Developing a Novel Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Recruitment rate
Study Overview
Brief Summary
There is a critical need to target physical activity during postoperative management to optimize long-term recovery after lumbar spine surgery. The overall objective of this study is to conduct a two-group randomized control trial (RCT) to examine the feasibility and acceptability of a physical activity telehealth intervention delivered by a physical therapist for improving disability, physical function, pain, and physical activity compared to usual care after spine surgery for a degenerative lumbar condition. The physical activity intervention will include wearable technology and remote physical therapist support to counsel patients on a realistic progression of physical activity (steps per day). The central hypothesis is that this 8-week physical activity intervention performed at two weeks after surgery will be feasible and acceptable. The results of our randomized trial will be used to support a large multi-site clinical trial to test the effectiveness and implementation of this intervention
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults age 18 years or older, of both sexes and all races
- •Scheduled for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e., fusion) procedures.
- •Participants will be English speaking due to the feasibility of employing study personnel to deliver and assess the study intervention.
Exclusion Criteria
- •Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy will be excluded because individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration.
- •Patients having surgery for spinal deformity as the primary indication or surgery secondary to pseudarthrosis, trauma, infection, or tumor
- •Prior history of lumbar spine surgery
- •Presence of back and/or lower extremity pain < 3 month
- •History of neurological disorder, resulting in moderate to severe movement dysfunction
- •Unable to provide stable address and access to a telephone indicating the inability to participate in the intervention.
Arms & Interventions
Usual postoperative care
Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.
Intervention: Usual care (Other)
Usual postoperative care + Physical activity intervention
Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention.
Intervention: Physical activity intervention (Behavioral)
Usual postoperative care + Physical activity intervention
Participants randomized to the physical activity intervention group will receive usual postoperative care as determined by their treating surgeon and novel physical activity intervention.
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: At 2 weeks after spine surgery
Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.
Adherence rate to study protocol at 3 months after spine surgery
Time Frame: From 2 weeks to 3-months after spine surgery
Proportion of participants who will complete the assessment at 2 weeks and 3 months after spine surgery.
Adherence rate to study protocol at 6 months after spine surgery
Time Frame: From 2 weeks to 6-months after spine surgery
Proportion of participants who will complete the assessment at 2 weeks and 6 months after spine surgery.
Adherence to physical activity intervention
Time Frame: From 2-weeks to 3-months after spine surgery
Number of weekly step goals completed by participant, which will be examined via Fitabase. In addition, number of weekly Zoom calls completed with the physical therapist will be recorded
Number of adverse events
Time Frame: From 2-weeks to 3-months after spine surgery
During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.
Secondary Outcomes
- Oswestry Disability Index(Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery)
- PROMIS Physical Function(Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery)
- Numeric rating scale for back pain(Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery)
- Numeric rating scale for leg pain(Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery)
- Intensity of physical activity(Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery)
- Physical activity volume(Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery)
- Depressive symptoms(Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery)
- Fear of movement(Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery)
Investigators
Hiral Master
Post-doctoral Research Fellow
Vanderbilt University Medical Center