Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion

NCT04906499 | Completed Results

• 2 other identifiers: 21-06142KR1372103
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (13)

• 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)

  pre-intervention (baseline)

• 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)

  post-intervention (~8 weeks)

• 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)

  pre-intervention (baseline)

• 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)

  post-intervention (~8 weeks)

• 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)

  pre-intervention (baseline)

• 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)

  post-intervention (~8 weeks)

• 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)

  pre-intervention (baseline)

• 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)

  post-intervention (~8 weeks)

• 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

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

• 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

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

• 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

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

• 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

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

• 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

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

Secondary Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale

  pre-intervention (baseline)

• Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale

  post-intervention (~8 weeks)

Other Outcomes (2)

• Percentage of Patients Retained at Post-intervention Visit (~8 Weeks) Physical Activity Promotion Intervention Retention

  post-intervention (~8 weeks)

• Percentage of Days Participant is Compliant With Fitbit Monitor Wear (>1,000 Steps Per Day)

  up to post-intervention (~8 weeks)

Study Arms (1)

Physical Activity Promotion Group

EXPERIMENTAL

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.

Behavioral: Physical Activity Promotion

Interventions

Physical Activity Promotion 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.

Physical Activity Promotion Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

Fetzer Hall, University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Motor Activity; Knee Injuries; Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Behavior; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Caroline Lisee, PhD
• Organization: University of North Carolina at Chapel Hill

liseecar@email.unc.edu

919-962-2025

Study Officials

• Brian Pietrosimone, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: August 1, 2021
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: January 29, 2024
• Results First Posted: January 29, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)