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Anterior Cruciate Ligament InjuriesNCT04906499

Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion

A study testing Physical Activity Promotion in people with Anterior Cruciate Ligament Injuries and Exercise, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Osteoarthritis (OA) is a leading cause of disability worldwide that affects millions of Americans each year. Posttraumatic OA (PTOA) significantly impacts patients after anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) with approximately 50% of patients developing PTOA within 20 years of injury or… Read more about this study

Who is it for?
Ages 18 to 35 years
What is being tested?
Physical Activity Promotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
1 Aug 2021to 9 Sep 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants will be included if they:
  • Provide informed consent and sign a HIPPA form prior to any study procedures are performed
  • Have 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
  • Are between the ages of 18 and 35.
  • Underwent an ACLR no earlier than 6 months and no later than 5 years prior to enrollment.
  • Demonstrate < 8,000 steps per day during the screening phase of the study as assessed using the Actigraph GT9X Link monitor.
  • Demonstrate clinically relevant-knee symptoms, defined as a Knee Injury and Osteoarthritis Outcomes Score (KOOS) quality of life subscale < 72.2

Who cannot join

  • Participants will be excluded if:
  • The participant underwent an ACLR revision surgery due to a previous ACL graft injury.
  • Multiple ligament surgery was indicated at the time of ACLR surgery.
  • A lower extremity fracture was suffered during the ACL injury.
  • The participant has been diagnosed with osteoarthritis in either knee
  • They have a cochlear implant, metal in body, claustrophobia, or history of seizures.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fetzer Hall, University of North Carolina

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Osteoarthritis (OA) is a leading cause of disability worldwide that affects millions of Americans each year. Posttraumatic OA (PTOA) significantly impacts patients after anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) with approximately 50% of patients developing PTOA within 20 years of injury or surgery. Knee joint mechanical loading measured via physical activity (i.e. daily steps) is insufficient in individuals after ACLR compared to uninjured individuals. Establishing the beneficial effects of physical activity to promote optimal free-living knee joint mechanical loading and improve knee joint health will aid in the development of cost-effective interventions that prevent PTOA and health burden of the disease.

Read the detailed description

Osteoarthritis (OA) is a leading cause of disability worldwide resulting in severe limitations in daily activities and chronic pain. It is estimated that 35% of posttraumatic OA (PTOA) cases occur after knee injuries and surgeries such as anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR). Optimal free-living mechanical loading, which refers to the forces acting on the knee caused by daily activities, plays an essential role in maintaining knee articular cartilage health. After ACLR, individuals take fewer steps per day as compared to uninjured controls. This results in insufficient free-living mechanical loading to joint tissues and is associated with early PTOA development. Adequate physical activity (PA) is recommended to help reduce risk of PTOA, but it is unclear how changes in PA acutely impact knee joint cartilage health. The overall objective of this pretest-posttest experimental pilot study is to determine how optimizing free-living mechanical loading through PA promotion improves cartilage composition in individuals who demonstrate insufficient free-living mechanical loading after ACLR. PA promotion will be delivered over 8 weeks using commercially available PA monitors and the patients' smartphone to provide daily personalized and achievable step goals to increase daily step counts to a level consistent with healthy PA participation. The hypothesis for aim 1 is that MRI markers of proteoglycan density associated with PTOA development will improve after 8-weeks of PA promotion exposure. Hypothesis for aim 2 is that greater changes in steps per day will be associated with improved proteoglycan density. Change in MRI markers of proteoglycan density and steps per day will be assessed using a pretest-posttest design in 8 adults who are 6 months to 5 years post-ACLR with insufficient mechanical loading (<8,000 steps per day)24 and suboptimal quality of life (quality of life survey<87.5). Outcomes will be collected before (pretest) and after (posttest) 8-weeks of PA promotion. For the PA promotion, participants will receive a text message each morning with a personalized, 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. The proposed work is innovative, in that this study will use a novel combination of outcomes that will lead to unprecedented insight into the influence of PA promotion in mitigating early PTOA development.

Being tested
Physical Activity Promotion
Medical subject headings
Anterior Cruciate Ligament Injuries, Motor Activity, Knee Injuries, Osteoarthritis, Osteoarthritis, Knee, Arthritis, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity PromotionBehavioural

    After enrolling, participants will be outfitted with a Fitbit Charge 2 activity monitor. The monitor will be worn during all waking hours, and compliance will be considered as a day with ≥ 1,000 steps. Participants will complete a 14-day "run-in" observation period while wearing the Fitbit but no PA promotion will occur. Individuals who are noncompliant during the "run in" period (<10 days with <1,000 steps) will be removed. Participants will receive a text message each morning with a personalized, 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.

Study groups in NCT04906499
Study groupRoleWhat they receive
Physical Activity Promotion GroupExperimentalParticipants will receive a text message each morning with a personalized, 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.
Receives: Behavioral: Physical Activity Promotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. T1rho Relaxation Times in the Medial Femoral Condyle at Baseline

    MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)

    Measured: pre-intervention (baseline)

  2. T1rho Relaxation Times in the Medial Femoral Condyle Post-intervention

    MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)

    Measured: post-intervention (~8 weeks)

  3. T1rho Relaxation Times in the Lateral Femoral Condyle at Baseline

    MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e., proteoglycan density) at pre-intervention (baseline)

    Measured: pre-intervention (baseline)

  4. T1rho Relaxation Times in the Lateral Femoral Condyle Post-intervention

    MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)

    Measured: post-intervention (~8 weeks)

  5. T1rho Relaxation Times in the Medial Tibial Condyle at Baseline

    MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)

    Measured: pre-intervention (baseline)

  6. T1rho Relaxation Times in the Medial Tibial Condyle Post-intervention

    MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)

    Measured: post-intervention (~8 weeks)

  7. T1rho Relaxation Times in the Lateral Tibial Condyle at Baseline

    MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)

    Measured: pre-intervention (baseline)

  8. T1rho Relaxation Times in the Lateral Tibial Condyle Post-intervention

    MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)

    Measured: post-intervention (~8 weeks)

  9. Change in Daily Steps

    Change in average steps per day over 7 day physical activity monitor wear pre-intervention (baseline) to approximately 8-weeks after physical activity promotion intervention

    Measured: pre-intervention (baseline), post-intervention (~8 weeks)

  10. Change in T1rho Relaxation Times in the Medial Femoral Condyle

    Change in MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density) from pre-intervention (baseline) to approximately 8-weeks after physical activity promotion intervention

    Measured: pre-intervention (baseline), post-intervention (~8 weeks)

  11. Change in T1rho Relaxation Times in the Medial Tibial Condyle

    Change in MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density) from pre-intervention (baseline) to approximately 8-weeks after physical activity promotion intervention

    Measured: pre-intervention (baseline), post-intervention (~8 weeks)

  12. Change in T1rho Relaxation Times in the Lateral Femoral Condyle

    change in MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e proteoglycan density) from pre-intervention (baseline) to approximately 8-weeks after physical activity promotion intervention

    Measured: pre-intervention (baseline), post-intervention (~8 weeks)

  13. Change in T1rho Relaxation Times in the Lateral Tibial Condyle

    change in MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density) from pre-intervention (baseline) to approximately 8-weeks after physical activity promotion intervention

    Measured: pre-intervention (baseline), post-intervention (~8 weeks)

Secondary outcomes (2)

  1. Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale

    Knee injury Osteoarthritis Outcome Score (KOOS) Quality of Life subscale to measure knee-related quality of life at pre-intervention (baseline). A higher score indicates better knee-related quality of life. Min = 0 and Max = 100

    Measured: pre-intervention (baseline)

  2. Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale

    Knee injury Osteoarthritis Outcome Score Quality of Life subscale (KOOS) Quality of Life subscale to measure knee-related quality of life at post-intervention. A higher score indicates better knee-related quality of life. Min = 0 and Max = 100

    Measured: post-intervention (~8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2021
  2. Study start1 Aug 2021
  3. Primary completion9 Sep 2022
  4. Study completion9 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04906499
Sponsor's protocol ID
21-0614
Other IDs
2KR1372103
Status last verified
Apr 2023
First submitted
25 May 2021
Last updated
29 Jan 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PubMed 24553908

  • Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

    PubMed 18163497

  • Furner SE, Hootman JM, Helmick CG, Bolen J, Zack MM. Health-related quality of life of US adults with arthritis: analysis of data from the behavioral risk factor surveillance system, 2003, 2005, and 2007. Arthritis Care Res (Hoboken). 2011 Jun;63(6):788-99. doi: 10.1002/acr.20430.

    PubMed 21538946

  • Alkan BM, Fidan F, Tosun A, Ardicoglu O. Quality of life and self-reported disability in patients with knee osteoarthritis. Mod Rheumatol. 2014 Jan;24(1):166-71. doi: 10.3109/14397595.2013.854046.

    PubMed 24261774

  • Brown TD, Johnston RC, Saltzman CL, Marsh JL, Buckwalter JA. Posttraumatic osteoarthritis: a first estimate of incidence, prevalence, and burden of disease. J Orthop Trauma. 2006 Nov-Dec;20(10):739-44. doi: 10.1097/01.bot.0000246468.80635.ef.

    PubMed 17106388

  • Luc B, Gribble PA, Pietrosimone BG. Osteoarthritis prevalence following anterior cruciate ligament reconstruction: a systematic review and numbers-needed-to-treat analysis. J Athl Train. 2014 Nov-Dec;49(6):806-19. doi: 10.4085/1062-6050-49.3.35.

    PubMed 25232663

  • Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.

    PubMed 18759314

  • Andriacchi TP, Mundermann A. The role of ambulatory mechanics in the initiation and progression of knee osteoarthritis. Curr Opin Rheumatol. 2006 Sep;18(5):514-8. doi: 10.1097/01.bor.0000240365.16842.4e.

    PubMed 16896293

  • Bell DR, Pfeiffer KA, Cadmus-Bertram LA, Trigsted SM, Kelly A, Post EG, Hart JM, Cook DB, Dunn WR, Kuenze C. Objectively Measured Physical Activity in Patients After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2017 Jul;45(8):1893-1900. doi: 10.1177/0363546517698940. Epub 2017 Apr 18.

    PubMed 28419817

  • Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.

    PubMed 24387819

  • Palmieri-Smith RM, Cameron KL, DiStefano LJ, Driban JB, Pietrosimone B, Thomas AC, Tourville TW, Consortium ATO. The Role of Athletic Trainers in Preventing and Managing Posttraumatic Osteoarthritis in Physically Active Populations: a Consensus Statement of the Athletic Trainers' Osteoarthritis Consortium. J Athl Train. 2017 Jun 2;52(6):610-623. doi: 10.4085/1062-6050-52.2.04.

    PubMed 28653866

  • Tudor-Locke C, Craig CL, Brown WJ, Clemes SA, De Cocker K, Giles-Corti B, Hatano Y, Inoue S, Matsudo SM, Mutrie N, Oppert JM, Rowe DA, Schmidt MD, Schofield GM, Spence JC, Teixeira PJ, Tully MA, Blair SN. How many steps/day are enough? For adults. Int J Behav Nutr Phys Act. 2011 Jul 28;8:79. doi: 10.1186/1479-5868-8-79.

    PubMed 21798015

  • Ingelsrud LH, Granan LP, Terwee CB, Engebretsen L, Roos EM. Proportion of Patients Reporting Acceptable Symptoms or Treatment Failure and Their Associated KOOS Values at 6 to 24 Months After Anterior Cruciate Ligament Reconstruction: A Study From the Norwegian Knee Ligament Registry. Am J Sports Med. 2015 Aug;43(8):1902-7. doi: 10.1177/0363546515584041. Epub 2015 May 14.

    PubMed 25977523

  • Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.

    PubMed 12801417

  • Pfeiffer S, Harkey MS, Stanley LE, Blackburn JT, Padua DA, Spang JT, Marshall SW, Jordan JM, Schmitz R, Nissman D, Pietrosimone B. Associations Between Slower Walking Speed and T1rho Magnetic Resonance Imaging of Femoral Cartilage Following Anterior Cruciate Ligament Reconstruction. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1132-1140. doi: 10.1002/acr.23477. Epub 2018 Jul 4.

    PubMed 29193888

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Promotion in people with Anterior Cruciate Ligament Injuries and Exercise, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

T1rho Relaxation Times in the Medial Femoral Condyle at Baseline (time frame: pre-intervention (baseline)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04906499, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.

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Clinical Trial NCT04906499 | AzTrials