Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001261303
Ethics application status
Approved
Date submitted
24/08/2017
Date registered
30/08/2017
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel intervention to promote engagement in physical activity for individuals with whiplash associated disorder
Scientific title
Evaluation of a novel intervention to promote engagement in physical activity for individuals with whiplash associated disorder: a multiple-baseline, single case experimental study
Secondary ID [1] 292729 0
Nil known
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Chronic Whiplash Associated Disorders 304494 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303831 303831 0 0
Other physical medicine / rehabilitation
Musculoskeletal 303874 303874 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design will require simultaneous commencement of 3 groups of 2 participants who will be randomly allocated to a 5, 8 or 11 week baseline data collection period. All participants will then complete 16 weeks of a physical activity intervention program and 5 weeks of follow-up data collection. The physical activity intervention will comprise 12, one-hour, face to face sessions provided over a 16-week period and conducted in the participant's home environment.
Intervention code [1] 298972 0
Behaviour
Intervention code [2] 298998 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303192 0
Physical Activity (PA) Participation: The primary outcome measure will be habitual PA measured by the ActiGraph GT9X Link accelerometer. The ActiGraph is a triaxial accelerometer that measures vertical acceleration 25 times each second, and these data are integrated over a user defined period, or epoch, to give a number of “counts.” An epoch of 1 minute will be used in this study [1]. ActiGraph counts provide a real-time indication of the intensity of physical activity performed by an individual – the higher the counts, the greater the activity intensity. It is small, unobtrusive, lightweight, non-reactive and because it collects activity data in real time is capable of assessing the pattern and intensity of activity, as well as total accumulated activity. The ActiGraph link is a wrist worn accelerometer which improves client comfort and compliance. The monitor will be programmed to display the time and date only, and therefore, will not provide feedback regarding activity participation. All data collection periods will comprise a 4 day (3 week days and 1 week-end day) PA monitoring period. On completion of the 4-day monitoring period, the accelerometer data will be downloaded, and a customized Visual Basic Excel Macro will be used to determine daily wear time, daily average counts per minute (cpm), and daily time spent in moderate-vigorous PA (MVPA). Counts will be classified as either MVPA or light/sedentary using the Freedson et al [2] cut-point. For a monitoring day to be considered valid and included for analysis, 600 minutes of wear time will be required [3]. Non-wear time is classified as consecutive 0 counts for at least 60 consecutive minutes, allowing for up to 2 consecutive 1-minute epochs with nonzero counts less than or equal to 100 counts. Daily wear time will be calculated by subtracting the estimated non-wear time from the total monitoring time. 1. Trost, S.G., K.L. McIver, and R.R. Pate, Conducting Accelerometer Based Activity Assessments in Field-Based Research. Medicine and Science in Sports and Exercise, 2005. 37: p. s531-s543. 2. Freedson, P.S., E. Melanson, and J. Sirad, Calibration of the Computer Science and Applications, Inc. Accelerometer. Medicine and Science in Sports and Exercise, 1998. 30: p. 777-781. 3. Choi, L., et al., Validation of Accelerometer Wear and Nonwear Time Classification Algorithm. Medicine and Science in Sports and Exercise, 2011. 43(357-364).
Timepoint [1] 303192 0
Primary outcome measures will be collected weekly during the baseline data collection period, fortnightly during the intervention period, and weekly during the follow-up period.
Primary outcome [2] 303193 0
A custom, single-item question to assess self-efficacy for completing daily tasks: "How confident are you in your ability to perform your daily tasks in the presence of your neck pain or disability?" with participants indicating their response on a 1 to 5 Likert scale with 1 indicating not at all confident, 3 indicating moderately confident, and 5 indicating extremely confident.
Timepoint [2] 303193 0
Primary outcome measures will be collected weekly during the baseline data collection period, fortnightly during the intervention period, and weekly during the follow-up period.
Primary outcome [3] 305545 0
Three questions of the validated PROMIS- Pain interference Scale [1] will be used to assess pain interference, a possible consequence of pain on relevant life aspects. These items are as follows: (a) In the past seven days, how much did pain interfere with your day to day activities?, (b) In the past seven days, how much did pain interfere with work around the home?, and (c) In the past seven days, how much did pain interfere with your ability to participate in social activities? Responses are made on a 5 point Likert-type scale with 1 = not at all; 2 = a little bit; 3 = somewhat; 4 = quite a bit; and 5 = very much.
[1} Amtmann, D. et al. Development of a PROMIS item back to measure pain interference. Pain, 2010. 150(1); 173-82.
Timepoint [3] 305545 0
Primary outcome measures will be collected weekly during the baseline data collection period, fortnightly during the intervention period and weekly during the follow-up period.
Secondary outcome [1] 338192 0
Neck Disability Index (NDI): The NDI is a valid, reliable and responsive measure of neck pain related disability [1, 2]. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. An overall score (out of 100) will be calculated by totaling responses to 10 questions, each with 6 potential Likert-type responses (e.g., 0 indicating no disability to 5 indicating total disability), and multiplying the sum by 2 to yield a percentage. 1. MacDermid, J.C., et al., Measurement Properties of the Neck Disability Index: A Systematic Review. Journal of Orthopaedic and Sports Physical Therapy, 2009. 39(5): p. 400-412. 2. Vernon, H. and S. Moir, The Neck Disability Index: A Study of Reliability and Validity. Journal of Manipulative Physiological Therapeutics, 1991. 14(7): p. 409-415.
Timepoint [1] 338192 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [2] 338193 0
Social Support for Physical Activity Participation: Social support will be measured using the 13-item scale developed by Sallis et al. [1]. A 5-point Likert type scale will be used to rate the frequency of support received from family and friends in the 3-months prior, with 1 indicating none, and 5 indicating very often. Social support scores will be calculated for family and friends separately by computing the sum of the items on the measure [39].

1. Sallis, J., et al., The Development of Scales to Measure Social Support for Diet and Exercise Behaviours. Preventative Medicine, 1987. 16: p. 825-836.
Timepoint [2] 338193 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [3] 338194 0
Decisional Balance for Physical Activity Participation: Decisional balance will be measured using the 16-item scale developed by Marcus et al [1] which included 6 items representing the avoidance of exercise (cons) and 10 items representing the positive perceptions of exercise (pros). A 5-point Likert-type scale will be used to rate how important each statement is, with 1 indicating not at all important, and 5 indicating extremely important. The average of the 10 pro items and the 6 con items will be computed. The difference in the averages (i.e., average pro score - average con score) will be taken as the decisional balance score.

1. Marcus, B.H., W. Rakowski, and J.S. Rossi, Assessing Motivational Readiness and Decision Making For Exercise. Health Psychology, 1992. 11: p. 257-261.
Timepoint [3] 338194 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [4] 338195 0
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 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) [1, 2]. The 12 items will be used to calculate a physical and mental component summary score [3]. The SF-12 has demonstrated evidence of validity and reliability for use in individuals with chronic disease including cervical spine disorders [4].

1. Cheak-Zamora, N.C. and K.W. Wyrwich, Reliability and Validity of the SF-12v2 in the Medical Expenditure Panel Survey. Quality of Life Research, 2009. 18(6): p. 727-735.
2. Jakobsson, U. and A. Westergren, Construct Validity of the SF-12 in Three Different Samples. Journal of Evaluation in Clinical Practice, 2012. 18(3): p. 560-566.
3. Ware J, K.M., Keller S. A SF-12: How to Score the SF-12 Physical and Mental Health Summary Scales. Vol. Second Edition. 1995, Boston, MA.: The Health Istitute, New England Medical Center.
4. Lee, C. and D. Jones, Measuring Health of Patients with Cervical Spinal Disorder: Is the SF-12 Health Survey a Valid Alternative for the SF-36. The Journal of Pain, 2007. 8(4): p. s22.
Timepoint [4] 338195 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [5] 338196 0
Numeric Pain Rating Scale: Participants will be asked to rate their current pain using a Numeric Pain Rating Scale [1]. Participants will be asked to select the number that best represents their pain during the previous 24-hours on a scale of 0 to 10; with 0 indicating no pain and 10 indicating worst possible pain. Evidence indicates that Numeric Pain Rating Scales can provide sufficient discriminative power for chronic pain patients to describe their pain intensity [2]. 1. McCaffery, M. and A. Beebe, Pain: Clinical Manual for Nursing Practice. 1989, St. Louis, MO: Mosby. 2. Jensen, M.P., J.A. Turner, and J.M. Romano, What is the Maximum Number of Levels Needed in Pain Intensity Measurement? Pain, 1994. 58: p. 387-392.
Timepoint [5] 338196 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [6] 338197 0
Pain Catastrophizing Scale (PCS): Catastrophizing is defined as “an exaggerated negative mental set brought to bear during an actual or anticipated painful experience” [1]. The PCS is a 13-item instrument that measures the degree to which a participant has experienced specific thoughts or feelings when experiencing pain. Responses are provided on a 5-point scale with 0 indicating not at all and 4 indicating all the time. A total pain catastrophizing score may be calculated in addition to three subscales: rumination, magnification and helplessness. The total sum of responses yields a score out of 52 with higher scores indicating greater pain catastrophizing. A PCS total score >24 indicates a high level of pain catastrophizing. The PCS has been shown to have adequate internal consistency (coefficient alphas: total PCS= .87, rumination= .87, magnification= .66, and helplessness= .78) [2]. 1. Sullivan, M.J.L., et al., Theoretical Perspectives on the Relation Between Catastrophizing and Pain. The Clinical Journal of Pain, 2001. 17: p. 52-64. 2. Sullivan, M.J.L., S. Bishop, and J. Pivik, The Pain Catastrophizing Scale: Development and Validation. Psychological Assessment, 1995. 7: p. 524-532.
Timepoint [6] 338197 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [7] 338198 0
Self-Efficacy Scale: The Pain Self-Efficacy Questionnaire (PSEQ) is a self-administered, 10 item questionnaire survey that was developed to assess an individual’s confidence to perform specific tasks in the presence of pain. Confidence in performing each of 10 activities/tasks despite current pain is rated from 0 (not at all confident) to 6 (completely confident) [1]. Responses are totalled to provide a score out of 60 with higher scores reflecting stronger self-efficacy beliefs.

1. Nicholas, M., The Pain Self-Efficacy Questionnaire: Taking Pain into Account. European Journal of Pain, 2007. 11: p. 153–163.
Timepoint [7] 338198 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [8] 338199 0
Depression and Anxiety: The Depression, Anxiety and Stress Scale short version (DASS21) is a widely used, valid and reliable self-administered tool that is designed to assess symptoms of three negative emotional states: depression, anxiety and stress [1]. The 21-item self-administered survey contains three subscales: depression, anxiety and stress. Each subscale contains 7-items. There are 4 response options for each item with 0 indicating did not apply to me at all, never and 3 indicating applied to me very much or most of the time, almost always. Scores are totalled for each subscale [2]. Higher scores on each subscale indicate increased symptom severity.

1. Parkitny, L. and J. McAuley, The Depression Anxiety Stress Scale (DASS). Journal of Physiotherapy, 2010. 56: p. 204.
2. Lovibond, S. and P. Lovibond, Manual for the Depression Anxiety Stress Scales. 1995, Sydney: Psychology Foundation.
Timepoint [8] 338199 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [9] 338200 0
Posttraumatic Stress Symptoms: The Impact of Event Scale-Revised (IES-R) is a self-administered, 22-item survey developed to assess an individuals’ subjective distress to a specific traumatic event. The IES-R comprises 3 subscales: intrusion, avoidance and hyperarousal [1]. The client is asked to report the degree of distress experienced for each item over the past 7 days. Each question has 5 response options with 0 indicating not at all and 4 indicating extremely. The scores therefore range from 0-4 for each subscale and 0-12 for the total, with higher scores indicating greater distress.

1. Weiss, D., et al., The Impact of Event Scale-Revised, in Assessing Psychological Trauma and PTSD: a Practitioner's Handbook. 1999, Guilford Press: New York. p. 399-411.
Timepoint [9] 338200 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period.
Secondary outcome [10] 338201 0
Process Evaluation: At the conclusion of the intervention participants will be asked to participate in a semi-structured interview regarding their perceptions of the intervention efficacy and acceptability.
Timepoint [10] 338201 0
An interview will be conducted with the participant immediately post intervention.
Secondary outcome [11] 345711 0
Physical activity avoidance: Four questions which comprise the Avoidance Subscale of the Negative Responsivity to Pain measure will be used to assess possible avoidance of physical activity as a result of the whiplash injury, The Negative Responsivity to Pain measure is a validated measure of physical activity avoidance [1]. 1. Jensen, Ward et al. Measuring the cognitions, emotions, and motivation associated with avoidance behaviours in the context of pain. Clin J Pain, 33 (4), 325-344.
Timepoint [11] 345711 0
Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end of the intervention; and at the end of the follow-up period.
Secondary outcome [12] 345712 0
Expectation for participation: A single item question will be used to assess participant expectations for participation in the intervention [1]. The question is: Do you think your participation in this program will help you feel better? with response options of 'yes', 'no' and 'don't know' 1. Ozegovic et al. Does expecting mean achieving? The association between expecting to return to work in whiplash associated disorders: a population-based prospective cohort study. Eur Spine J, 18, 893-899.
Timepoint [12] 345712 0
Completion of this question will occur once, at the start of the initial face to face, intervention session.
Secondary outcome [13] 345713 0
Motivational readiness for change: Stage or change or motivational readiness will be assessed using Marcus' State of Change Questionnaire [1]. This questionnaire is comprised of 4 questions relating to intention to be physically active and current activity levels. Regular physical activity in this measure is defined as 30 minutes of physical activity per day on at least 5 days of the week. Participants answer the following items using a yes or no response: I am currently physically active; I intend to become more physically active in the next 6 months; I currently engage in regular physical activity; I have been regularly physically active for the past 6 months.
Timepoint [13] 345713 0
Stage of change will be measured at the initial face to face session to ensure appropriate inclusion, and as a secondary outcome measure, it will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end of the intervention; and at the end of the follow-up period.

Eligibility
Key inclusion criteria
Participants and Recruitment: Five participants aged 18-60 years will be recruited for this study.

Participants meeting the following inclusion criteria are eligible to participate:
• Grade II whiplash of at least 3 months duration;
• Living in a community setting in the Brisbane, Gold Coast or Northern NSW region;
• A neck disability index score >30% (e.g., indicative of a moderate disability) as per the Neck Disability Index (NDI) Scale [1, 2];
• Deemed medically safe to participate in moderate intensity PA as per Exercise and Sports Science Australia’s Adult Pre-Exercise Screening System [3] and the American College of Sports Medicine Guidelines; and
• Currently not enrolled in structured sport or training for physical fitness; and not completing 30 minutes of moderate PA on 5 or more days per week.

1. MacDermid, J.C., et al., Measurement Properties of the Neck Disability Index: A Systematic Review. Journal of Orthopaedic and Sports Physical Therapy, 2009. 39(5): p. 400-412.
2. Vernon, H. and S. Moir, The Neck Disability Index: A Study of Reliability and Validity. Journal of Manipulative Physiological Therapeutics, 1991. 14(7): p. 409-415.
3. Exercise and Sports Science Australia, Adult Pre-Exercise Screening Tool. 2001: Version 1.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the study includes:
• Known or suspected serious spinal pathology (e.g. metastatic disease of the spine);
• Confirmed fracture or dislocation at time of injury – WAD Grade IV;
• Nerve root compromise – WAD Grade III; and
• Spinal surgery in the past 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no randomisation sequence required.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study will utilise an A1-B+maintenance: a baseline (A1 no intervention); intervention phase (B); and follow up (maintenance).
Baseline: Participants will be randomly allocated to a 5, 8 or 11 week baseline phase where they will be asked to continue with their usual behaviour. The timeline of the baseline phase will vary across the participants in order to allow the intervention start point to be randomised.
Intervention Phase: The baseline phase will be followed by a 16-week intervention period. During the intervention participants will participate in 12, one hour sessions over a 16-week period. The intervention will be delivered by an accredited exercise physiologist with experience in exercise prescription for individuals with a disability and behaviour change strategies associated with increasing PA.
Maintenance (Follow-Up) Phase: The intervention phase will be followed by an 5-week follow-up phase where participants will have no contact with the intervention personnel.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Main outcome measures will be plotted against time and visually examined for: (1) level; (2) trend; (3) variability; (4) immediacy of the effect; (5) overlap; and (6) consistency of data patterns in similar phases. More consistency, separation between phases, and strong patterns suggest a real effect. Once each phase is assessed, results from successive phases are compared to determine if the intervention had an effect by changing the outcome from phase to phase [1].

1. Kratochwill, T.R., et al. Single-case designs technical documentation. . What Works Clearinghouse 2010 [cited 2016 30/8/2016]; Available from: Retrieved from website: http://ies.ed.gov/ncee/wwc/pdf/wwc_scd.pdf.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2018
Actual
7/05/2018
Date of last participant enrolment
Anticipated
30/05/2018
Actual
11/05/2018
Date of last data collection
Anticipated
11/11/2018
Actual
3/12/2018
Sample size
Target
6
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 17093 0
4217 - Gold Coast
Recruitment postcode(s) [2] 22457 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 297367 0
University
Name [1] 297367 0
The University of Queensland
Country [1] 297367 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Recover Injury Research Centre
The University of Queensland
Level 7, Rm 710, Oral Health Centre
288 Herston Rd
Herston
Queensland 4006 Australia
Country
Australia
Secondary sponsor category [1] 296344 0
None
Name [1] 296344 0
n/a
Address [1] 296344 0
n/a
Country [1] 296344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298471 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 298471 0
Ethics committee country [1] 298471 0
Australia
Date submitted for ethics approval [1] 298471 0
18/08/2017
Approval date [1] 298471 0
21/10/2017
Ethics approval number [1] 298471 0
2017/743
Ethics committee name [2] 300160 0
University of Queensland's Human Research Ethics Committee
Ethics committee address [2] 300160 0
Ethics committee country [2] 300160 0
Australia
Date submitted for ethics approval [2] 300160 0
20/02/2018
Approval date [2] 300160 0
06/03/2018
Ethics approval number [2] 300160 0
2018000349/HREC/2017/743

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

Contacts
Principal investigator
Name 77182 0
Dr Kelly Clanchy
Address 77182 0
School of Allied Health Sciences
Clinical Science 1 (G02) Room 1.04
Gold Coast Campus
Griffith University, Southport
Queensland 4222 Australia
Country 77182 0
Australia
Phone 77182 0
+61 7 5552-7006
Fax 77182 0
Email 77182 0
[email protected]
Contact person for public queries
Name 77183 0
Carrie Ritchie
Address 77183 0
RECOVER Injury Research Centre
The University of Queensland
Oral Health Centre
Herston Qld 4006 Australia
Country 77183 0
Australia
Phone 77183 0
+61 7 334 64781
Fax 77183 0
Email 77183 0
[email protected]
Contact person for scientific queries
Name 77184 0
Carrie Ritchie
Address 77184 0
RECOVER Injury Research Centre
The University of Queensland
Oral Health Centre
Herston Qld 4006 Australia
Country 77184 0
Australia
Phone 77184 0
+61 7 334 64781
Fax 77184 0
Email 77184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a pilot/proof of concept study, data will not be uploaded onto open source sites


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 promotion intervention for adults with whiplash associated disorders: a single-case experimental design study.2022https://dx.doi.org/10.1080/09638288.2021.1989062
N.B. These documents automatically identified may not have been verified by the study sponsor.