RecruitingNot ApplicableNCT06193343

Steps Towards Osteoarthritis Prevention

Steps Towards Osteoarthritis Prevention: A Pilot Study


Sponsor

University of Georgia

Enrollment

56 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 40 Years

Inclusion Criteria8

  • 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 Criteria12

  • 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

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Interventions

BEHAVIORALAdaptive 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.


Locations(1)

University of Georgia

Athens, Georgia, United States

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NCT06193343


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