Introduction. 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 activity are critical for this surgical spine population. The objective of this randomized controlled trial (NCT04968821) was to examine the efficacy of an 8-session physical activity intervention that includes wearable technology and remote physical therapist (PT) support in patients undergoing lumbar spine surgery. The primary outcome was objective physical activity (accelerometer). Secondary outcomes included patient-reported outcomes of physical function (PROMIS PF), disability (ODI), back and leg pain intensity (0-10 NRS), and return to physical activity.
Methods. Patients undergoing surgery for a lumbar degenerative condition using laminectomy with or without fusion were randomized to telehealth physical activity intervention (n=30) or usual postoperative care (n=30). Outcome assessments occurred preoperatively and at 6- and 12-months after surgery. Participants wore an accelerometer for a 7-day period. Questionnaires were completed via a web-based survey. Randomization occurred after surgery and stratified by fusion status. Study personnel responsible for collecting outcomes data were blinded to group assignment. At 2-weeks after surgery, participants randomized to the intervention received a wearable device (Fitbit Inspire HR) and a daily step goal tracking sheet, and were scheduled for telehealth counseling by a licensed PT trained in motivational interviewing. Eight intervention sessions were delivered weekly over a web-based platform (Zoom). Sessions included setting weekly walking goals and reviewing activity with the Fitabase system. Analyses were intent-to-treat using multivariable proportional odds regression for physical activity and linear and logistic regression models for PROs that adjusted for the outcome at baseline and sex. Physical activity was defined as average activity counts and steps per day and time spent in moderate-to-vigorous and sedentary physical activity. The level of significance was set at α=0.05.
Results: The majority of participants had spinal stenosis (62%) and a fusion (63%). Follow-up rate at 12-months was 92%. Intervention participants had higher activity counts per day (OR 2.9; 95%CI 1.06 to 8.2) and time spent in moderate-to-vigorous physical activity (OR 4.2; 95%CI 1.5 to 11.9) at 6-months, and less sedentary activity (OR 0.28; 95%CI 0.11 to 0.75) at 12 months. Statistically significant group differences were found for physical function, back pain, and return to activity at 6-months, and back and leg pain at 12-months. Intervention participants had PROMIS PF 3.9-points higher [95%CI, 0.32 to 7.4], back pain 1.2-points lower [95%CI, -2.4 to -.03] and were 6 times more likely to return to physical activity [95%CI, 1.9 to 21.7] at 6-months and back pain 1.6-points lower [95%CI, -2.7 to -0.53] and leg pain 1.4-points lower [95%CI, -2.8 to -0.06] at 12-months than usual care group.
Discussion: Results from a clinical trial found that a telehealth physical activity intervention improved physical activity, physical function, and pain outcomes after spine surgery. Wearable technology and PT counseling appear to be a promising strategy for promoting physical activity after surgery. Future work is needed to integrate these strategies into clinical practice.