Telehealth Activity Intervention After Lumbar Spine Surgery

NCT ID: NCT04968821

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2024-05-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physical Activity

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

Group Type: EXPERIMENTAL

Physical activity intervention

Intervention Type: 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.

Usual Care

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

Group Type: OTHER

Usual care

Intervention Type: 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.

Interventions

Physical activity intervention

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.

Intervention Type: BEHAVIORAL

Usual care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults age 18 years or older

2. Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures

3. English speaking

Exclusion Criteria

1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy

2. Patients having surgery for spinal deformity as the primary indication

3. Patients having revision surgery

4. Patients having surgery for pseudarthrosis, trauma, infection, or tumor

5. Presence of back and/or lower extremity pain < 3 months

6. History of neurological disorder, resulting in moderate to severe movement dysfunction

7. Unable to provide stable address and access to internet and smartphone or tablet/iPad/computer/laptop indicating the inability to participate in the intervention

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academy of Orthopaedic Physical Therapy

UNKNOWN

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kristin Archer

Professor, Department of Orthopaedics & Rehab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Archer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33246446 (View on PubMed)

Other Identifiers

211126

Identifier Type: -

Identifier Source: org_study_id