NCT04591249

Physical Activity Intervention for Patients Following Lumbar Spine Surgery

Developing a Novel Physical Activity Intervention for Patients Following Lumbar Spine Surgery (PASS Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is a critical need to target physical activity during postoperative management to optimize long-term recovery after lumbar spine surgery. The overall objective of this study is to conduct a two-group randomized control trial (RCT) to examine the feasibility and acceptability of a physical activity telehealth intervention delivered by a physical therapist for improving disability, physical function, pain, and physical activity compared to usual care after spine surgery for a degenerative lumbar condition. The physical activity intervention will include wearable technology and remote physical therapist support to counsel patients on a realistic progression of physical activity (steps per day). The central hypothesis is that this 8-week physical activity intervention performed at two weeks after surgery will be feasible and acceptable. The results of our randomized trial will be used to support a large multi-site clinical trial to test the effectiveness and implementation of this intervention

Conditions

• Spinal Degenerative Disorder
• Spinal Stenosis
• Spondylosis

Interventions

Type	Name	Description
BEHAVIORAL	Physical activity intervention	Participants will 1) receive Fitbit, 2) be enrolled in a secure electronic platform to access Fitbit data, 3) receive 8-week remote counseling by a physical therapist that will include motivational interviewing and creating SMART goals (1 session per week) through a web-based teleconference platform, and 4) receive usual postoperative care directed by their surgeon. The first session will be 45 minutes and sessions 2-8 will be 30 minutes each. During the sessions, participant's confidence in meeting daily step goals will be assessed using a 0-10 scale. If self-reported confidence to meet their goal is \<8, the physical therapist will help participants modify their goal using techniques such as problem-solving, positive statements and affirmations. Progression will be made only if daily steps goals are met for at least 4 out of 7 days a week. If this weekly step goal is not met, a physical therapist will help the participant identify solutions for realistic progression.
OTHER	Usual care	Participants will receive postoperative care as determined by their treating surgeon. This includes 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: 2020-10-07
• Primary completion: 2021-09-24
• Completion: 2021-12-01
• First posted: 2020-10-19
• Last updated: 2022-03-31

Locations

1 site across 1 country: United States