← Back to Search

Telehealth Physical Activity Intervention for Spinal Degeneration (PASS Trial)

N/A
Waitlist Available
Led By Kristin A Swygert, Ph.D.
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months post-surgery
Awards & highlights

PASS Trial Summary

This trial is testing whether a postoperative physical activity intervention that uses wearable technology and remote physical therapist support helps patients recover better than usual care after lumbar spine surgery.

Who is the study for?
This trial is for adults over 18 who are scheduled for a first-time lumbar spine surgery to treat spinal degeneration. They must speak English and have internet access with a smart device or computer. It's not for those having revision surgery, pain less than 3 months, microsurgical techniques only, surgeries due to trauma, infection, tumor or pseudarthrosis, spinal deformity as primary issue, or severe neurological disorders.Check my eligibility
What is being tested?
The study tests if a telehealth physical activity program helps patients recover better after lumbar spine surgery compared to usual care. Half the participants will get wearable tech and remote support from physical therapists over eight sessions; the other half will receive standard postoperative care.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like exercise guidance rather than medication or invasive procedures, side effects may include typical risks associated with physical activity such as muscle soreness or strain.

PASS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for back surgery to treat a degenerative condition.

PASS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean daily post-operative physical activity as measured by an accelerometer.
Secondary outcome measures
Back pain as measured by the Numeric Rating Scale (NRS).
Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain
Disability as measured by the Oswestry Disability Index.
+6 more

PASS Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Participants randomized to usual care will receive postoperative care as determined by their treating surgeon.
Group II: Physical ActivityExperimental Treatment1 Intervention
Participants randomized to the physical activity intervention will receive usual postoperative care and a tele-health physical activity intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical activity intervention
2009
N/A
~3000

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
865 Previous Clinical Trials
673,093 Total Patients Enrolled
Academy of Orthopaedic Physical TherapyUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Kristin A Swygert, Ph.D.Principal InvestigatorVanderbilt University Medical Center

Media Library

Physical activity intervention Clinical Trial Eligibility Overview. Trial Name: NCT04968821 — N/A
Spinal Degeneration Research Study Groups: Physical Activity, Usual Care
Spinal Degeneration Clinical Trial 2023: Physical activity intervention Highlights & Side Effects. Trial Name: NCT04968821 — N/A
Physical activity intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04968821 — N/A
~15 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top