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Trial registered on ANZCTR


Registration number
ACTRN12617000519358
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
10/04/2017
Date last updated
10/03/2020
Date data sharing statement initially provided
12/03/2019
Date results information initially provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity education in community rehabilitation
Scientific title
Is a brief intervention of physical activity education and counselling feasible to deliver in the Community Rehabilitation setting?
Secondary ID [1] 288564 0
Nil known
Universal Trial Number (UTN)
U1111-1179-7975
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 297686 0
stroke 297688 0
falls 297689 0
Condition category
Condition code
Injuries and Accidents 297865 297865 0 0
Fractures
Stroke 297866 297866 0 0
Ischaemic
Physical Medicine / Rehabilitation 297867 297867 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive one additional session to their usual therapy regimen, for the provision of physical activity education and counselling. This will be a 15-45minute session, based in the Community Rehabilitation Centre and conducted by the research co-ordinator or a Grade 2 Community Rehabilitation Physiotherapist.
The education element will focus on the health benefits of cardiovascular exercise. The counselling will be targeted to the participant's stage-of-change in relation to exercise, as assessed by the Exercise Stage of Change Assessment. The therapist delivering the intervention will match advice to stage of change in accordance with the guidelines outlined in:
Jordan PJ & Nigg CR. 2002. Applying the transtheoretical Model: Tailoring interventions to stages of change. Chapter 6. Promoting exercise and behavior change in older adults: Interventions with the Transtheoretical model. Burbank PM & Riebe D.
The intervention will be aimed at increasing long term physical activity levels.

Those in the intervention group will also be provided with one of the two booklets of written educational material to match their age:
<65 years: Department of Health. 2014. Make your move- Sit less- Be active for life! Australian Government or
65 years+: Department of Veterans’ Affairs & Department of Health & Ageing. 2005. Choose Health: Be Active- A physical activity guide for older Australians. Australian Government.

They will also be provided with a personalised written walking program. Advice regarding duration and frequency of daily walks will be based on the participant's current and previous levels of physical activity, as discussed during the interview, The aim will be to gradually grade up a walking program to assist the participant to meet the Physical Activity guidelines of 30minutes of moderate intensity exercise, at least 5 times per week.
Intervention code [1] 293949 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care from their treating therapists with the addition of provision of a government physical activity educational handout matched to their age:

Department of Health. 2014. Make your move- Sit less- Be active for life! Australian Government or
Department of Veterans’ Affairs & Department of Health & Ageing. 2005. Choose Health: Be Active- A physical activity guide for older Australians. Australian Government
Control group
Active

Outcomes
Primary outcome [1] 297393 0
Feasibility of the intervention in this population, including; number of eligible participants, number of participants recruited to the trial, number of participants receiving the intervention and number of participants followed up at 3 months.
Timepoint [1] 297393 0
3 month follow up from the delivery of the intervention
Secondary outcome [1] 320956 0
Daily physical activity levels as measured by GENEActiv activity monitor,
GENEActiv is a waterproof activity monitor to be worn by participants on their wrist for a period of seven days. Data collected from the activity monitor will include; sedentary time and time spent in very light, light, moderate and vigorous physical activity (composite data).
Timepoint [1] 320956 0
This outcome will be measured at baseline (at discharge from community rehabilitation) and at three months following the intervention.
Secondary outcome [2] 320957 0
Quality of life will be measured on the Assessment of Quality of Life (AQOL) 6D questionnaire. This tool encompasses the domains of independent living, mental health, coping, relationships, pain and senses. This self-reported measure is valid and reliable for use in the community rehabilitation population.
Timepoint [2] 320957 0
This outcome will be measured at baseline and at 3 months following the intervention.
Secondary outcome [3] 320958 0
Stage-of-change in relation to exercise will be measured on the Exercise Stage Assessment questionnaire. This scale asks participants to rate their intention to engage in regular exercise by selecting one of five statements which best reflects their current intention or behaviour related to participating in regular exercise.
Timepoint [3] 320958 0
This outcome will be assessed at baseline and at three months following the intervention.
Secondary outcome [4] 320959 0
Self-efficacy will be measured using the Self- Efficacy for Exercise (SEE) Scale. The SEE asks participants to rate their confidence to exercise under 11 different conditions on a 10 point scale. The SEE has been validated for use in older adults.
Timepoint [4] 320959 0
This outcome will be assessed at baseline and at three months following the intervention.

Eligibility
Key inclusion criteria
Participants attending Alfred Health Community Rehabilitation Program Centre-based services located in Caulfield and South Melbourne.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants excluded from the study will include non-ambulant participants, those with medical or safety issues preventing them from safely participating in regular physical activity and those who have cognitive impairment (Mini Mental State Exam score less than 24 or diagnosis of Dementia) or insufficient command of English, preventing them from understanding the educational material and consent form.

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)
Allocation will be concealed using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken using a computer generated sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Randomisation will occur after completion of the baseline assessment.
Randomisation will be stratified by age (18 to 64 years vs 65 years and over).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
As this is a feasibility study, this research project will not be powered to detect differences in physical activity levels, quality of life, stage of change or self-efficacy for exercise.
The feasibility data will be reported descriptively, The secondary outcomes such as, difference in physical activity levels, quality of life scores, stage of change level and self-efficacy towards exercise will be compared between groups using repeated measures ANOVA, linear mixed models or chi squared test as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5292 0
Caulfield Hospital - Caulfield
Recruitment postcode(s) [1] 12759 0
3162 - Caulfield

Funding & Sponsors
Funding source category [1] 292912 0
Hospital
Name [1] 292912 0
Caulfield Hospital Small Research Project Grant
Address [1] 292912 0
260 Kooyong Rd
Caulfield VIC 3162
Country [1] 292912 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Office of ethics and research governance
Alfred Hospital
55 Commercial Rd
Prahran VIC 3004
Country
Australia
Secondary sponsor category [1] 291668 0
University
Name [1] 291668 0
La Trobe University
Address [1] 291668 0
Graduate Research School
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora VIC 3086
Country [1] 291668 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294420 0
Alfred Health
Ethics committee address [1] 294420 0
Office of ethics and research governance
Alfred Hospital
55 Commercial Rd
Prahran VIC 3004
Ethics committee country [1] 294420 0
Australia
Date submitted for ethics approval [1] 294420 0
25/02/2016
Approval date [1] 294420 0
05/04/2016
Ethics approval number [1] 294420 0
117/16
Ethics committee name [2] 294421 0
La Trobe University
Ethics committee address [2] 294421 0
Graduate research school
Plenty Rd and Kingsbury Drive
Bundoora VIC 3086
Ethics committee country [2] 294421 0
Australia
Date submitted for ethics approval [2] 294421 0
11/04/2016
Approval date [2] 294421 0
Ethics approval number [2] 294421 0

Summary
Brief summary
Clients attend Alfred Health Community Rehabilitation Program for goal-oriented rehabilitation following a change in their health status (i.e. stroke, joint replacement, falls). Many of these clients are elderly and/or suffer from one or more chronic health conditions (i.e. osteoarthritis, diabetes, heart disease).
Rehabilitation is targeted to address current goals and concerns, however no formal education is given about the benefit of adherence to a long-term physical activity program.
This study will assess the feasibility of delivering a single session intervention of physical activity education and counselling, geared towards encouraging long-term physical activity. The intervention will be delivered at the end of the client’s community rehabilitation program encounter.
On completion of baseline measures, clients will be allocated to either the intervention or usual care group. Usual care group clients will receive standard care with the addition of being provided with written physical activity educational material.
The intervention group will receive one additional session to their usual therapy regimen, for the provision of physical activity education and counselling. They will also be provided with written educational material and a personalised written walking program. The intervention will be tailored to the participant's stage of change and self efficacy in relation to exercise. These items will be assessed using questionnaires, completed both at baseline and at three-month follow up.
The primary outcome will be assessing the feasibility of this intervention, considering the rate of recruitment, completion of the intervention, and follow up rates.
Physical activity levels will be assessed using an activity monitor at baseline and three-month follow-up. Participants will need to wear the activity monitor armband for one week at each assessment point. This will collect data about energy expenditure, sedentary time and time spent in moderate and vigorous physical activity. Quality of Life will also be assessed, using a questionnaire.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 63626 0
Dr Anne Holland
Address 63626 0
Level 4, The Alfred Centre, 99 Commercial Rd Melbourne VIC 3004
Country 63626 0
Australia
Phone 63626 0
+61 3 9479 6744
Fax 63626 0
+61 3 9533 2104
Email 63626 0
A.Holland@latrobe.edu.au
Contact person for public queries
Name 63627 0
Mrs Emily Green
Address 63627 0
Alfred Health Community Rehabilitation Program
260 Kooyong Rd, Caulfield VIC 3162
Country 63627 0
Australia
Phone 63627 0
+61 3 9076 6232
Fax 63627 0
+61 3 9076 6209
Email 63627 0
e.green2@alfred.org.au
Contact person for scientific queries
Name 63628 0
Mrs Emily Green
Address 63628 0
Alfred Health Community Rehabilitation Program
260 Kooyong Rd, Caulfield VIC 3162
Country 63628 0
Australia
Phone 63628 0
+61 3 9076 6232
Fax 63628 0
+61 3 9076 6209
Email 63628 0
e.green2@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7302 0
Study protocol
Citation [1] 7302 0
Link [1] 7302 0
Email [1] 7302 0
e.green2@alfred.org.au
Other [1] 7302 0
Attachment [1] 7302 0
Type [2] 7303 0
Informed consent form
Citation [2] 7303 0
Link [2] 7303 0
Email [2] 7303 0
e.green2@alfred.org.au
Other [2] 7303 0
Attachment [2] 7303 0
Type [3] 7304 0
Ethical approval
Citation [3] 7304 0
Link [3] 7304 0
Email [3] 7304 0
e.green2@alfred.org.au
Other [3] 7304 0
Attachment [3] 7304 0
Type [4] 7305 0
Statistical analysis plan
Citation [4] 7305 0
Link [4] 7305 0
Email [4] 7305 0
e.green2@alfred.org.au
Other [4] 7305 0
Attachment [4] 7305 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary