Steps Towards Osteoarthritis Prevention
ConditionAnterior Cruciate Ligament Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorUniversity of Georgia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Adaptive Daily Step Promotion
BehavioralParticipants 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.
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: Interventional GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
pre-intervention (baseline)2
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)
Time frame
pre-intervention (baseline)3
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)
Time frame
pre-intervention (baseline)4
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)
Time frame
pre-intervention (baseline)Other outcomes
1
Change in daily steps
Change in average steps per day over 7 day physical activity monitor wear from pre-intervention to post-intervention
Time frame
Pre-intervention (baseline), post-intervention (~18 weeks)2
Change in Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale
Change in Knee injury Osteoarthritis Outcome Score (KOOS) Quality of Life subscale to measure knee-related quality of life from pre-intervention to post-intervention. A higher score indicates better knee-related quality of life. Min = 0 and Max = 100
Time frame
Pre-intervention (baseline), post-intervention (~18 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Georgia
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov