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Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion

Primary Purpose

Anterior Cruciate Ligament Injuries, Exercise, Cartilage, Articular

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Promotion
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fetzer Hall, University of North Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity Promotion Group

Arm Description

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.

Outcomes

Primary Outcome Measures

T1rho relaxation times in the medial femoral condyle
MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)
T1rho relaxation times in the medial femoral condyle
MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)
T1rho relaxation times in the lateral femoral condyle
MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)
T1rho relaxation times in the lateral femoral condyle
MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)
T1rho relaxation times in the medial tibial condyle
MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)
T1rho relaxation times in the medial tibial condyle
MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)
T1rho relaxation times in the lateral tibial condyle
MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)
T1rho relaxation times in the lateral tibial condyle
MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density) at 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
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
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
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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
May 25, 2021
Last Updated
April 4, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04906499
Brief Title
Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion
Official Title
Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Exercise, Cartilage, Articular, Knee Injuries, Osteoarthritis, Osteoarthritis, Knee, Arthritis, Joint Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Promotion Group
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Physical Activity Promotion
Intervention Description
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.
Primary Outcome Measure Information:
Title
T1rho relaxation times in the medial femoral condyle
Description
MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)
Time Frame
pre-intervention (baseline)
Title
T1rho relaxation times in the medial femoral condyle
Description
MRI marker of T1rho relaxation times of medial femoral articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)
Time Frame
post-intervention (~8 weeks)
Title
T1rho relaxation times in the lateral femoral condyle
Description
MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)
Time Frame
pre-intervention (baseline)
Title
T1rho relaxation times in the lateral femoral condyle
Description
MRI marker of T1rho relaxation times of lateral femoral articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)
Time Frame
post-intervention (~8 weeks)
Title
T1rho relaxation times in the medial tibial condyle
Description
MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)
Time Frame
pre-intervention (baseline)
Title
T1rho relaxation times in the medial tibial condyle
Description
MRI marker of T1rho relaxation times of medial tibial articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)
Time Frame
post-intervention (~8 weeks)
Title
T1rho relaxation times in the lateral tibial condyle
Description
MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density) at pre-intervention (baseline)
Time Frame
pre-intervention (baseline)
Title
T1rho relaxation times in the lateral tibial condyle
Description
MRI marker of T1rho relaxation times of lateral tibial articular cartilage (i.e proteoglycan density) at post-intervention (~8 weeks)
Time Frame
post-intervention (~8 weeks)
Title
change in daily steps
Description
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
Time Frame
pre-intervention (baseline), post-intervention (~8 weeks)
Title
change in T1rho relaxation times in the medial femoral condyle
Description
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
Time Frame
pre-intervention (baseline), post-intervention (~8 weeks)
Title
change in T1rho relaxation times in the medial tibial condyle
Description
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
Time Frame
pre-intervention (baseline), post-intervention (~8 weeks)
Title
change in T1rho relaxation times in the lateral femoral condyle
Description
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
Time Frame
pre-intervention (baseline), post-intervention (~8 weeks)
Title
change in T1rho relaxation times in the lateral tibial condyle
Description
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
Time Frame
pre-intervention (baseline), post-intervention (~8 weeks)
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale
Description
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
Time Frame
pre-intervention (baseline)
Title
Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale
Description
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
Time Frame
post-intervention (~8 weeks)
Other Pre-specified Outcome Measures:
Title
physical activity promotion intervention retention
Description
percentage of patients retained at post-intervention visit (~8 weeks)
Time Frame
post-intervention (~8 weeks)
Title
physical activity promotion intervention compliance
Description
percentage of days participant is compliant with fitbit monitor wear (>1,000 steps per day)
Time Frame
up to post-intervention (~8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Pietrosimone, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fetzer Hall, University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
9 to 36 months
IPD Sharing 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.
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Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion

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