Physical Activity Intervention for Patients Following Lumbar Spine Surgery

NCT04591249 | Completed DMC

• 1 other identifier: 201126
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Degenerative Disorder; Spinal Stenosis; Spondylosis

Keywords

physical activity; wearable technology; behavioral model; funciton; disability; pain

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

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

  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.

  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.

  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

  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.

  From 2-weeks to 3-months after spine surgery

Secondary Outcomes (8)

• 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

Other Outcomes (1)

• Opioid Use

  Preoperative, and at 2 weeks (baseline), 3-, and 6-months after spine surgery

Study Arms (2)

Usual postoperative care

OTHER

Participants randomized to usual care group will receive postoperative care as determined by their treating surgeon.

Other: Usual care

Usual postoperative care + Physical activity intervention

EXPERIMENTAL

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; Other: Usual care

Interventions

Physical activity intervention BEHAVIORAL

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 postoperative care + Physical activity intervention

Usual care OTHER

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.

Usual postoperative care; Usual postoperative care + Physical activity intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Links

• Website that provides brief description of the PASS trial

MeSH Terms

Conditions

Spinal Stenosis; Spondylosis; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin R Archer, DPT, PhD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: October 7, 2020
• Primary Completion: September 24, 2021
• Study Completion: December 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)