NCT04591249: PASS

Physical Activity Intervention for Patients Following Lumbar Spine Surgery

Completed NA Last updated 31 March 2022

What this trial tests

NA trial testing Physical activity intervention in Spinal Degenerative Disorder in 16 participants. Completed in 1 December 2021.

Timeline

7 October 2020

Primary endpoint
24 September 2021

1 December 2021

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	16
Start date	7 October 2020
Primary completion	24 September 2021
Estimated completion	1 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Physical activity intervention
• Usual care

Conditions studied

• Spinal Degenerative Disorder — all drugs for Spinal Degenerative Disorder →
• Spinal Stenosis — all drugs for Spinal Stenosis →
• Spondylosis — all drugs for Spondylosis →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Spinal Degenerative Disorder or Spinal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Combining Wearable Technology and Telehealth Counseling for Rehabilitation After Lumbar Spine Surgery: Feasibility and Acceptability of a Physical Activity Intervention.
   Master H, Coronado RA, Whitaker S, Block S, et al · · 2024 · cited 13× · PMID 37478463 · DOI 10.1093/ptj/pzad096