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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - 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.


BEHAVIORAL: 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
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physical activity participation
Timepoint [1] 0 0
up to 32 weeks
Primary outcome [2] 0 0
Confidence in daily activities
Timepoint [2] 0 0
up to 32 weeks
Primary outcome [3] 0 0
Pain interference: PROMIS- Pain interference Scale
Timepoint [3] 0 0
up to 32 weeks
Secondary outcome [1] 0 0
Neck disability index
Timepoint [1] 0 0
up to 32 weeks
Secondary outcome [2] 0 0
Social support for physical activity
Timepoint [2] 0 0
up to 32 weeks
Secondary outcome [3] 0 0
Decisional Balance for Physical Activity Participation
Timepoint [3] 0 0
up to 32 weeks
Secondary outcome [4] 0 0
Health related quality of life
Timepoint [4] 0 0
up to 32 weeks
Secondary outcome [5] 0 0
Numeric Pain Rating Scale
Timepoint [5] 0 0
up to 32 weeks
Secondary outcome [6] 0 0
Pain Catastrophizing Scale
Timepoint [6] 0 0
up to 32 weeks
Secondary outcome [7] 0 0
Pain Self-Efficacy Questionnaire
Timepoint [7] 0 0
up to 32 weeks
Secondary outcome [8] 0 0
The Depression, Anxiety and Stress Scale short version (DASS21)
Timepoint [8] 0 0
up to 32 weeks
Secondary outcome [9] 0 0
Impact of Event Scale-Revised (IES-R)
Timepoint [9] 0 0
up to 32 weeks
Secondary outcome [10] 0 0
Physical activity avoidance
Timepoint [10] 0 0
up to 32 weeks
Secondary outcome [11] 0 0
Motivational readiness for change
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
Sex
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
7/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/12/2018
Sample size
Target
Accrual to date
Final
6
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/study/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.
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. doi: 10.1097/00005768-199805000-00021.
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.
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. doi: 10.1016/0091-7435(87)90022-3.
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.
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.
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.
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. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
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.
Lovibond, S. and P. Lovibond, Manual for the Depression Anxiety Stress Scales. 1995, Sydney: Psychology Foundation.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03729856