Telehealth Activity Intervention After Lumbar Spine Surgery

NCT04968821 | Completed

• 1 other identifier: 211126
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this randomized controlled study is to examine the preliminary efficacy of a physical activity intervention that includes wearable technology and remote physical therapist support in patients undergoing lumbar spine surgery. Patients will be randomized to receive 8 sessions of a telehealth physical activity intervention (n=30) or usual postoperative care (n=30). The Investigator's central hypothesis is that a postoperative telehealth physical activity intervention will lead to greater improvements in objective physical activity (primary outcome) and patient-reported physical function, disability, and pain (secondary outcomes) compared to usual care in patients undergoing lumbar spine surgery.

Conditions

Spinal Degenerative Disorder

Outcome Measures

Primary Outcomes (1)

• Mean daily post-operative physical activity as measured by an accelerometer.

  Post-operative physical activity will be calculated as the average steps/day over a period of 7 days as measured by accelerometer

  Baseline to 12 months post-surgery

Secondary Outcomes (9)

• Post-operative physical activity as measured by an accelerometer.

  Baseline to 12 months post-surgery

• Physical function as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Physical Function Domain

  Baseline to 12 months post-surgery

• Disability as measured by the Oswestry Disability Index.

  Baseline to 12 months post-surgery

• Back pain as measured by the Numeric Rating Scale (NRS).

  Baseline to 12 months post-surgery

• Leg pain as measured by the Numeric Rating Scale (NRS).

  Baseline to 12 months post-surgery

Study Arms (2)

Physical Activity

EXPERIMENTAL

Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.

Behavioral: Physical activity intervention

Usual Care

OTHER

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

Other: Usual care

Interventions

Physical activity intervention BEHAVIORAL

Participants randomized to the physical activity intervention will receive a Fitbit and be enrolled in Fitabase (Fitbit tracking system). Participants will also participate in 8 tele-health sessions with a physical therapist. Sessions will involve setting weekly physical activity goals and reviewing the participant's physical activity on the Fitbit tracking system.

Physical Activity

Usual care OTHER

Usual postoperative care includes surgeon-directed 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 Care

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
• Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
• English speaking

You may not qualify if:

• Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy
• Patients having surgery for spinal deformity as the primary indication
• Patients having revision surgery
• Patients having surgery for pseudarthrosis, trauma, infection, or tumor
• Presence of back and/or lower extremity pain \< 3 months
• History of neurological disorder, resulting in moderate to severe movement dysfunction
• Unable to provide stable address and access to internet and smartphone or tablet/iPad/computer/laptop indicating the inability to participate in the intervention

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Academy of Orthopaedic Physical Therapy: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Coronado RA, Master H, White DK, Pennings JS, Bird ML, Devin CJ, Buchowski MS, Mathis SL, McGirt MJ, Cheng JS, Aaronson OS, Wegener ST, Archer KR. Early postoperative physical activity and function: a descriptive case series study of 53 patients after lumbar spine surgery. BMC Musculoskelet Disord. 2020 Nov 27;21(1):783. doi: 10.1186/s12891-020-03816-y.

  PMID: 33246446 BACKGROUND

Study Officials

• Kristin Archer, Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Orthopaedics & Rehab

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 20, 2021
• Study Start: June 28, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 20, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)