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
| Type | Name | Description |
|---|---|---|
| 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. |
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.