Activity Post Spinal Surgery Engagement Trial
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT07825480
- Status
- Not Yet Recruiting
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Conditions
- Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Wrist based activity tracker wear — BEHAVIORALActivity tracking data will be collected on a weekly basis. Participants who receive this intervention are eligible to receive $5 for every week they wear their wrist-based activity tracker \>10 hours for \>4/7 days a week, beginning 6-weeks after surgery from weeks 6-31 ($130 maximum total).
- Basic Study Activities — OTHERBasic study activities begin approximately two-weeks before LDS and end approximately 24-months after LDS. Basic study activities include: two in-person visits at the clinic site (2 weeks before LDS and 32-weeks after LDS), having check-in calls with study staff weekly from weeks 1-13 after surgery and every other week for weeks 14-31, completing 4 surveys, and wearing an ActiGraph activity tracker (waist-worn) for three one-week periods throughout the study (2-weeks before-LDS, 32-weeks post-LDS, and one-year post-LDS). All participants will be eligible to receive up to $155 for completing these activities over the course of one year.
- Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives — BEHAVIORALAs part of TAC(MI)+FI, participants speak with a health coach at Brigham and Women's Hospital once a week via telephone for weeks 6-13 following surgery, and once every other week for weeks 14-31 after surgery. Participants in this arm can receive financial rewards for achieving weekly step goals, as well as bonus rewards for achieving goals multiple weeks in a row. Over the course of this 6-month long TAC(MI)+FI intervention period, these participants are able to receive up to $380 for meeting step goals, and up to $110 in bonus rewards for sustaining step goals.
Study Details
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.
Key Dates
- First listed
- Sep 17, 2026
- Start date
- Sep 8, 2026
- Status verified
- Sep 2026
- Primary completion
- Mar 1, 2028
- Completion
- Sep 1, 2028
Study Design
- Enrollment
- 75 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Wrist-based activity trackerParticipants in this arm receive usual post-operative care, complete all basic study activities, and receive a wrist-based activity tracker intervention.
- Experimental: Wrist-based activity tracker + TAC(MI)+FIParticipants 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.
Primary Outcome Measure
Feasibility: Proportion of eligible participants who consent [ Time Frame: Baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mass General Brigham | Boston | Massachusetts | 02139 |