Physical Activity Intervention for Patients Following Lumbar Spine Surgery

Vanderbilt University Medical Center16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Spinal Degenerative Disorder Spinal Stenosis Spondylosis

Interventions

Physical activity interventionBEHAVIORAL

Participants will 1) receive Fitbit, 2) be enrolled in a secure electronic platform to access Fitbit data, 3) receive 8-week remote counseling by a physical therapist that will include motivational interviewing and creating SMART goals (1 session per week) through a web-based teleconference platform, and 4) receive usual postoperative care directed by their surgeon. The first session will be 45 minutes and sessions 2-8 will be 30 minutes each. During the sessions, participant's confidence in meeting daily step goals will be assessed using a 0-10 scale. If self-reported confidence to meet their goal is \<8, the physical therapist will help participants modify their goal using techniques such as problem-solving, positive statements and affirmations. Progression will be made only if daily steps goals are met for at least 4 out of 7 days a week. If this weekly step goal is not met, a physical therapist will help the participant identify solutions for realistic progression.

Usual careOTHER

Participants will receive postoperative care as determined by their treating surgeon. This includes lifting restrictions, advice to stay active, and oral analgesics as needed. Physical therapy referral will be at the discretion of the surgeon. However, physical therapy is not typically started until 12 weeks after surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Recruitment rate

Proportion of potential eligible participants successfully contacted who agreed to participate and randomized.

Time frame: At 2 weeks after spine surgery

Adherence rate to study protocol at 3 months after spine surgery

Proportion of participants who will complete the assessment at 2 weeks and 3 months after spine surgery.

Time frame: From 2 weeks to 3-months after spine surgery

Adherence rate to study protocol at 6 months after spine surgery

Proportion of participants who will complete the assessment at 2 weeks and 6 months after spine surgery.

Time frame: From 2 weeks to 6-months after spine surgery

Adherence to physical activity intervention

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

Time frame: From 2-weeks to 3-months after spine surgery

Number of adverse events

During the intervention phase, the study physical therapist will document adverse events related to walking to assess safety.

Time frame: From 2-weeks to 3-months after spine surgery

Secondary Outcomes

Oswestry Disability Index

A 10-item questionnaire will be used to measure condition-specific disability that assesses the impact of lumbar spinal disorders on activities of daily living. Each item is measured from 0 to 5, representing low and high disability, respectively. Total score ranges from 0 to 50.