STABILITY: Physical Activity Intervention at 7 Years Post-Anterior Cruciate Ligament Reconstruction

NCT05152758 | Active Not Recruiting

• 1 other identifier: STABILITY PARx Sub-Study
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction; Post-traumatic Osteoarthritis

Keywords

physical activity; anterior cruciate ligament reconstruction; osteoarthritis

Outcome Measures

Primary Outcomes (4)

• International Knee Documentation Committee (IKDC)

  This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.

  Baseline

• International Knee Documentation Committee (IKDC)

  This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.

  2 months

• International Knee Documentation Committee (IKDC)

  This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.

  6 months

• International Knee Documentation Committee (IKDC)

  This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.

  12 months

Secondary Outcomes (11)

• Knee Injury and Osteoarthritis Outcome Score

  Baseline

• Knee Injury and Osteoarthritis Outcome Score

  2 months

• Knee Injury and Osteoarthritis Outcome Score

  6 months

• Knee Injury and Osteoarthritis Outcome Score

  12 months

• Ultrasonographic Femoral Trochlear Cartilage Imaging

  Baseline

Study Arms (2)

Usual Care

NO INTERVENTION

Patients will receive the usual care.

Physical Activity Prescription (PARx)

EXPERIMENTAL

Patients will be prescribed technology-based physical activity programming.

Device: PARx

Interventions

PARx DEVICE

Prescription Physical Activity Programming Application

Physical Activity Prescription (PARx)

Eligibility Criteria

• Age: 21 Years - 32 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Related Publications (6)

• Cinque ME, Dornan GJ, Chahla J, Moatshe G, LaPrade RF. High Rates of Osteoarthritis Develop After Anterior Cruciate Ligament Surgery: An Analysis of 4108 Patients. Am J Sports Med. 2018 Jul;46(8):2011-2019. doi: 10.1177/0363546517730072. Epub 2017 Oct 6.

  PMID: 28982255 BACKGROUND

• Ravalli S, Castrogiovanni P, Musumeci G. Exercise as medicine to be prescribed in osteoarthritis. World J Orthop. 2019 Jul 18;10(7):262-267. doi: 10.5312/wjo.v10.i7.262. eCollection 2019 Jul 18.

  PMID: 31363456 BACKGROUND

• Evans J, Nielson JL. Anterior Cruciate Ligament Knee Injuries. 2021 Feb 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. PMID: 29763023.

  BACKGROUND

• Kraus VB, Sprow K, Powell KE, Buchner D, Bloodgood B, Piercy K, George SM, Kraus WE; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Effects of Physical Activity in Knee and Hip Osteoarthritis: A Systematic Umbrella Review. Med Sci Sports Exerc. 2019 Jun;51(6):1324-1339. doi: 10.1249/MSS.0000000000001944.

  PMID: 31095089 BACKGROUND

• Maly MR, Marriott KA, Chopp-Hurley JN. Osteoarthritis year in review 2019: rehabilitation and outcomes. Osteoarthritis Cartilage. 2020 Mar;28(3):249-266. doi: 10.1016/j.joca.2019.11.008. Epub 2019 Dec 23.

  PMID: 31877379 BACKGROUND

• Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.

  PMID: 26606383 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Osteoarthritis

Condition Hierarchy (Ancestors)

Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jane Thornton, MD PhD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 10, 2021
• Study Start: November 1, 2021
• Primary Completion: December 20, 2024
• Study Completion: December 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)