An interventional study of Wrist based activity tracker wear and Basic Study Activities in Spinal Surgery for Lumbar Spinal Stenosis (LSS), sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 75 is close to the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Compared within Spinal Stenosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm receive usual post-operative care, complete all basic study activities, and receive a wrist-based activity tracker intervention.
Behavioral: Wrist based activity tracker wear · Other: Basic Study Activities
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.
Behavioral: Wrist based activity tracker wear · Other: Basic Study Activities · Behavioral: Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives
Activity 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 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.
As 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.
Feasibility: Proportion of eligible participants who consent
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.
Time frame: Baseline
Change in average daily step count
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.
Time frame: 2 weeks pre-LDS to 32 Weeks post-LDS
Feasibility: Retention rate
Retention rate will be calculated as the number of participants completing the 12-month follow-up divided by the number of participants randomized.
Time frame: 52 Weeks post-LDS
Feasibility: Satisfaction
Satisfaction with the study will be assessed on a 4 point Likert scale from 'very satisfied' to 'very dissatisfied'.
Time frame: 52 Weeks post-LDS
Change in weekly minutes of moderate-to-vigorous physical activity (MVPA)
Change in the number of minutes per week that subjects spent engaged in MVPA from 2-weeks pre-LDS to 32-weeks post-LDS as measured by ActiGraph
Time frame: 2 weeks pre-LDS to 32 Weeks post-LDS
Change in Oswestry Disability Index (ODI)
Change in subjects' pain and functional status using the Oswestry Disability Index (ODI) at 19, 32, and 52-weeks post-LDS as measured by the questionnaire. The Oswestry Disability Index (ODI) is scored as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.
Time frame: 2 weeks pre-LDS to 52 Weeks post-LDS
Change in 40-meter fast-paced walk test
Change in subjects' performance at 32 weeks post-LDS as measured by the 40-meter fast-paced walk test. The outcome of the 40-meter fast-paced walk test is the time in seconds required to complete the 40-meter distance.
Time frame: 2 weeks pre-LDS to 32 Weeks post-LDS
Change in Mini-BESTest (Mini Balance Evaluation Systems Test)
Change in subjects' performance at 32 weeks post-LDS as measured by the Mini-BESTest (Mini Balance Evaluation Systems Test). Total score for the the Mini-BESTest range from 0 to 28. Higher scores indicate better balance performance.
Time frame: 2 weeks pre-LDS to 32 Weeks post-LDS
Change in quality of life
Change in subjects' quality of life at 19, 32, and 52-weeks post-LDS as measured by the EuroQol-5D on the study questionnaire. Participants rate their health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels ranging from no problems to extreme problems. Responses are combined to describe the participant's health state and can be converted to a preference-based health utility index score, with higher scores indicating better health-related quality of life.
Time frame: 2 weeks pre-LDS to 52 Weeks post-LDS
Change in Mental Health Inventory 5-Dimensions (MHI-5)
Change in mental health status (Mental Health Inventory 5-Dimensions (MHI-5)) at 19, 32, and 52-weeks post-LDS as measured by the questionnaire. Total scores range from 0 to 100, with higher scores indicating better mental health.
Time frame: 2 weeks pre-LDS to 52 Weeks post-LDS
Change in PROMIS Short Form Sleep-Related Impairment
Change in sleep status and quality (PROMIS Short Form Sleep-Related Impairment) at 19, 32, and 52-weeks post-LDS as measured by the questionnaire. Responses are converted to standardized T-scores with a mean of 50 and standard deviation of 10 in the reference population. Higher scores indicate greater sleep-related impairment.
Time frame: 2 weeks pre-LDS to 52 Weeks post-LDS
Plan to share: No — Pilot data largely focused on feasibility and acceptability
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Mar 2028, 16 months after the start.
Of 105 non-industry interventional studies with no phase under Spinal Stenosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 16 months is below that.
Counting every sponsor, half of 123 studies reached it within 30 months; a quarter within 12 and three quarters within 50.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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