Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion

NCT ID: NCT04906499

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-09-09

Brief 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 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.

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.

Conditions

Anterior Cruciate Ligament Injuries; Exercise; Cartilage, Articular; Knee Injuries; Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical Activity Promotion Group

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.

Group Type: EXPERIMENTAL

Physical Activity Promotion

Intervention Type: BEHAVIORAL

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.

Interventions

Physical Activity Promotion

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Pietrosimone, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Fetzer Hall, University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24553908 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18163497 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21538946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24261774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17106388 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25232663 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18759314 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16896293 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28419817 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24387819 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28653866 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21798015 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25977523 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12801417 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29193888 (View on PubMed)

Pietrosimone B, Nissman D, Padua DA, Blackburn JT, Harkey MS, Creighton RA, Kamath GM, Healy K, Schmitz R, Driban JB, Marshall SW, Jordan JM, Spang JT. Associations between cartilage proteoglycan density and patient outcomes 12months following anterior cruciate ligament reconstruction. Knee. 2018 Jan;25(1):118-129. doi: 10.1016/j.knee.2017.10.005. Epub 2018 Jan 9.

Reference Type: BACKGROUND

PMID: 29329888 (View on PubMed)

Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998 May;30(5):777-81. doi: 10.1097/00005768-199805000-00021.

Reference Type: BACKGROUND

PMID: 9588623 (View on PubMed)

McClain JJ, Sisson SB, Tudor-Locke C. Actigraph accelerometer interinstrument reliability during free-living in adults. Med Sci Sports Exerc. 2007 Sep;39(9):1509-14. doi: 10.1249/mss.0b013e3180dc9954.

Reference Type: BACKGROUND

PMID: 17805082 (View on PubMed)

Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)--validation of a Swedish version. Scand J Med Sci Sports. 1998 Dec;8(6):439-48. doi: 10.1111/j.1600-0838.1998.tb00465.x.

Reference Type: BACKGROUND

PMID: 9863983 (View on PubMed)

Salavati M, Akhbari B, Mohammadi F, Mazaheri M, Khorrami M. Knee injury and Osteoarthritis Outcome Score (KOOS); reliability and validity in competitive athletes after anterior cruciate ligament reconstruction. Osteoarthritis Cartilage. 2011 Apr;19(4):406-10. doi: 10.1016/j.joca.2011.01.010. Epub 2011 Jan 19.

Reference Type: BACKGROUND

PMID: 21255667 (View on PubMed)

Xu X, Tupy S, Robertson S, Miller AL, Correll D, Tivis R, Nigg CR. Successful adherence and retention to daily monitoring of physical activity: Lessons learned. PLoS One. 2018 Sep 20;13(9):e0199838. doi: 10.1371/journal.pone.0199838. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30235221 (View on PubMed)

Adams MA, Sallis JF, Norman GJ, Hovell MF, Hekler EB, Perata E. An adaptive physical activity intervention for overweight adults: a randomized controlled trial. PLoS One. 2013 Dec 9;8(12):e82901. doi: 10.1371/journal.pone.0082901. eCollection 2013.

Reference Type: BACKGROUND

PMID: 24349392 (View on PubMed)

Hurley JC, Hollingshead KE, Todd M, Jarrett CL, Tucker WJ, Angadi SS, Adams MA. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults. JMIR Res Protoc. 2015 Sep 11;4(3):e108. doi: 10.2196/resprot.4856.

Reference Type: BACKGROUND

PMID: 26362511 (View on PubMed)

Kuenze C, Lisee C, Pfeiffer KA, Cadmus-Bertram L, Post EG, Biese K, Bell DR. Sex differences in physical activity engagement after ACL reconstruction. Phys Ther Sport. 2019 Jan;35:12-17. doi: 10.1016/j.ptsp.2018.10.016. Epub 2018 Oct 26.

Reference Type: BACKGROUND

PMID: 30396146 (View on PubMed)

Kuenze C, Cadmus-Bertram L, Pfieffer K, Trigsted S, Cook D, Lisee C, Bell D. Relationship Between Physical Activity and Clinical Outcomes After ACL Reconstruction. J Sport Rehabil. 2019 Feb 1;28(2):180-187. doi: 10.1123/jsr.2017-0186. Epub 2018 Oct 15.

Reference Type: BACKGROUND

PMID: 29140161 (View on PubMed)

Lisee CM, Montoye AHK, Lewallen NF, Hernandez M, Bell DR, Kuenze CM. Assessment of Free-Living Cadence Using ActiGraph Accelerometers Between Individuals With and Without Anterior Cruciate Ligament Reconstruction. J Athl Train. 2020 Sep 1;55(9):994-1000. doi: 10.4085/1062-6050-425-19.

Reference Type: BACKGROUND

PMID: 32818959 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2KR1372103

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

21-0614

Identifier Type: -

Identifier Source: org_study_id