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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03729856




Registration number
NCT03729856
Ethics application status
Date submitted
24/10/2018
Date registered
5/11/2018
Date last updated
19/04/2019

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] 0 0
2018000349/2017/743
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whiplash Injuries 0 0
Sedentary Lifestyle 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - intervention
Other interventions - B
Other interventions - Follow-up

Experimental: B5 week,intervention,follow-up - Participants will undertake their usual activities for the 5 week baseline period. Participants will begin the 16 week intervention period at week 6 during which time they will participate in 12 sessions with an accredited exercise physiologist. Beginning week 22, participants will have no contact with intervention personnel during the 5 week follow-up period.

Experimental: B8 week,intervention,follow-up - Participants will undertake their usual activities for the 8 week baseline period. Participants will begin the 16 week intervention period at week 9 during which time they will participate in 12 sessions with an accredited exercise physiologist. Beginning week 25, participants will have no contact with intervention personnel during the 5 week follow-up period.

Experimental: B11 week,intervention,follow-up - Participants will undertake their usual activities for the 11 week baseline period. Participants will begin the 16 week intervention period at week 12 during which time they will participate in 12 sessions with an accredited exercise physiologist. Beginning week 28, participants will have no contact with intervention personnel during the 5 week follow-up period.


Behaviour: intervention
The adapted physical activity (APA) intervention is a theory-based physical activity (PA) promotion intervention. The APA model is comprised of 4 steps: 1) pre-participation evaluation of physiological, personal and environmental factors that influence PA adoption and maintenance; 2) application of individualised, evidence based strategies associated with increased PA participation tailored to the participant's motivational readiness; 3) development of structured exercise and/or lifestyle PA program; and 4) tailored relapse prevention strategies to maintain physical activity beyond the duration of the program. The intervention will be conducted in the participant's home environment.

Other interventions: B
Participants will undertake their usual activities during the baseline period. An extended pre-intervention time frame is needed to establish a stable control phase and enhance internal validity.

Other interventions: Follow-up
Participants will have no contact with intervention personnel during the 5 week follow-up, withdrawal period. The withdrawal phase enables initial assessment of physical activity behavior change.

Intervention code [1] 0 0
Behaviour
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physical activity participation - Habitual physical activity measured by the ActiGraph GT9 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 or epoch, to give a number of "counts." An epoch of 1 minute will be used in this study. 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. Counts will be classified as either moderate-vigorous PA (MVPA) or light/sedentary using the Freedson et al (1998) cut-point. All data collection periods will comprise a 4 day (3 week days and 1 week-end day) PA monitoring period.
Timepoint [1] 0 0
up to 32 weeks
Primary outcome [2] 0 0
Confidence in daily activities - 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] 0 0
up to 32 weeks
Primary outcome [3] 0 0
Pain interference: PROMIS- Pain interference Scale - Three questions of the validated PROMIS- Pain interference Scale (Amtmann et al, 2010) 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.
Timepoint [3] 0 0
up to 32 weeks
Secondary outcome [1] 0 0
Neck disability index - The NDI is a valid, reliable and responsive measure of neck pain related disability (Vernon & Mior, 1991). 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.
Timepoint [1] 0 0
up to 32 weeks
Secondary outcome [2] 0 0
Social support for physical activity - Social support will be measured using the 13-item scale developed by Sallis et al. (1987). 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.
Timepoint [2] 0 0
up to 32 weeks
Secondary outcome [3] 0 0
Decisional Balance for Physical Activity Participation - Decisional balance will be measured using the 16-item scale developed by Marcus et al (1992) which includes 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.
Timepoint [3] 0 0
up to 32 weeks
Secondary outcome [4] 0 0
Health related quality of life - Health related quality of life will be assessed using the Medical Outcomes Survey Short Form (SF-12). The SF-12 contains 12 questions relating to the domains 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) (Cheak-Zamora et al, 2009). Physical and mental component summary scores are computed using the 12 questions and range from 0 (lowest level of health) to 100 (highest level of health).
Timepoint [4] 0 0
up to 32 weeks
Secondary outcome [5] 0 0
Numeric Pain Rating Scale - Participants will be asked to rate their current pain using a Numeric Pain Rating Scale (McCaffery & Beebe, 1989). 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.
Timepoint [5] 0 0
up to 32 weeks
Secondary outcome [6] 0 0
Pain Catastrophizing Scale - 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) (Sullivan et al, 1995).
Timepoint [6] 0 0
up to 32 weeks
Secondary outcome [7] 0 0
Pain Self-Efficacy Questionnaire - 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) (Nicholas, 2007). Responses are totalled to provide a score out of 60 with higher scores reflecting stronger self-efficacy beliefs.
Timepoint [7] 0 0
up to 32 weeks
Secondary outcome [8] 0 0
The Depression, Anxiety and Stress Scale short version (DASS21) - 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 (Parkitny & McAuley, 2010). 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 (Lovibond & Lovibond, 1995). Higher scores on each subscale indicate increased symptom severity.
Timepoint [8] 0 0
up to 32 weeks
Secondary outcome [9] 0 0
Impact of Event Scale-Revised (IES-R) - The 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 (Weiss et al, 1999). 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.
Timepoint [9] 0 0
up to 32 weeks
Secondary outcome [10] 0 0
Physical activity avoidance - Avoidance of PA participation will be assessed using the Avoidance Subscale of the Negative Responsivity to Pain measure (Jensen et al., 2017). Participants will be asked to respond to 4 questions relating to PA avoidance. Responses are made on a 5 point Likert-type scale ranging from 0 indicating I never feel this way to 4 indicating I feel this all the time. The Negative Responsivity to Pain Measure has been shown to have excellent internal consistency and adequate test-retest reliability (Jensen et al., 2017).
Timepoint [10] 0 0
up to 32 weeks
Secondary outcome [11] 0 0
Motivational readiness for change - Motivational readiness for change will be assessed using Marcus' Stage of Change Questionnaire (Marcus et al). 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. Yes is scored as '1' and no as '0' and a total score for the 4 questions is calculated where higher scores indicate more regular participation in physical activity.
Timepoint [11] 0 0
up to 32 weeks

Eligibility
Key inclusion criteria
- Individuals with grade II or III whiplash of at least 3 months duration;

- Individuals living in the Brisbane, Gold Coast or Northern NSW region;

- Individuals with a neck disability index score (NDI) >32% (e.g., indicative of a
moderate disability);

- individuals deemed to be medically safe to participate in moderate intensity PA; and

- individuals currently not participating in structured sport or training for physical
fitness; and not completing 30 minutes or more of moderate physical activity on 5 or
more days per week.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- presence of known or suspected serious spinal pathology;

- confirmed fracture or dislocation at time of injury (e.g., WAD Grade IV);

- nerve root compromise; and

- spinal surgery in the past 12 months.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
QLD
Recruitment hospital [1] 0 0
The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Approximately 50% of adults who have a whiplash injury experience ongoing pain and disability
from whiplash associated disorder (WAD). Causes are multifactorial, with considerable
variation. Studies evaluating interventions for this population have used group-level design
and analysis and, to date, findings have been equivocal and optimal treatment remains a
challenge. In addition to pain and disability, patients are frequently insufficiently active
for good health, increasing their risk of preventable morbidity and mortality, and
compounding the effects of WAD. The proposed study will evaluate an intervention with two
novel features. Firstly, the focus is not directly on the reduction of neck pain and
disability, but aims to evaluate whether evidence-based health promotion/behavior change
strategies can be successfully applied to increase physical activity promotion in this
population. The investigator's hypothesis is that the intervention will not only increase
participation in health enhancing physical activity, but through that engagement, patients
will gain increased confidence to engage in activity in the presence of neck pain, thereby
reducing pain-related disability. Secondly, the Single Case Experimental Design enables
individual level analysis that is not possible with typical group level designs, including
identification of characteristics of responders and non-responders.
Trial website
https://clinicaltrials.gov/show/NCT03729856
Trial related presentations / publications
Kazdin AE. Single-Case Research Designs: Methods for Clinical and Applied Settings, New York: Oxford University Press. 2011.
Kratochwill TR, Hitchcock JH, Horner RH, et al. Single-Case Intervention Research Design Standards. Remedial and Special Education 34: 26-38, 2013.
Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736. Review.
Tate RL, Rosenkoetter U, Wakim D, et al. (2015) The Risk of Bias in N-of-1 Trials (RoBiNT) Scale: An Expanded Manual for the Critical Appraisal of Single-Case Reports., Sydney, Australia.
Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998 May;30(5):777-81.
Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-82. doi: 10.1016/j.pain.2010.04.025.
Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum in: J Manipulative Physiol Ther 1992 Jan;15(1):followi.
Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36.
Marcus BH, Rakowski W, Rossi JS. Assessing motivational readiness and decision making for exercise. Health Psychol. 1992;11(4):257-61.
Cheak-Zamora NC, Wyrwich KW, McBride TD. Reliability and validity of the SF-12v2 in the medical expenditure panel survey. Qual Life Res. 2009 Aug;18(6):727-35. doi: 10.1007/s11136-009-9483-1. Epub 2009 May 8.
McCaffery, M. and A. Beebe, Pain: Clinical Manual for Nursing Practice. 1989, St. Louis, MO: Mosby.
Sullivan, M.J.L., S. Bishop, and J. Pivik, The Pain Catastrophizing Scale: Development and Validation. Psychological Assessment, 1995. 7: p. 524-532.
Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. Epub 2006 Jan 30.
Parkitny L, McAuley J. The Depression Anxiety Stress Scale (DASS). J Physiother. 2010;56(3):204.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43.
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.
Jensen MP, Ward LC, Thorn BE, Ehde DM, Day MA. Measuring the Cognitions, Emotions, and Motivation Associated With Avoidance Behaviors in the Context of Pain: Preliminary Development of the Negative Responsivity to Pain Scales. Clin J Pain. 2017 Apr;33(4):325-334. doi: 10.1097/AJP.0000000000000407.
Public notes

Contacts
Principal investigator
Name 0 0
Carrie Ritchie, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications