Steps Towards Osteoarthritis Prevention

NCT06193343 | Recruiting DMC

• 2 other identifiers: PROJECT00008276K01AR082421
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (17)

• T2 relaxation times in the medial femoral condyle

  MRI marker of T2 relaxation times of medial femoral articular cartilage (i.e collagen organization) at pre-intervention (baseline)

  pre-intervention (baseline)

• T2 relaxation times in the lateral femoral condyle

  MRI marker of T2 relaxation times of lateral femoral articular cartilage (i.e collagen organization) at pre-intervention (baseline)

  pre-intervention (baseline)

• T2 relaxation times in the medial tibial condyle

  MRI marker of T2 relaxation times of medial tibial articular cartilage (i.e collagen organization) at pre-intervention (baseline)

  pre-intervention (baseline)

• T2 relaxation times in the lateral tibial condyle

  MRI marker of T2 relaxation times of lateral tibial articular cartilage (i.e collagen organization) at pre-intervention (baseline)

  pre-intervention (baseline)

• Change in T2 relaxation times in the medial femoral condyle

  Change in MRI marker of T2 relaxation times of medial femoral articular cartilage (i.e collagen organization) from pre-intervention to post-intervention

  pre-intervention (baseline), post-intervention (~18 weeks)

• Change in T2 relaxation times in the lateral femoral condyle

  Change in MRI marker of T2 relaxation times of lateral femoral articular cartilage (i.e collagen organization) from pre-intervention to post-intervention

  post-intervention (~18 weeks)

• Change in T2 relaxation times in the medial tibial condyle

  Change in MRI marker of T2 relaxation times of medial tibial articular cartilage (i.e collagen organization) from pre-intervention to post-intervention

  pre-intervention (baseline), post-intervention (~18 weeks)

• Change T2 relaxation times in the lateral tibial condyle

  Change in MRI marker of T2 relaxation times of lateral tibial articular cartilage (i.e collagen organization) from pre-intervention to post-intervention

  pre-intervention (baseline), post-intervention (~18 weeks)

• Average cartilage strain in the medial femoral condyle

  MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial femoral articular cartilage at pre-intervention (baseline)

  pre-intervention (baseline)

• Average cartilage strain in the lateral femoral condyle

  MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral femoral articular cartilage at pre-intervention (baseline)

  pre-intervention (baseline)

• Average cartilage strain in the medial tibial condyle

  MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial tibial articular cartilage at pre-intervention (baseline)

  pre-intervention (baseline)

• Average cartilage strain in the lateral tibial condyle

  MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral tibial articular cartilage at pre-intervention (baseline)

  pre-intervention (baseline)

• Change in average cartilage strain in the medial femoral condyle

  Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial femoral articular cartilage from pre-intervention to post-intervention

  pre-intervention (baseline), post-intervention (~18 weeks)

• Change in average cartilage strain in the lateral femoral condyle

  Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral femoral articular cartilage from pre-intervention to post-intervention

  pre-intervention (baseline), post-intervention (~18 weeks)

• Change in average cartilage strain in the medial tibial condyle

  Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial tibial articular cartilage from pre-intervention to post-intervention

  pre-intervention (baseline), post-intervention (~18 weeks)

• Change in average cartilage strain in the lateral tibial condyle

  Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral tibial articular cartilage from pre-intervention to post-intervention

  pre-intervention (baseline), post-intervention (~18 weeks)

• Daily steps

  Average steps per day over 7 day physical activity monitor wear at pre-intervention (baseline)

  Pre-intervention (baseline)

Other Outcomes (2)

• Change in daily steps

  Pre-intervention (baseline), post-intervention (~18 weeks)

• Change in Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale

  Pre-intervention (baseline), post-intervention (~18 weeks)

Study Arms (1)

Interventional Group

EXPERIMENTAL

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

Behavioral: Adaptive Daily Step Promotion

Interventions

Adaptive Daily Step Promotion BEHAVIORAL

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.

Interventional Group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Caroline Lisee, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Lisee, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single arm, longitudinal pre-test post-test study design

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available for 10 years once all formal data collection, processing, and primary analysis is complete.
• Access Criteria: The data will be available to those who submit a formal written request to the PI and commit to only using the data for researcher purposes unplanned by the investigators.

Locations

US (1)