Clinical Trials Directory

Trials / Completed

CompletedNCT04968821

Telehealth Activity Intervention After Lumbar Spine Surgery

Telehealth Physical Activity Intervention After Lumbar Spine Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALPhysical activity interventionParticipants 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.
OTHERUsual careUsual 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.

Timeline

Start date
2021-06-28
Primary completion
2024-05-01
Completion
2024-05-20
First posted
2021-07-20
Last updated
2024-05-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04968821. Inclusion in this directory is not an endorsement.