Clinical trial NCT05152758: STABILITY: Physical Activity Intervention at 7 Years Post-Anterior Cruciate Ligament Reconstruction
Official title: STABILITY: Physical Activity Intervention at 7 Years Post-Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Post-traumatic Osteoarthritis
Keywords: physical activity
anterior cruciate ligament reconstruction
osteoarthritis
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 196
Sex: ALL
Minimum age (years): 21
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial will randomize up to 196 ACL-reconstruction patients to receive either the standard of care or a physical activity prescription (PARx) at 7 years post-reconstruction in a 1:1 ratio.
Primary purpose: PREVENTION

Brief summary: Anterior cruciate ligament (ACL) ruptures are very common knee injuries amongst youth involved in sports and are often treated through ACL reconstruction surgeries. Unfortunately, up to 50% of individuals who undergo ACL reconstruction develop post-traumatic osteoarthritis (PTOA) in their injured knee by 20 years post-reconstruction causing pain, decreasing mobility, and impacting quality of life in young active individuals. Much remains unknown regarding the secondary prevention of PTOA, and more investigation is necessary to better understand its disease progression post-ACL reconstruction and types of conservative interventions that can prevent or delay its onset.

Physical activity has improved patient-reported outcomes across many different chronic diseases including knee osteoarthritis (OA), and physical activity prescription has been shown to be an effective way to increase patients' levels of physical activity. It has not yet been heavily investigated in the context of post-ACL reconstruction, and individuals often exhibit decreased physical activity after ACL reconstruction which causes suboptimal cartilage health. Thus, physical activity prescription may improve habitual joint loading, leading to improved cartilage health and patient-reported health outcomes.

Detailed description: ACL injuries are extremely common knee injuries sustained by athletes participating in sports involving sudden changes of direction like jumping, cutting and pivoting. Every year, approximately 1 in 3500 individuals injure their ACL. ACL reconstruction surgery is a popular treatment option for young athletes that aims to re-establish knee stability and restore function, enabling high rates of return to sport. Unfortunately, despite reconstruction surgery's short-term benefits, it does not significantly alter the course of post-traumatic osteoarthritis (PTOA) that often develops after sustaining a severe knee injury. In fact, over half of ACL patients present radiographic signs of OA by 20 years post-reconstruction surgery. Individuals with OA often have significantly impaired mobility, functionality, and quality of life, so appropriate rehabilitation protocols and conservative joint management strategies are necessary to improve knee health outcomes post-reconstruction and keep these patients healthy and active for as long as possible.

Physical activity has widely known preventive and therapeutic effects across many chronic diseases such as diabetes, hypertension, heart disease, and obesity. Similarly, there is widespread evidence of high physical activity levels reducing pain and increasing function and health-related quality of life in individuals with knee and hip osteoarthritis, indicating its efficacy as a conservative measure for improving joint health. In contrast, sedentary behaviour increases the risk of OA development and other comorbidities by increasing body mass index (BMI), causing poorer cartilage health, reducing muscle quality, and increasing systemic inflammation. Following ACL reconstruction, individuals are susceptible to adopting more sedentary lifestyles due to a fear of re-injury through movement, evidenced by relatively lower self-reported physical activity levels compared to before injury. While ACL injuries may initiate OA pathogenesis, sedentary behaviour is a modifiable risk factor that can further facilitate disease progression. Since physical activity prescription effectively increases physical activity levels, it offers potential utility for improving knee joint health post-reconstruction surgery and preventing or delaying the onset of PTOA.

Objectives:

1. To examine the effects of physical activity prescription on patient-reported outcomes (KOOS and IKDC scores)
2. To examine the effects of physical activity prescription on femoral trochlear cartilage thickness and echo intensity based on ultrasound imaging over 1 year.
3. To analyze the impact of patients' gait biomechanics on changes in patient-reported outcomes and femoral trochlear cartilage health outcomes due to the physical activity intervention.

Hypotheses:

1. Those assigned to the physical activity prescription group will have higher KOOS and IKDC scores than those in the control group following 1 year.
2. Physical activity prescription will lead to less reductions in echo intensity and heterogeneity of the femoral trochlear cartilage over 1 year.
3. Poorer femoral trochlear cartilage health imaging outcomes (greater reductions in echo intensity and heterogeneity) and lower KOOS and IKDC scores at 1 year will be associated with larger vertical ground reaction forces, smaller knee flexion angles, greater knee adduction moments, smaller knee extensor moments, and larger vertical loading rates of the involved limb.

Eligibility criteria: Inclusion Criteria:

* Subjects following up for 7-year visits as part of the Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study (STAbiLiTY)

Exclusion Criteria:

* Unable/unwilling to follow up for the study period
* Does not have access to the internet and/or smartphone
* Cannot communicate in English
* Unstable medical conditions that would preclude engagement in prescribed physical activity
* Scheduled for second surgery over study period

Primary outcomes:
measure: International Knee Documentation Committee (IKDC)
timeFrame: Baseline
measure: International Knee Documentation Committee (IKDC)
timeFrame: 2 months
measure: International Knee Documentation Committee (IKDC)
timeFrame: 6 months
measure: International Knee Documentation Committee (IKDC)
timeFrame: 12 months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 2 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 6 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 12 months
measure: Ultrasonographic Femoral Trochlear Cartilage Imaging
timeFrame: Baseline
measure: Ultrasonographic Femoral Trochlear Cartilage Imaging
timeFrame: 12 months
measure: Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
timeFrame: Baseline
measure: Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
timeFrame: 2 months
measure: Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
timeFrame: 6 months
measure: Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
timeFrame: 12 months
measure: Three-dimensional Motion-captured Gait Biomechanics Analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Clinic
state: Ontario
Study officials:
affiliation: Western University
name: Jane Thornton, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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