A Novel Intervention to Promote Engagement in Physical Activity for Individuals With Whiplash Associated Disorder

NCT03729856 | Completed

• 1 other identifier: 2018000349/2017/743
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Injuries; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 32 weeks

• 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.

  up to 32 weeks

• 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.

  up to 32 weeks

Secondary Outcomes (11)

• Neck disability index

  up to 32 weeks

• Social support for physical activity

  up to 32 weeks

• Decisional Balance for Physical Activity Participation

  up to 32 weeks

• Health related quality of life

  up to 32 weeks

• Numeric Pain Rating Scale

  up to 32 weeks

Study Arms (3)

B5 week,intervention,follow-up

EXPERIMENTAL

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.

Behavioral: intervention; Other: B; Other: Follow-up

B8 week,intervention,follow-up

EXPERIMENTAL

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.

Behavioral: intervention; Other: B; Other: Follow-up

B11 week,intervention,follow-up

EXPERIMENTAL

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.

Behavioral: intervention; Other: B; Other: Follow-up

Interventions

intervention BEHAVIORAL

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.

B11 week,intervention,follow-up; B5 week,intervention,follow-up; B8 week,intervention,follow-up

B OTHER

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.

Also known as: baseline

B11 week,intervention,follow-up; B5 week,intervention,follow-up; B8 week,intervention,follow-up

Follow-up OTHER

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.

B11 week,intervention,follow-up; B5 week,intervention,follow-up; B8 week,intervention,follow-up

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

The University of Queensland

Brisbane, Queensland, 4072, Australia

Location

Related Publications (17)

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  BACKGROUND

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MeSH Terms

Conditions

Whiplash Injuries; Sedentary Behavior

Interventions

Methods; BaseLine dental cement

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Carrie Ritchie, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 5, 2018
• Study Start: May 7, 2018
• Primary Completion: December 3, 2018
• Study Completion: December 10, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

AU (1)