Activity Post Spinal Surgery Engagement Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in average daily step count
研究概览
简要总结
Back pain can be disabling, limiting the ability to walk and to engage in physical activity. For patients with degenerative lumbar spinal stenosis, decompressive surgery often provides substantial pain relief and improved mobility. However, research has shown that even after successful surgery, most patients do not increase physical activity or walking. This is important because regular physical activity can help older adults prevent and manage chronic disease, delay functional decline, and maintain independence.
The goal of our study, called the Activity post Spinal Surgery Engagement Trial (ASSET), is to test whether a behavioral program can help patients become more physically active after spine surgery. The investigators have evaluated strategies to help people improve their physical activity after knee replacement surgery and would now like to understand whether these interventions are effective for patients undergoing spine surgery.
The intervention combines two approaches designed to motivate behavior change. Motivational interviewing invokes internal motivation, where patients work with a trained coach to recognize the importance of walking habits, prepare for change, and develop and implement an effective walking plan. External motivation is based on financial incentives, where patients receive small but concrete rewards for obtaining their physical activity goals.
The investigators want to test whether this intervention is better than simply providing patients with an activity tracker, so the study will randomly assign interested participants to one of two groups: the motivational interviewing and financial incentive intervention, or a control arm. All participants will receive a Fitbit activity monitor, and patients in the intervention group will also receive coaching sessions and financial incentives. This pilot study will help determine whether the program is acceptable to patients and whether it shows promise for improving physical activity after spine surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 40-85 years
- •Scheduled to undergo a decompressive lumbar laminectomy with or without concomitant lumbar fusion
- •LSS is principal diagnosis for lumbar decompression surgery
- •Passes the Physical Activity Readiness Questionnaire (PAR-Q)
- •Agrees to all study technology requirements
- •Able to wear the ActiGraph for ≥ 4/7 days for ≥ 10 hours per day during pre-screening
- •Average baseline steps/day < 6,000 during pre-screening assessment period
排除标准
- •Lives in a nursing home
- •Non-English speaking
- •Uses a wheelchair for all ambulation
- •Has a physical condition resulting in inability to walk or makes walking -unstable
- •Diagnosis of dementia, epilepsy, Parkinson's Disease, or peripheral neuropathy with documented gait or balance disturbance of falls related to the condition
- •Has psychological issues that preclude participation
- •Surgeon-documented other reason for study exclusion
- •Primary indication for surgery is not lumbar spinal stenosis (this could include primary or metastatic tumor, spine infection, or sagittal deformity issues)
- •Has an inpatient or musculoskeletal surgery scheduled within the 6 months following lumbar decompression surgery
- •Has a history of past spine surgery within one year of date of pre-screen
- •Has a history of more than one spine surgery in the zone of proposed surgery
研究组 & 干预措施
Wrist-based activity tracker
Participants in this arm receive usual post-operative care, complete all basic study activities, and receive a wrist-based activity tracker intervention.
干预措施: Wrist based activity tracker wear (Behavioral)
Wrist-based activity tracker
Participants in this arm receive usual post-operative care, complete all basic study activities, and receive a wrist-based activity tracker intervention.
干预措施: Basic Study Activities (Other)
Wrist-based activity tracker + TAC(MI)+FI
Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI.
干预措施: Wrist based activity tracker wear (Behavioral)
Wrist-based activity tracker + TAC(MI)+FI
Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI.
干预措施: Basic Study Activities (Other)
Wrist-based activity tracker + TAC(MI)+FI
Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI.
干预措施: Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives (Behavioral)
结局指标
主要结局
Change in average daily step count
时间窗: 2 weeks pre-LDS to 32 Weeks post-LDS
The primary efficacy outcome in this trial is the difference in average daily step count at end of intervention (Week 32) between the two treatment arms as measured by the ActiGraph activity monitor.
Feasibility: Proportion of eligible participants who consent
时间窗: Baseline
The proportion of eligible participants who consent to the study will be computed as the number of participants who consent divided by the number of participants eligible to participate.
Feasibility: Retention rate
时间窗: 52 Weeks post-LDS
Retention rate will be calculated as the number of participants completing the 12-month follow-up divided by the number of participants randomized.
Feasibility: Satisfaction
时间窗: 52 Weeks post-LDS
Satisfaction with the study will be assessed on a 4 point Likert scale from 'very satisfied' to 'very dissatisfied'.
次要结局
- Change in weekly minutes of moderate-to-vigorous physical activity (MVPA)(2 weeks pre-LDS to 32 Weeks post-LDS)
- Change in Oswestry Disability Index (ODI)(2 weeks pre-LDS to 52 Weeks post-LDS)
- Change in 40-meter fast-paced walk test(2 weeks pre-LDS to 32 Weeks post-LDS)
- Change in Mini-BESTest (Mini Balance Evaluation Systems Test)(2 weeks pre-LDS to 32 Weeks post-LDS)
研究者
Jamie Collins
Associate Professor
Brigham and Women's Hospital