Physical activity intervention to improve surgical spine outcomes (PASS Trial)

BACKGROUND CONTEXT: Studies have shown that up to 80% of patients remain physically inactive after spine surgery. Physical inactivity increases the risk of disability and persistent pain. Innovative interventions that include wearable technology to promote walking are critical for this surgical spine population. PURPOSE: The objective was to examine the efficacy of a physical activity intervention that includes wearable technology and remote physical therapist support in patients undergoing lumbar spine surgery. STUDY DESIGN/SETTING: Randomized controlled trial at an academic medical center (NCT04968821). PATIENT SAMPLE: Patients undergoing surgery for a lumbar degenerative condition using laminectomy with or without fusion were randomized to receive a telehealth physical activity intervention (n=30) or usual postoperative care (n=30). OUTCOME MEASURES: The primary outcome was objective physical activity defined as steps per day (accelerometer). Secondary outcomes included time spent in moderate-to-vigorous physical activity (MVPA) and patient-reported outcomes (PROs) of physical function (PROMIS PF), disability (ODI), back and leg pain intensity (0-10 NRS), and return to physical activity. METHODS: Outcome assessments occurred preoperatively and at 6 months after surgery. Participants wore an accelerometer for a 7-day period. Questionnaires were completed by patients via a web-based survey. Randomization occurred after surgery and was stratified by fusion status. Study personnel responsible for collecting outcomes data were blinded to group assignment. The physical activity intervention included a wearable device (Fitbit Inspire HR) and telehealth counseling by a licensed physical therapist trained in motivational interviewing and goal setting techniques. Eight telehealth sessions were delivered weekly over a web-based platform (Zoom). At 2-weeks after surgery, participants received a Fitbit and daily step goal tracking sheet. The first session with a physical therapist started within 1-week of receiving the Fitbit. Sessions included setting weekly walking goals and reviewing activity with the Fitabase system. Analyses were intent-to-treat using multivariable proportional odds regression models for physical activity and linear and logistic regression models for PROs that adjusted for the outcome at baseline and sex. Partial eta-squared calculated effect size for continuous PROs. The level of significance was set at α=0.05. RESULTS: Study participants had a primary diagnosis of spinal stenosis (62%), spondylolisthesis (26%), and spondylosis (12%) and 63% underwent a fusion. Follow-up rate at 6-months was 92% and 95% for physical activity and PROs, respectively. Intervention adherence was 77% for 8 sessions and 20% for 7 sessions. One person withdrew prior to starting the intervention (3%). No significant group differences were found for steps per day (p > 0.05). Statistically significant group differences were found for MVPA, physical function, back pain, and return to physical activity. Intervention participants had 4.9 increased odds of MVPA [95%CI, 1.7 to 14.4], PROMIS PF score 3.8-points higher [95%CI, 0.32 to 7.4], NRS back pain score 1.2-points lower [95%CI, -2.4 to -0.03] and were 6 times more likely to return to physical activity [95%CI, 1.9 to 21.7] than usual care group at 6-months (p < 0.05). A medium effect size was noted for physical function and back pain (0.07 to 0.08). CONCLUSIONS: Results from a clinical trial found that a telehealth physical activity intervention delivered by a physical therapist improved physical activity, physical function, and back pain outcomes at 6-months. Wearable technology and telehealth counseling appear to be an effective approach for promoting exercise adherence. Future work is needed to help integrate these strategies into clinical practice. FDA Device/Drug Status: This abstract does not discuss or include any applicable devices or drugs.

Duke Scholars

Author Rogelio Adrian Coronado Orthopaedic Surgery