Steps Towards Osteoarthritis Prevention

Anterior Cruciate Ligament Injuries Clinical Trial

— STOP  

Official title:

Steps Towards Osteoarthritis Prevention: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193343
• Other study ID #: PROJECT00008276
• Secondary ID: K01AR082421
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2024
• Est. completion date: January 30, 2028

Study information

• Verified date: June 2024
• Source: University of Georgia
• Contact: Caroline Lisee, PhD
• Phone: 706-542-713
• Email: caroline.lisee[@]uga.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Osteoarthritis (OA) is a leading cause of disability. Identifying modifiable mechanisms of poor knee joint health development for disease prevention strategies are critical to improving long-term health. Aberrant mechanical loading has been theorized as a primary risk factor for knee OA. Most studies primarily focus on mechanical mechanisms of excessive joint loading in OA development. However, recent evidence suggests that joint underloading may also play a role. The effects of low loading frequency assessed via daily steps in real world settings on knee joint health is an understudied parameter of aberrant mechanical loading in individuals at risk for OA. Individuals with anterior cruciate ligament (ACL) injury who undergo ACL reconstruction (ACLR) surgery are a representative population to assess the effects of low loading frequency on knee joint health because they are at elevated risk for posttraumatic OA development and demonstrate low daily steps compared to uninjured individuals. Therefore, the overall study objective is to determine the mechanistic links between joint loading frequency and comprehensive magnetic resonance imaging (MRI) measures of knee joint cartilage health in individuals 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 which represent equally important, but independent measures of cartilage health. Furthermore, increasing daily steps using a 16-week daily step promotion paradigm in individuals post-ACLR who underload (<7000 daily steps which is predictive of physical inactivity) will recondition cartilage by improving tibiofemoral cartilage composition and strain. The proposed study aims to determine: 1) associations between daily steps with tibiofemoral cartilage composition and strain in ACLR individuals (n=56) using an observational cross-sectional study design, and 2) the effects of increasing daily steps over 16-weeks on tibiofemoral cartilage composition and strain in ACLR individuals with low daily steps (n=28) using a single arm, longitudinal pre-test post-test study design. The proposed study is innovative because it builds on observational studies linking underloading with poor knee joint health and will be the first study to mechanistically determine how altering loading frequency (i.e., increasing daily steps) affects comprehensive in vivo measures of cartilage health in individuals at risk for OA. Successful completion of the proposed study will provide foundational evidence for the development of a future randomized controlled trial to determine the efficacy of an adaptive daily step promotion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 30, 2028
• Est. primary completion date: January 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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 6-24 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 < 7,000 steps per day during the screening phase of aim 2 as assessed using the Actigraph Link monitor

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in daily steps	Change in average steps per day over 7 day physical activity monitor wear from pre-intervention to post-intervention	Pre-intervention (baseline), post-intervention (~18 weeks)
Other	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	Pre-intervention (baseline), post-intervention (~18 weeks)
Primary	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)	pre-intervention (baseline)
Primary	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)	pre-intervention (baseline)
Primary	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)	pre-intervention (baseline)
Primary	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)	pre-intervention (baseline)
Primary	Change in T2 relaxation times in the medial femoral condyle	Change in MRI marker of T2 relaxation times of medial femoral articular cartilage (i.e collagen organization) from pre-intervention to post-intervention	pre-intervention (baseline), post-intervention (~18 weeks)
Primary	Change in T2 relaxation times in the lateral femoral condyle	Change in MRI marker of T2 relaxation times of lateral femoral articular cartilage (i.e collagen organization) from pre-intervention to post-intervention	post-intervention (~18 weeks)
Primary	Change in T2 relaxation times in the medial tibial condyle	Change in MRI marker of T2 relaxation times of medial tibial articular cartilage (i.e collagen organization) from pre-intervention to post-intervention	pre-intervention (baseline), post-intervention (~18 weeks)
Primary	Change T2 relaxation times in the lateral tibial condyle	Change in MRI marker of T2 relaxation times of lateral tibial articular cartilage (i.e collagen organization) from pre-intervention to post-intervention	pre-intervention (baseline), post-intervention (~18 weeks)
Primary	Average cartilage strain in the medial femoral condyle	MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial femoral articular cartilage at pre-intervention (baseline)	pre-intervention (baseline)
Primary	Average cartilage strain in the lateral femoral condyle	MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral femoral articular cartilage at pre-intervention (baseline)	pre-intervention (baseline)
Primary	Average cartilage strain in the medial tibial condyle	MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial tibial articular cartilage at pre-intervention (baseline)	pre-intervention (baseline)
Primary	Average cartilage strain in the lateral tibial condyle	MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral tibial articular cartilage at pre-intervention (baseline)	pre-intervention (baseline)
Primary	Change in average cartilage strain in the medial femoral condyle	Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial femoral articular cartilage from pre-intervention to post-intervention	pre-intervention (baseline), post-intervention (~18 weeks)
Primary	Change in average cartilage strain in the lateral femoral condyle	Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral femoral articular cartilage from pre-intervention to post-intervention	pre-intervention (baseline), post-intervention (~18 weeks)
Primary	Change in average cartilage strain in the medial tibial condyle	Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of medial tibial articular cartilage from pre-intervention to post-intervention	pre-intervention (baseline), post-intervention (~18 weeks)
Primary	Change in average cartilage strain in the lateral tibial condyle	Change in MRI marker of cartilage strain (i.e., acute change in cartilage thickness/resting cartilage thickness) of lateral tibial articular cartilage from pre-intervention to post-intervention	pre-intervention (baseline), post-intervention (~18 weeks)
Primary	Daily steps	Average steps per day over 7 day physical activity monitor wear at pre-intervention (baseline)	Pre-intervention (baseline)