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

NCT ID: NCT03729856

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2018-12-10

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.

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.

Conditions

Whiplash Injuries; Sedentary Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

intervention

Intervention Type: 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.

B

Intervention Type: 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.

Follow-up

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

intervention

Intervention Type: 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.

B

Intervention Type: 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.

Follow-up

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

intervention

Intervention Type: 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.

B

Intervention Type: 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.

Follow-up

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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 Type: OTHER

Other Intervention Names

baseline

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carrie Ritchie, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

The University of Queensland

Brisbane, Queensland, Australia

Countries

Australia

References

Kazdin AE. Single-Case Research Designs: Methods for Clinical and Applied Settings, New York: Oxford University Press. 2011.

Reference Type: BACKGROUND

Kratochwill TR, Hitchcock JH, Horner RH, et al. Single-Case Intervention Research Design Standards. Remedial and Special Education 34: 26-38, 2013.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 20515235 (View on PubMed)

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.

Reference Type: BACKGROUND

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. doi: 10.1097/00005768-199805000-00021.

Reference Type: BACKGROUND

PMID: 9588623 (View on PubMed)

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):173-182. doi: 10.1016/j.pain.2010.04.025.

Reference Type: BACKGROUND

PMID: 20554116 (View on PubMed)

Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

Reference Type: BACKGROUND

PMID: 1834753 (View on PubMed)

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. doi: 10.1016/0091-7435(87)90022-3.

Reference Type: BACKGROUND

PMID: 3432232 (View on PubMed)

Marcus BH, Rakowski W, Rossi JS. Assessing motivational readiness and decision making for exercise. Health Psychol. 1992;11(4):257-61. doi: 10.1037//0278-6133.11.4.257.

Reference Type: BACKGROUND

PMID: 1396494 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19424821 (View on PubMed)

Pain: clinical manual for nursing practice Pain: clinical manual for nursing practice Margo McCaffery Alexander Beebe Mosby Yearbook UK pound17.25 0 7234 1992 2. Nurs Stand. 1994 Dec 7;9(11):55. doi: 10.7748/ns.9.11.55.s69.

Reference Type: BACKGROUND

PMID: 27527475 (View on PubMed)

Sullivan, M.J.L., S. Bishop, and J. Pivik, The Pain Catastrophizing Scale: Development and Validation. Psychological Assessment, 1995. 7: p. 524-532.

Reference Type: BACKGROUND

Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.

Reference Type: BACKGROUND

PMID: 16446108 (View on PubMed)

Parkitny L, McAuley J. The Depression Anxiety Stress Scale (DASS). J Physiother. 2010;56(3):204. doi: 10.1016/s1836-9553(10)70030-8. No abstract available.

Reference Type: BACKGROUND

PMID: 20795931 (View on PubMed)

Lovibond, S. and P. Lovibond, Manual for the Depression Anxiety Stress Scales. 1995, Sydney: Psychology Foundation.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 27428549 (View on PubMed)

Other Identifiers

2018000349/2017/743

Identifier Type: -

Identifier Source: org_study_id