Evaluation of a Novel Intervention to Promote Engagement in Physical Activity for Individuals With Whiplash Associated Disorder: a Multiple-baseline, Single Case Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Physical activity participation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: intervention (Behavioral)
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.
干预措施: B (Other)
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.
干预措施: Follow-up (Other)
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.
干预措施: intervention (Behavioral)
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.
干预措施: B (Other)
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.
干预措施: Follow-up (Other)
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.
干预措施: intervention (Behavioral)
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.
干预措施: B (Other)
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.
干预措施: Follow-up (Other)
结局指标
主要结局
Physical activity participation
时间窗: up to 32 weeks
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.
Confidence in daily activities
时间窗: up to 32 weeks
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.
Pain interference: PROMIS- Pain interference Scale
时间窗: up to 32 weeks
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.
次要结局
- Social support for physical activity(up to 32 weeks)
- Numeric Pain Rating Scale(up to 32 weeks)
- Health related quality of life(up to 32 weeks)
- Impact of Event Scale-Revised (IES-R)(up to 32 weeks)
- The Depression, Anxiety and Stress Scale short version (DASS21)(up to 32 weeks)
- Physical activity avoidance(up to 32 weeks)
- Motivational readiness for change(up to 32 weeks)
- Neck disability index(up to 32 weeks)
- Decisional Balance for Physical Activity Participation(up to 32 weeks)
- Pain Catastrophizing Scale(up to 32 weeks)
- Pain Self-Efficacy Questionnaire(up to 32 weeks)