Recruiting

Osteoarthritis Prevention

Sponsor:

University of Georgia

Code:

NCT06193343

Conditions

Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Not accepted

Interventions

Adaptive Daily Step Promotion

Study Details

Brief summary:

Optimal knee joint loading, which refers to the forces acting on the knee caused by daily activities such as daily steps, plays an essential role in maintaining knee articular cartilage health and reducing the risk of osteoarthritis (OA). After anterior cruciate ligament reconstruction (ACLR), individuals take fewer daily steps as compared to uninjured controls resulting in insufficient knee joint loading to joint tissues, but it is unclear how changes in daily steps impact knee joint cartilage health in OA development. Therefore, the overall single arm, longitudinal pre-test post-test study objective is to determine the mechanistic links between knee joint loading as measured by daily steps and comprehensive magnetic resonance imaging (MRI) measures of knee joint cartilage health post-ACLR. The central hypothesis is that individuals post-ACLR who take low daily steps will demonstrate deconditioned, less resilient cartilage characterized by poor tibiofemoral cartilage composition and greater cartilage strain.

Conditions

Anterior Cruciate Ligament Injuries

Study ID

NCT06193343

Start date

Sep 23, 2024

Status verified date

Apr, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jan 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • For children, signed and dated informed assent by child and parental permission form by parent/guardian to participate in the study
  • Underwent an anterior cruciate ligament reconstruction (ACLR) between 6-60 months prior to enrollment
  • Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  • 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
  • Physician clearance for unrestricted activity
  • Owning a smartphone
  • Demonstrate < 8,000 steps per day during the screening phase of aim 2 as assessed using the Actigraph Link monitor

Exclusion Criteria:

  • Underwent an ACLR revision surgery due to a previous anterior cruciate ligament (ACL) graft injury
  • A multiple ligament surgery was indicated with their ACL injury
  • A lower extremity fracture was suffered during the ACL injury
  • The participant has previously been diagnosed with any diseases that affect joints is present in either knee including knee osteoarthritis inflammatory arthritis
  • Pregnant or plans to become pregnant over next 4 months
  • Body mass index (BMI) ≥ 36 kg/m2
  • Unable to speak English
  • Cochlear implant
  • Metal in body (metal fragments, shrapnel, permanent make-up, body piercings that cannot be removed)
  • Claustrophobia
  • History of seizures
  • Pacemaker

Study Design

Enrollment

56 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional Group

Participants who meet study criteria and are enrolled in adaptive daily step promotion intervention

Interventions

Adaptive Daily Step Promotion

Participants will wear a Fitbit monitor on their non-dominant wrist during a 10 to 14 day "run-in" screening to capture daily steps reported by the Fitbit but no daily step goals will be sent to the participant. The Fitbit monitor will be worn during all waking hours except water activities, and compliance will be considered as a day with ≥1,000 steps. Next, participants will undergo a 16-week intervention wearing the Fitbit monitor on their wrist and receive a text message each morning with a personalized, adaptive daily step count goal and a link used to confirm receipt of the goal. The preceding 10 days of step data will be rank ordered and the 60th percentile step count will be set as the goal for the next day. Goals will not exceed 10,000 daily steps.

Primary outcome measure

  • T2 relaxation times in the medial femoral condyle [ Time Frame: pre-intervention (baseline) ]
  • T2 relaxation times in the lateral femoral condyle [ Time Frame: pre-intervention (baseline) ]
  • T2 relaxation times in the medial tibial condyle [ Time Frame: pre-intervention (baseline) ]
  • T2 relaxation times in the lateral tibial condyle [ Time Frame: pre-intervention (baseline) ]
  • Change in T2 relaxation times in the medial femoral condyle [ Time Frame: pre-intervention (baseline), post-intervention (~18 weeks) ]
  • Change in T2 relaxation times in the lateral femoral condyle [ Time Frame: post-intervention (~18 weeks) ]
  • Change in T2 relaxation times in the medial tibial condyle [ Time Frame: pre-intervention (baseline), post-intervention (~18 weeks) ]
  • Change T2 relaxation times in the lateral tibial condyle [ Time Frame: pre-intervention (baseline), post-intervention (~18 weeks) ]
  • Average cartilage strain in the medial femoral condyle [ Time Frame: pre-intervention (baseline) ]
  • Average cartilage strain in the lateral femoral condyle [ Time Frame: pre-intervention (baseline) ]
  • Average cartilage strain in the medial tibial condyle [ Time Frame: pre-intervention (baseline) ]
  • Average cartilage strain in the lateral tibial condyle [ Time Frame: pre-intervention (baseline) ]
  • Change in average cartilage strain in the medial femoral condyle [ Time Frame: pre-intervention (baseline), post-intervention (~18 weeks) ]
  • Change in average cartilage strain in the lateral femoral condyle [ Time Frame: pre-intervention (baseline), post-intervention (~18 weeks) ]
  • Change in average cartilage strain in the medial tibial condyle [ Time Frame: pre-intervention (baseline), post-intervention (~18 weeks) ]
  • Change in average cartilage strain in the lateral tibial condyle [ Time Frame: pre-intervention (baseline), post-intervention (~18 weeks) ]
  • Daily steps [ Time Frame: Pre-intervention (baseline) ]

Central Contacts and Locations

Central contacts

Caroline Lisee, PhD

706-542-7137caroline.lisee@uga.edu

Locations

University of Georgia

Recruiting

Athens, Georgia, United States, 30602

Contacts

Caroline Lisee, PhD

706-542-7137caroline.lisee@uga.edu

Christopher Modlesky, PhD

706-542-4424christopher.modlesky@uga.edu

More Information

Sponsor

University of Georgia

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Georgia on 2026-04-29.