Steps Towards Osteoarthritis Prevention

Part of paid clinical trials in Athens, Georgia.

Sponsor
University of Georgia
Study ID
NCT06193343
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex
ALL
Age
16 Years - 40 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 23, 2024
Status verified
Apr 2026
Primary completion
Jan 30, 2028
Completion
Jan 30, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional Group
    Participants who meet study criteria and are enrolled in adaptive daily step promotion intervention

Primary Outcome Measure

T2 relaxation times in the medial femoral condyle [ Time Frame: pre-intervention (baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of GeorgiaAthensGeorgia30602
Caroline Lisee, PhD
[email protected]
706-542-7137
Christopher Modlesky, PhD
[email protected]
706-542-4424

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By research site
University of Georgia· Athens, GA

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