Status:
COMPLETED
Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Anterior Cruciate Ligament Injuries
Exercise
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
Osteoarthritis (OA) is a leading cause of disability worldwide that affects millions of Americans each year. Posttraumatic OA (PTOA) significantly impacts patients after anterior cruciate ligament (AC...
Detailed Description
Osteoarthritis (OA) is a leading cause of disability worldwide resulting in severe limitations in daily activities and chronic pain. It is estimated that 35% of posttraumatic OA (PTOA) cases occur aft...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participants will be included if they:
- Provide informed consent and sign a HIPPA form prior to any study procedures are performed
- Have completed all other formal physical therapy and therapeutic exercise regimens, and will not be engaging in any other formal therapy for their ACLR during the study
- Are between the ages of 18 and 35.
- Underwent an ACLR no earlier than 6 months and no later than 5 years prior to enrollment.
- Demonstrate \< 8,000 steps per day during the screening phase of the study as assessed using the Actigraph GT9X Link monitor.
- Demonstrate clinically relevant-knee symptoms, defined as a Knee Injury and Osteoarthritis Outcomes Score (KOOS) quality of life subscale \< 72.2
- Exclusion Criteria
- Participants will be excluded if:
- The participant underwent an ACLR revision surgery due to a previous ACL graft injury.
- Multiple ligament surgery was indicated at the time of ACLR surgery.
- A lower extremity fracture was suffered during the ACL injury.
- The participant has been diagnosed with osteoarthritis in either knee
- They have a cochlear implant, metal in body, claustrophobia, or history of seizures.
Exclusion
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04906499
Start Date
August 1 2021
End Date
September 9 2022
Last Update
January 29 2024
Active Locations (1)
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1
Fetzer Hall, University of North Carolina
Chapel Hill, North Carolina, United States, 27599