Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000864022
Ethics application status
Approved
Date submitted
5/10/2010
Date registered
15/10/2010
Date last updated
4/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Lifestyles Program for Adults with an Acquired Brain Injury.
Scientific title
A Randomised Clinical Trial of a Community Based Intervention for the Promotion of Physical Activity Among Community Dwelling People with an Acquired Brain Injury.
Secondary ID [1] 252781 0
n/a
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 258281 0
Traumatic Brain Injury 258282 0
Stroke 258283 0
Condition category
Condition code
Neurological 258479 258479 0 0
Other neurological disorders
Public Health 258519 258519 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention aims to promote physical activity in adults with an acquired brain injury. Primarily, this intervention utilises a range of individually tailored, evidence based strategies that aim to transition individuals through the first three stages of change – pre-contemplation, contemplation and preparation (Prochaska & Velicer, 1997). One of the principal strategies used will be motivational interviewing, which focuses on enhancing the intrinsic motivation of the individual for change by exploring and resolving ambivalence, in order to promote natural change (Emmons & Rollnick, 2001). This process will be facilitated by influencing factors related to behaviour change including the; knowledge underlying the behaviour; value of the behaviour; perceived costs and benefits of the behaviour; barriers to change and beliefs regarding the participant’s ability to perform the behaviour (Bundy, 2004).

Motivational interviewing has four basic principles; expressing empathy, supporting self-efficacy, rolling with resistance and developing discrepancy (Bundy, 2004). These principles are used to facilitate a “shared understanding” between the participant and investigator regarding physical activity and are used to help the participant:
- Understand his or her thought processes related to increased physical activity;
- Understand the values of the participant relating to increased physical activity;
- Identify how their thoughts and feelings interact to produce their current activity levels;
- Develop cognitive dissonance to challenge their thought patterns and discuss the implementation of alternative behaviours.

By discussing the participants thoughts and feelings regarding increasing their physical activity, the investigator aims to evoke “change talk”—expressions of the participants desire, ability, reasons, and need for change (Hettema, Steele, & Miller, 2005).

The motivational interviewing philosophy, approach, and methods are uniquely suited to assist individuals to transition through the first three stages of change (DiClemente & Velasquez, 2002). Through using this technique the participant is in charge of their decision to change, the selection of their own goals and the processes by which they are achieved.

In addition to motivational interviewing, the intervention uses other evidence based strategies in order to facilitate and support change. The selection of these strategies is determined by the stage of change (i.e. precontemplation, contemplation and preparation) that the participant is determined to be in based on the stage of change algorithm. These strategies include; goal setting, social support, use of the leisure diagnostic battery and physical activity monitoring.

Participants will have 9 face to face sessions with an Exercise Physiologist over a 3 month period. Each session will last approximately 1 hour and will be facilitated in the participants home. The frequency of the sessions will be dictated by the participants time constraints. The selection of the evidence based strategies will be undertaken based on the participants goals and barriers to facilitating behaviour change. These evidence based strategies will be included in the one hour session and will also be facilitated by the exercise physiologist.
Intervention code [1] 257297 0
Lifestyle
Intervention code [2] 257298 0
Behaviour
Intervention code [3] 257299 0
Prevention
Comparator / control treatment
The control intervention for this study will comprise of a series of discussions regarding oral health, sun safety and sleep. These behaviours were chosen due to their particular importance for adults and because they are not likely to lead to increased participation in physical activity. The participants will take part in a series of activities including information sessions, evaluation of current health promotional materials and questionnaires to evaluate their current behaviour and diaries to monitor their future behaviour. These activities will be undertaken not to criticise the adolescent’s current behaviour or attempt to gain a commitment to behaviour change, but to:
1) discuss the participant’s thoughts and feelings regarding the behaviour;
2) discuss the perceived importance of these behaviours for adults with an acquired brain injury;
3) Discuss their current engagement in the health behaviour;
4) Investigate and discuss goals and strategies for increasing their engagement in the health behaviour.

Participants will have 9 face to face sessions with an Exercise Physiologist over a 3 month period. Each session will last approximately 1 hour and will be facilitated in the participants home. The frequency of the sessions will be dictated by the participants time constraints.
Control group
Active

Outcomes
Primary outcome [1] 259310 0
Physical Activity: Physical activity will be measured using an ActiGraph (GT3X). The ActiGraph is a triaxial accelerometer that measures vertical acceleration 10 times each second, and these data are integrated over a user defined period, or epoch, to give a number of 'counts' which is written to the memory at the end of each epoch. ActiGraph counts provide a real-time index of the amount of physical activity performed by an individual; the higher the counts, the greater the activity level.

Raw ActiGraph data will be analysed in order to provide the following information:
Total counts :
- For the entire monitoring period
- Average per week days monitored
- Average per weekend days monitored
Total time spent in moderate to vigorous activity (MPVA):
- For the entire monitoring period
- Average per week day monitored
- Average per weekend day monitored
Total time spent sedentary:
- For the entire monitoring period
- Average per week day monitored
- Average per weekend day monitored

Minute-by-minute activity counts will be uploaded to a data reduction program written by the investigators of the study in order to determine the amount of time spent sedentary (< 100 counts/min) and in light (101- 1963 counts/min) and moderate (> 1964 counts/min) intensity physical activity during each 60 minute segment of the 7 day monitoring period. Daily totals of the physical activity variables will be calculated by summing the values from the 24, 60 minute blocks comprising each day. Totals for the weekdays will be calculated by summing the values from the five weekdays. Totals for the weekend days will be calculated by summing the values from the two weekend days.
Timepoint [1] 259310 0
Baseline
Immediately Post Intervention
3 Months Post Intervention
Secondary outcome [1] 265741 0
Self-Efficacy: This study will use a five-item self-efficacy scale designed to measure the confidence of the participant in the following areas; negative effect, resistance relapse and making time for exercise. These areas have been shown to be important correlates to physical activity self efficacy.

A five-point scale is used to rate each item on the scale, with one indicating "not at all confident" and five "very confident." An overall self-efficacy score will be calculated by computing the average of all five items on the scale. A higher score on this measure indicates great self efficacy.
Timepoint [1] 265741 0
Baseline
Immediately Post Intervention
3 Months Post Intervention
Secondary outcome [2] 265742 0
Social Support: Social support is determined to be a strong mediator of behaviour change. The concept of social support can be further divided into different components including; instrumental support, informational support, emotional support and appraising support. The instrument used to measure social support in this study will identify the level and source of support received by the participant in the three months prior.

A six-point scale will be used to rate the frequency of social support from family and friends that the participants receives, with zero indicating "does not apply to me" one indicating "none" and five indicating "very often." The sum of the items for family support and friend support will be calculated individually. Higher scores reflect more perceived social support.
Timepoint [2] 265742 0
Baseline
Immediately Post Intervention
3 Months Post Intervention
Secondary outcome [3] 265743 0
Stage of Change: Stage of change of the participants will be assessed using an algorithm (Marcus, Selby, et al., 1992). The algorithm asks participants to select the response that best describes their current activity levels. Regular exercise is defined as participating in three or more activity sessions per week for twenty minutes or more at each time.
Timepoint [3] 265743 0
Baseline
Immediately Post Intervention
3 Months Post Intervention
Secondary outcome [4] 265744 0
Decisional Balance: Decisional balance is the ratio of perceived benefits to barriers of change. In regards to physical activity, decisional balance refers to a person's perception of the benefits of physical activity compared to its negative effects (Marcus, Rakowski, & Rossi, 1992). The scale used to measure decisional balance in this study is comprised of six items representing the avoidance of exercise (cons) and ten-item components representing the positive perceptions of exercise (pros). Statements were determined based on decisional categories including a) gains or losses expected for oneself, b) gains or losses expected for significant others, c) self-approval or disapproval due to the behaviour and d) approval or disapproval by other due to the behaviour. Participants are asked to rate on a likert scale of one to five how important each statement is with one indicating "not at all important" and five indicating "extremely important."

The average of the ten pro items and the six con items will be computed. The difference in the averages (i.e., pros-cons) is the decisional balance score. Decisional balance scores greater than zero show that the participant sees more barriers than benefits of physical activity. The larger the negative score, the more barriers the participant sees relative to the benefits.
Timepoint [4] 265744 0
Baseline
Immediately Post Intervention
3 Months Post Intervention
Secondary outcome [5] 265745 0
Health Related Quality of Life: Participant's health related quality of life will be assessed using The Medical Outcomes Survey Short Form (SF-12) measure. The SF-12 is a shortened version of the SF-36 Health Survey. The SF-12 contains 12 questions relating to domains including: physical functioning; role limitations because of physical health problems; bodily pain; general health perceptions; vitality (energy/fatigue); social functioning; role limitations because of emotional problems; and general mental health (psychological distress and psychological well-being). The twelve items are used to calculate a physical and mental component summary score, by applying a scoring algorithm empirically derived from the data of a United States general population survey.
Timepoint [5] 265745 0
Baseline
Immediately Post Intervention
3 Months Post Intervention
Secondary outcome [6] 265746 0
Intervention Effectiveness: Participants and their significant other/family member will complete a semi-structured interview with the aim of evaluating their perceptions of the effectiveness and acceptability of the interventions and methods of assessment. The perceptions of the participant and their significant other/family member will be collected separately post intervention in a face to face interview. In each interview a series of open ended questions will be asked in order to gain an understanding of the acceptability, burden and effectiveness of the intervention. Where necessary a series of planned and unplanned prompts will be used in order to gain more detailed information. Responses to each question will be flagged as positive and negative and communicated in the results of this intervention.
Timepoint [6] 265746 0
Immediately Post Intervention

Eligibility
Key inclusion criteria
Individuals participating in this study will be included on the basis of the following selection criteria; diagnosis of an acquired brain injury (ABI); more than one year post discharge from a hospital; 18-50 years of age; living in a community setting within a 100km radius of the University of Queensland; walking as their primary means of locomotion (with or without aids) (Hoffer Functional Ambulation Scale 1 and 2); medically stable (confirmed through the Physical Activity Readiness Questionnaire (PAR-Q) and a medical history questionnaire conforming with the standards recommended by the American College of Sports Medicine); stage of change 1-3 (self reported) and having the cognitive ability to follow simple verbal or written instructions commensurate with a physical activity program.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study on the basis of the following criteria; lower limb surgery 6 months prior; lower limb botox 3 months prior; serious, regular or uncontrolled substance abuse; excessively violent of aggressive behaviour and serious suicidal ideation.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Forty community dwelling adults with an acquired brain injury will be recruited for this study. Participants will be offered the opportunity of enrolling in a study which aims to promote physical activity, oral health, sun safety and sleep in adults with an acquired brain injury. Participants will be recruited through the Acquired Brain Injury Outreach Service (Princess Alexandra Hospital), Open Minds, the Brain Injury Rehabilitation Unit (Princess Alexandra Hospital), Endeavour Foundation (Queensland) and the Brain Injury Association of Queensland. Rehabilitation coordinators from these organisations will screen for eligible participants and will provide these participants with the materials for the study. These participants will be asked to contact the investigator of the study if interested in participating.

Once participants contact the investigators of the study they will have their stage of change, community ambulation and physical activity levels assessed. Participants who are ineligible for the study will be provided with information regarding the benefits and opportunities for increasing their physical activity, sun safety, oral health and sleep in their community. Participants who are deemed eligible for the study will be provided with an information statement and consent form. Once the participant consents to being in the study they will undergo a baseline data collection and randomisation to the healthy behaviour and physical activity intervention.

The baseline data collection will be undertaken by the principle investigator of the study. The allocation of the participant to the intervention or control group will be done by a person independent of the study by flipping a coin. The first participant to be assigned to a given cell will be randomly allocated to the intervention or control group by flipping a coin, and the next person recruited into that cell will be assigned to the control group or the intervention group depending on where the first person recruited was allocated – if the first person in a cell was allocated to the intervention group the next person allocated to the same cell will be assigned to the control group; if the first person in a cell was assigned to the control group, the next person allocated to the same cell would be assigned to the intervention group. The randomisation will be undertaken after the baseline data collection period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be enrolled in the study as they are recruited. Once enrolled, participants will be assigned to one of four cells based on their stage of change and Hoffer stage.

Having been assigned to a cell, participants will be allocated to either the control or intervention group according to the following procedure: the first participant to be assigned to a given cell will be randomly allocated to the intervention or control group by flipping a coin, and the next person recruited into that cell will be assigned to the control group or the intervention group depending on where the first person recruited was allocated – if the first person in a cell was allocated to the intervention group the next person allocated to the same cell will be assigned to the control group; if the first person in a cell was assigned to the control group, the next person allocated to the same cell would be assigned to the intervention group. This process of alternately allocating randomly and then purposefully will be followed until all participants have been allocated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2010
Actual
1/11/2010
Date of last participant enrolment
Anticipated
17/12/2012
Actual
17/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 3293 0
North- from 4000 to 4560
Recruitment postcode(s) [2] 3294 0
South- from 4000 to 4280
Recruitment postcode(s) [3] 3295 0
East- from 4000 to 4157
Recruitment postcode(s) [4] 3296 0
West- from 4000 to 4305

Funding & Sponsors
Funding source category [1] 257735 0
Self funded/Unfunded
Name [1] 257735 0
Investigators PhD Fund
Country [1] 257735 0
Australia
Primary sponsor type
Individual
Name
Kelly Clanchy
Address
C/- School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 256949 0
None
Name [1] 256949 0
Address [1] 256949 0
Country [1] 256949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259788 0
School of Human Movement Studies Ethics Committee
Ethics committee address [1] 259788 0
Ethics committee country [1] 259788 0
Australia
Date submitted for ethics approval [1] 259788 0
29/09/2010
Approval date [1] 259788 0
04/10/2010
Ethics approval number [1] 259788 0
HMS10/0410

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

Contacts
Principal investigator
Name 31712 0
Dr Kelly Clanchy
Address 31712 0
C/- School of Science and Technology
The University of New England
Armidale NSW 2350
Country 31712 0
Australia
Phone 31712 0
+61267733083
Fax 31712 0
Email 31712 0
[email protected]
Contact person for public queries
Name 14959 0
Kelly Clanchy
Address 14959 0
C/- School of Science and Technology
The University of New England
Armidale NSW 2350
Country 14959 0
Australia
Phone 14959 0
+61267733083
Fax 14959 0
Email 14959 0
[email protected]
Contact person for scientific queries
Name 5887 0
Kelly Clanchy
Address 5887 0
C/- School of Science and Technology
The University of New England
Armidale NSW 2350
Country 5887 0
Australia
Phone 5887 0
+61267733083
Fax 5887 0
Email 5887 0
[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
SourceTitleYear of PublicationDOI
EmbaseEvaluation of a Physical Activity Intervention for Adults with Brain Impairment: A Controlled Clinical Trial.2016https://dx.doi.org/10.1177/1545968316632059
N.B. These documents automatically identified may not have been verified by the study sponsor.