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Telehealth Activity Intervention After Lumbar Spine Surgery

NCT04968821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

  • Academy of Orthopaedic Physical Therapy

    collaborator UNKNOWN

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Kristin Archer, Ph.D. · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2024-05-01
Completion
2024-05-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04968821 on ClinicalTrials.gov