Clinical trial NCT04591249: Physical Activity Intervention for Patients Following Lumbar Spine Surgery
Official title: Developing a Novel Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Degenerative Disorder
Spinal Stenosis
Spondylosis
Keywords: physical activity
wearable technology
behavioral model
funciton
disability
pain
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group, single-center randomized, controlled study in 30 patients undergoing spine surgery for a lumbar degenerative condition to examine the feasibility and acceptability of an 8-week remote physical activity intervention.
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Adults age 18 years or older, of both sexes and all races
2. 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.
3. Participants will be English speaking due to the feasibility of employing study personnel to deliver and assess the study intervention.

Exclusion Criteria:

1. 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.
2. Patients having surgery for spinal deformity as the primary indication or surgery secondary to pseudarthrosis, trauma, infection, or tumor
3. Prior history of lumbar spine surgery
4. Presence of back and/or lower extremity pain \< 3 month
5. History of neurological disorder, resulting in moderate to severe movement dysfunction
6. Unable to provide stable address and access to a telephone indicating the inability to participate in the intervention.

Primary outcomes:
measure: Recruitment rate
timeFrame: At 2 weeks after spine surgery
measure: Adherence rate to study protocol at 3 months after spine surgery
timeFrame: From 2 weeks to 3-months after spine surgery
measure: Adherence rate to study protocol at 6 months after spine surgery
timeFrame: From 2 weeks to 6-months after spine surgery
measure: Adherence to physical activity intervention
timeFrame: From 2-weeks to 3-months after spine surgery
measure: Number of adverse events
timeFrame: From 2-weeks to 3-months after spine surgery
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
measure: PROMIS Physical Function
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
measure: Numeric rating scale for back pain
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
measure: Numeric rating scale for leg pain
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
measure: Intensity of physical activity
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
measure: Physical activity volume
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
measure: Depressive symptoms
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
measure: Fear of movement
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Other outcomes:
measure: Opioid Use
timeFrame: Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kristin R Archer, DPT, PhD
role: STUDY_DIRECTOR
References: