hostel
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residing in nursing home, Mini Mental State Examination (MMSE) under 24, insufficient English language skills, inability to walk 10 metres despite assistance from another person or walking aid, a progressive neurological disease e.g. Parkinsons disease and a medical condition precluding exercise e.g. unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aneurysm

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)
The research assistant screens for inclusion criteria. If the person satisfies criteria the research assistant completes baseline assessment then contacts the lead investigator who will determine group allocation. The lead investigator will not be directly involved in participant recruitment. Allocation therefore involves contacting the holder of the allocation schedule who is at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be determined using a computer generated random number schedule with randomly permuted block sizes. The schedule will be developed by the lead investigator who will not be directly involved in participant recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/04/2010
Actual date of first participant enrolment
1/04/2010
Anticipated date last participant enrolled
Actual date last participant enrolled
30/11/2014
Target sample size
350
Actual sample size
336
Recruitment status
Closed: follow-up continuing
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 3115 0
2067
Recruitment postcode(s) [2] 3116 0
2095
Recruitment postcode(s) [3] 3117 0
2217
Recruitment postcode(s) [4] 3118 0
2250

Funding & Sponsors
Funding source category [1] 257376 0
Government body
Name [1] 257376 0
National Health and Medical Research Council
Address [1] 257376 0
GPO Box 1421
Canberra
ACT 2601
Country [1] 257376 0
Australia
Primary sponsor type
Individual
Name
Prof Cathie Sherrington
Address
The George Institute for Global Health,
PO Box M201, Missenden Road, NSW 2050
Country
Australia
Secondary sponsor category [1] 256706 0
None
Name [1] 256706 0
Address [1] 256706 0
Country [1] 256706 0
Other collaborator category [1] 251410 0
Individual
Name [1] 251410 0
Professor Lindy Clemson
Address [1] 251410 0
University of Sydney, Corner City Road and Butlin Avenue, Camperdown, NSW, 2050
Country [1] 251410 0
Australia
Other collaborator category [2] 251411 0
Individual
Name [2] 251411 0
Prof Stephen Lord
Address [2] 251411 0
Neuroscience Research Australia (NeuRA) - Formerly known as the Prince of Wales Medical Research Institute. Barker Street, Randwick, NSW, 2031
Country [2] 251411 0
Australia
Other collaborator category [3] 251412 0
Individual
Name [3] 251412 0
Prof Kirsten Howard
Address [3] 251412 0
University of Sydney, Corner City Road and Butlin Avenue, Camperdown, NSW, 2050.
Country [3] 251412 0
Australia
Other collaborator category [4] 251413 0
Individual
Name [4] 251413 0
Dr Anne Moseley
Address [4] 251413 0
The George Institute for Global Health,
PO Box M201,
Missenden Road, NSW 2050
Country [4] 251413 0
Australia
Other collaborator category [5] 251414 0
Individual
Name [5] 251414 0
Dr Constance Vogler
Address [5] 251414 0
Geriatrician,
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country [5] 251414 0
Australia
Other collaborator category [6] 251415 0
Individual
Name [6] 251415 0
Prof Ian Cameron
Address [6] 251415 0
Royal Rehabilitation Centre Sydney, Rehabilitation Studies
Unit,
PO Box 6 Ryde NSW 1680
Country [6] 251415 0
Australia
Other collaborator category [7] 251416 0
Individual
Name [7] 251416 0
Assoc. Prof Jacqueline Close,
Address [7] 251416 0
Geriatrician
Prince of Wales Hospital, Barker Street, Randwick, NSW 2031
Country [7] 251416 0
Australia
Other collaborator category [8] 251417 0
Individual
Name [8] 251417 0
Prof David Sonnabend
Address [8] 251417 0
Orthopaedic Unit
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country [8] 251417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259394 0
HARBOUR Human Research Ethics Committee (HREC) of Northern Sydney Central Coast Health (NSCCH)
Ethics committee address [1] 259394 0
The Reserach Office, Level 4, Vindin House, Royal North
Shore Hospital, St Leonards NSW 2065
Ethics committee country [1] 259394 0
Australia
Date submitted for ethics approval [1] 259394 0
09/04/2009
Approval date [1] 259394 0
27/05/2009
Ethics approval number [1] 259394 0
HREC/09/HARBR/57

Summary
Brief summary
This National Health and Medical Research Council (NHMRC)funded clinical trial will assess the effect of an exercise-based self-management program for older people who have suffered a lower limb or pelvic fracture in the last two years. The intervention involves a combination of physiotherapy home-visits to establish a home-exercise program and the group-based the Stepping On program. Motivational interviewing and goal setting will be used to encourage behaviour change with regard to exercise and safe community mobility. Three hundred and fifty participants will be recruited from hospitals, health professional practices and general advertising. Primary outcomes are mobility-related disability, community participation and falls. Cost-effectiveness analysis will be undertaken for the primary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31459 0
Prof Cathie Sherrington
Address 31459 0
The George Institute for Global Health
PO Box M201
Missenden Rd NSW 2050
Country 31459 0
Australia
Phone 31459 0
+61 2 9657 0386
Fax 31459 0
Email 31459 0
csherrington@george.org.au
Contact person for public queries
Name 14706 0
Prof Cathie Sherrington
Address 14706 0
The George Institute for Global Health,
PO Box M201,
Missenden Road, NSW 2050
Country 14706 0
Australia
Phone 14706 0
+61 2 9657 0300
Fax 14706 0
+61 2 9657 0301
Email 14706 0
csherrington@georgeinstitute.org.au
Contact person for scientific queries
Name 5634 0
Prof Cathie Sherrington
Address 5634 0
The George Institute for Global Health,
PO Box M201,
Missenden Road, NSW 2050
Country 5634 0
Australia
Phone 5634 0
+61 2 9657 0300
Fax 5634 0
+61 2 9657 0301
Email 5634 0
csherrington@georgeinstitute.org.au