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Steps Towards Osteoarthritis Prevention

NCT06193343 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-04-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • University of Georgia

    lead OTHER

Principal Investigators

  • Caroline Lisee, PhD · University of Georgia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2028-01-30
Completion
2028-01-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193343 on ClinicalTrials.gov