[R01] Physical Activity intervention to improve Surgical Spine outcomes (PASS)
Ente: National Center for Complementary and Integrative Health
Scadenza: 2031-07-31
Importo max: 891.026 EUR
Paese: US
Descrizione
Project Abstract
Degenerative spinal conditions are a major public health burden contributing to the United States (US) having
the highest rate of lumbar spine surgery in the world. Despite surgical advances, up to 40% of patients report
chronic pain and disability after surgery. Physical activity is an important determinant of recovery after spine
surgery. Our own data demonstrate that patients who walk early after spine surgery are more likely to achieve
meaningful improvement in pain, disability, and opioid use. To address physical inactivity and improve long-
term outcomes, our research team recently completed a pilot trial of a Physical Activity intervention to improve
Surgical Spine outcomes. PASS is a mind-body physical activity intervention based on a Brief Action Planning
(BAP) framework that integrates behavioral strategies with pain coping skills and individualized feedback from
wearable technology (Fitbit). BAP involves self-management support through motivational interviewing,
SMART goals, and problem-solving to build self-efficacy and promote behavior change. Pilot work has shown
the benefits of PASS for improving physical activity and long-term pain-related and functional outcomes after
lumbar spine surgery. Therefore, we propose a fully remote two-group randomized controlled trial at three high
volume medical centers in the Southeast, Northeast, and Pacific Northwest regions of the US. We plan to
recruit 220 adults with a degenerative lumbar spine condition undergoing spine surgery. Eligible patients will be
randomized after surgery to (1) 8-session PASS intervention or (2) standard of care physical activity education.
The 8-session PASS intervention is delivered weekly by a physical therapist using a web-based platform.
Remote assessments will be conducted by an evaluator unaware of randomization assignment before surgery
and at 6 and 12 months after surgery. We hypothesize that participants in a remotely delivered mind-body
physical activity intervention will have higher objective physical activity at 6 months (primary outcome) and
better pain, disability, physical function, mental health, and opioid use at 12 months (secondary outcomes)
compared to standard of care physical activity education. Physical activity will be assessed through a triaxial
accelerometer (ActiGraph) and secondary outcomes through validated questionnaires and electronic health
record data on opioid prescriptions. Exploratory data will be collected on depression (8-item Patient Health
Questionnaire), sleep (ActiGraph), and heart rate variability (heart rate monitor) to assess overlapping
mechanisms related to physical activity and pain-related outcomes. This study will be the first to investigate a
mind-body postoperative rehabilitation program that targets multiple pathways for enhancing physical activity in
order to achieve long-term impact after spine surgery. The results of our randomized trial will serve to broadly
disseminate integrative physical and
Istituzione: VANDERBILT UNIVERSITY MEDICAL CENTER
PI: Kristin Archer
Progetto: 1R01AT013630-01
Settori: National Center for Complementary and Integrative Health
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