A Novel Intervention to Promote Engagement in Physical Activity for Individuals With Whiplash Associated Disorder
Condition: Whiplash Injuries; Sedentary Lifestyle
MeSH terms: Whiplash Injuries
Study type: Interventional

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.
    

Detailed description: 
      Six participants will be recruited in two groups of three participants. Each group will
      comprise three participants who receive the same 16-week intervention (B) and 5-week follow
      up (maintenance), but have different lengths of the baseline period (A). The participants
      will be randomly allocated to one of the two groups, then subsequently randomly allocated to
      a baseline of either 5, 8 or 11 weeks. All participants will begin the baseline phase during
      the same week. Concurrent enrolment will minimize environmental influences and enhance
      internal validity (Kazdin, 2011). Experimental control is demonstrated by using the staggered
      multiple-baseline design across the participants, which controls for threats to internal
      validity (e.g., history, maturation) (Kazdin, 2011). The added feature of randomisation
      strengthens the scientific rigor of the study (Kratochwill and Levin, 2010). The design also
      allows for three demonstrations of the experimental effect (i.e., increased PA following the
      introduction of the intervention, but not before), and replication in a second group of
      participants (Kazdin, 2011).

      During the baseline data collection period (A) participants will be encouraged to undertake
      their usual behaviour. Target behaviour measures (eg primary outcome measures) will be
      collected weekly during the baseline phase. Individual variability is addressed by repeated
      measurement of the target behaviour, and specifically, five data collection points within
      each phase is recommended to effectively evaluate a SCED intervention (Kratochwill et al.,
      2013).

      The 16-week intervention period (B) comprises 12 one-hour intervention sessions (described
      below). An Accredited Exercise Physiologist (AEP) with experience in exercise prescription
      for individuals with a disability and behaviour change strategies associated with increasing
      PA will deliver the intervention. During the intervention period, the target behaviour
      measures will be collected fortnightly.

      The intervention phase will be followed by a 5-week follow up phase where participants will
      have no contact with the AEP and target behaviour measures will be collected weekly. The
      maintenance component allows the target behavior to be monitored after the completion of the
      intervention, with the expectation that the target behavior will not revert to baseline
      levels after the intervention completion (Tate et al., 2015).

      Generalisation measures (eg secondary outcome measures) will be collected at the commencement
      and finish of the baseline data collection period (which coincides with the intervention
      start point), at the end of the intervention period (which coincides with the commencement of
      the maintenance period), and at the end of the maintenance period; totalling 4 sampling
      points throughout the study duration.
    

Intervention name(s): intervention; B; Follow-up
Intervention type(s): Behavioral; Other; Other
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): baseline
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A Single Case Experimental Design (SCED) will be used to evaluate the intervention. Participants act as their own controls, and thus are exposed to both the treatment and control conditions. The study will be conducted and reported according to the Singe Case Reporting guidelines in BEhavioural Interventions (SCRIBE). A randomised, concurrent, multiple-baseline A1 (baseline control) - B (intervention)-A2 (follow-up withdrawal) design will be used to meet the methodological recommendations for SCEDs. Participants will be randomly allocated to a 5, 8 or 11 week baseline period during which they will undertake their usual activities. The baseline phase will be followed by a 16-week intervention period during which participants will participate in 12, one hour sessions with an accredited exercise physiologist. The intervention phase will be followed by a 5-week follow-up phase where participants will have no contact with the intervention personnel.
Masking: None (Open Label)
Primary purpose: Treatment