RECRUITING

Steps Towards Osteoarthritis Prevention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Steps Towards Osteoarthritis Prevention: a Pilot Study

Quick Facts

Study Start:2024-09-23
Study Completion:2028-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06193343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * For children, signed and dated informed assent by child and parental permission form by parent/guardian to participate in the study
  3. * Underwent an anterior cruciate ligament reconstruction (ACLR) between 6-24 months prior to enrollment
  4. * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  5. * 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
  6. * Physician clearance for unrestricted activity
  7. * Owning a smartphone
  8. * Demonstrate \< 7,000 steps per day during the screening phase of aim 2 as assessed using the Actigraph Link monitor
  1. * Underwent an ACLR revision surgery due to a previous anterior cruciate ligament (ACL) graft injury
  2. * A multiple ligament surgery was indicated with their ACL injury
  3. * A lower extremity fracture was suffered during the ACL injury
  4. * The participant has previously been diagnosed with any diseases that affect joints is present in either knee including knee osteoarthritis inflammatory arthritis
  5. * Pregnant or plans to become pregnant over next 4 months
  6. * Body mass index (BMI) ≥ 36 kg/m2
  7. * Unable to speak English
  8. * Cochlear implant
  9. * Metal in body (metal fragments, shrapnel, permanent make-up, body piercings that cannot be removed)
  10. * Claustrophobia
  11. * History of seizures
  12. * Pacemaker

Contacts and Locations

Study Contact

Caroline Lisee, PhD
CONTACT
706-542-7137
caroline.lisee@uga.edu

Principal Investigator

Caroline Lisee, PhD
PRINCIPAL_INVESTIGATOR
University of Georgia

Study Locations (Sites)

University of Georgia
Athens, Georgia, 30602
United States

Collaborators and Investigators

Sponsor: University of Georgia

  • Caroline Lisee, PhD, PRINCIPAL_INVESTIGATOR, University of Georgia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23
Study Completion Date2028-01-30

Study Record Updates

Study Start Date2024-09-23
Study Completion Date2028-01-30

Terms related to this study

Additional Relevant MeSH Terms

  • Anterior Cruciate Ligament Injuries