Vanderbilt Clinical Trials

Physical Activity Intervention for Patients Following Lumbar Spine Surgery

Purpose

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

Conditions

Spinal Degenerative Disorder
Spinal Stenosis
Spondylosis

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Care Provider, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Other Usual postoperative care	Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.	Behavioral: Physical activity intervention 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. Other: Usual care 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.
Experimental 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.	Behavioral: Physical activity intervention 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. Other: Usual care 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.

More Details

Status: Completed
Sponsor: Vanderbilt University Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.