Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12618000903280
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
29/05/2018
Date last updated
27/05/2020
Date data sharing statement initially provided
10/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of prescribing a walking program to improve physical functioning of people living in the community after hip fracture.
Scientific title
The feasibility of prescribing a walking program to improve physical functioning of people living in the community after hip fracture: A phase II randomised controlled trial
Secondary ID [1] 294923 0
nil known
Universal Trial Number (UTN)
nil known
Trial acronym
nil known
Linked study record
nil known

Health condition
Health condition(s) or problem(s) studied:
hip fracture 307886 0
Condition category
Condition code
Injuries and Accidents 306935 306935 0 0
Fractures
Physical Medicine / Rehabilitation 307084 307084 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to usual care, participants in the intervention group will be prescribed 100 minutes of walking per week, of at least moderate intensity, in bouts of at least 10 minutes. Moderate level of intensity will be determined by the Rate of Perceived Exertion Scale (0 to 10) where level 3 - “I am still comfortable but am breathing a little harder”. The weekly composition of the 100 minutes of walking will be decided in consultation between the participant and the allied health clinician at the planning session (e.g. 5 x 20 min, 6 x 15 min + 1 x 10 min). The walking doses will be completed in the community using normal assistive devices, such as a walking stick if required. The weekly dose will be completed for 12 weeks in the community.
To increase adherence to the intervention and maximise the effectiveness of the intervention, we will use the following behavioural change techniques and strategies:
- Planning session with goal setting – an allied health clinician will assist the participant to determine when and where to complete the dose of walking;
- Supervision - allied health clinician supervision of one session of walking weekly;
- Monitoring - each participant will wear a pedometer provided by the study to self-monitor the number of steps each week when completing their prescribed walking. The allied health clinician will also monitor pain levels at each supervised session using a visual analogue scale. They will also complete a logbook to record the number of steps and time spent walking each week;
- Engaging social supports - each participant will be encouraged to walk with a friend, family member, or other support person.
Intervention code [1] 301237 0
Treatment: Other
Intervention code [2] 301238 0
Rehabilitation
Comparator / control treatment
Participants allocated to usual care may continue with existing exercise programs and access other services, such as having consultations with their community physiotherapist to practice activities of daily living, providing these do not include additional prescription of physical activity. Usual care is based on the usual practice of clinicians providing care in the Community Rehabilitation Program.All participants allocated to the usual care group will receive a copy of the Eastern Health information sheet: “Staying Safe and Steady at Home”. The content of usual care will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 305918 0
Feasibility: Domains of Demand, Acceptability, Implementation, Practicality, and Limited Efficacy testing

Demand domain will be evaluated by analysing the recruitment rate (comparing the number of people recruited to the number of potentially eligible participants), and documenting the reasons for non-participation.

Acceptability domain will be evaluated by completing semi-structured in depth interviews with participants to compare the satisfaction of the intervention group to the control group.
Implementation will be evaluated by recording fidelity of the walking intervention. Fidelity will be evaluated as:
- the proportion of weeks in which intervention participants successfully completed the prescribed dose of walking,
- average minutes of moderate intensity walking completed per week,
- recording walking cadence during supervised sessions and
- by completion of a rating of perceived exertion scale after each session

Practicality domain will be evaluated by recording the number of adverse events and hospital readmissions. Adverse events for each week will be recorded in a log book at each supervised session as serious or non-serious, and whether they are related or not related to the intervention. Participants will be asked to maintain a daily falls calendar for the 12 weeks of the trial. Hospital readmissions will be accessed from health service records as the number of overnight stays in hospital at Eastern Health during the 12-week trial period. In addition reasons for any missed sessions or inability to complete sessions related to issues of tolerability will be recorded in the logbook. Practicality data will be supplemented by analysis of the semi-structured interviews.

Limited Efficacy Testing domain will evaluate functional independence:
The Functional Independence Measure (FIM) will be administered by a credentialed assessor. The FIM consists of 18 items in two domains: motor (13 items) and cognitive (5 items). Each item is rated on a 7 point scale, where 1 reflects complete dependence and 7 reflects complete independence to complete daily tasks. Scores range from 18 (lowest function) to 126 (highest function for the FIM and from 13 (lowest function) to 91 (highest function) for the FIMmotor subscale. A change of 22 points on the FIM and a change of 17 points on the FIMmotor subscale is regarded as clinically significant.



Timepoint [1] 305918 0
Baseline and 12 weeks post intervention
Secondary outcome [1] 347027 0
Functional Autonomy Measurement System (SMAF). The SMAF is a 29-item scale measuring functional ability in 5 areas: Activities of daily living, mobility, communication, mental functions and instrumental activities of daily living.
Timepoint [1] 347027 0
Baseline and 12 weeks post intervention
Secondary outcome [2] 347368 0
The de Morton Mobility Index (DEMMI): a unidimensional measure of mobility. The DEMMI is administered by clinician observation of 15 hierarchical items, with a score range from 0 to 100 with 100 indicative of high levels of independent mobility.
Timepoint [2] 347368 0
Baseline and 12 weeks post intervention
Secondary outcome [3] 347369 0
Modified Falls Efficacy Scale, which measures confidence related to completing physical activity during daily living tasks without falling
Timepoint [3] 347369 0
Baseline and 12 weeks post intervention
Secondary outcome [4] 347370 0
Ambulatory Self-Confidence Questionnaire, which measures confidence related to walking in different situations
Timepoint [4] 347370 0
Baseline and 12 weeks post intervention
Secondary outcome [5] 347372 0
The composite outcome of physical activity will be measured objectively with an accelerometer-based activity monitor (ActivPAL3) expressed as:
-daily time spent walking
-daily number of steps
-daily minutes of moderate and vigorous physical activity
-daily time spent sitting or lying
Timepoint [5] 347372 0
Baseline and 12 weeks post intervention
Secondary outcome [6] 347373 0
Health-related quality of life: Assessment of Quality of Life Instrument (AQoL) 8-D
Timepoint [6] 347373 0
Baseline and 12 weeks post intervention

Eligibility
Key inclusion criteria
Participants will be included if they:
• had a hip fracture (S72.0–S72.2 according to the International Classification of Diseases
10th revision, ICD-10) which was managed surgically,
• are aged 60 years or older,
• are community-dwelling and receiving services from the Community Rehabilitation Program at Eastern Health
• are able to walk independently with or without a gait aid,
• can communicate with conversational English.

Participants will not be excluded on the basis of cognitive impairment. However, if the potential participant scores more than four errors on the 10-item Short Portable Mental Status Questionnaire (indicating more than mild intellectual impairment) then informed consent will be sought from a carer or responsible person. In this case the researcher will explain to the participant, as far as possible, what the research is about and what participation involves.

Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
• have been discharged to live in residential care,
• exceed the physical activity guidelines of at least 150 minutes of moderate to vigorous physical activity

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)
Participants will be randomly assigned using sealed opaque envelopes prepared by an independent researcher with no role in recruitment or assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned using a permuted block design created by a computer random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
At 12 weeks, semi-structured interviews will be completed with participants allocated to the intervention. Thematic analysis of the interviews will allow for exploration of the Feasibility domains of Acceptability and Practicality.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 42 participants will be recruited for this phase II feasibility trial. This sample size is considered sufficient to evaluate feasibility domains of demand, acceptability, implementation, and practicability. For limited efficacy testing a sample size of n=42 would be sufficient detect a large effect of 0.9 at power of 0.8 and alpha level of 0.05. However, for this type of intervention it is not expected likely that a large effect of 0.9 favouring the intervention group will be found. However, a sample size of n=42 will enable estimates of the standardised mean difference to inform design of a phase III trial.
Feasibility data will be analysed through thematic analysis of the semi-structured interviews (Acceptability, Practicality), collection of service level data and analysis of logbooks (Demand, Implementation and Practicality). For Limited Efficacy Testing, linear mixed models will be used to compare the groups in longitudinal data analysis for all continuous outcomes. A negative binomial regression model will be used to analyse readmission and falls data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/06/2018
Actual
2/07/2018
Date of last participant enrolment
Anticipated
30/06/2019
Actual
4/09/2019
Date of last data collection
Anticipated
30/09/2019
Actual
3/01/2020
Sample size
Target
42
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10996 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [2] 10997 0
Wantirna Health - Wantirna
Recruitment hospital [3] 10998 0
Peter James Centre - Forest Hill
Recruitment hospital [4] 10999 0
Yarra Ranges Health - Lilydale
Recruitment postcode(s) [1] 22682 0
3156 - Ferntree Gully
Recruitment postcode(s) [2] 22683 0
3140 - Lilydale
Recruitment postcode(s) [3] 22685 0
3152 - Wantirna
Recruitment postcode(s) [4] 22788 0
3131 - Forest Hill

Funding & Sponsors
Funding source category [1] 299505 0
Hospital
Name [1] 299505 0
Eastern Health
Country [1] 299505 0
Australia
Funding source category [2] 299581 0
University
Name [2] 299581 0
La Trobe University
Country [2] 299581 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
Level 2, 5 Arnold St
Box Hill, Victoria 3128
Country
Australia
Secondary sponsor category [1] 298807 0
University
Name [1] 298807 0
La Trobe University
Address [1] 298807 0
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country [1] 298807 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300406 0
Eastern Health Human research Ethics Committee
Ethics committee address [1] 300406 0
Ethics committee country [1] 300406 0
Australia
Date submitted for ethics approval [1] 300406 0
02/04/2018
Approval date [1] 300406 0
18/05/2018
Ethics approval number [1] 300406 0
E01-2018

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

Contacts
Principal investigator
Name 83562 0
Prof Nicholas Taylor
Address 83562 0
Eastern Health - La Trobe University
Allied Health Clinical Research Office
Level 2, 5 Arnold St
Box Hill, Victoria 3128
Country 83562 0
Australia
Phone 83562 0
+61 3 9091 8874
Fax 83562 0
Email 83562 0
[email protected]
Contact person for public queries
Name 83563 0
Anne Thompson
Address 83563 0
Eastern Health
Allied Health Clinical Research Office
Level 2, 5 Arnold St
Box Hill, Victoria 3128
Country 83563 0
Australia
Phone 83563 0
+61 3 9091 8880
Fax 83563 0
Email 83563 0
[email protected]
Contact person for scientific queries
Name 83564 0
Nicholas Taylor
Address 83564 0
Eastern Health - La Trobe University
Allied Health Clinical Research Office
Level 2, 5 Arnold St
Box Hill, Victoria 3128
Country 83564 0
Australia
Phone 83564 0
+61 3 9091 8874
Fax 83564 0
Email 83564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual data underlying published results only
When will data be available (start and end dates)?
Immediately following publication. No end date determined.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Supplementary data file with open access publication


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.