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NCT07825480
Activity Post Spinal Surgery Engagement Trial
Conditions: Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Sex: All
Ages: 40 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Brigham and Women's Hospital
Location: Mass General Brigham Boston Massachusetts
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07825480). StuddyBuddy aggregates publicly available trial information.