The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study
Condition: Arthritis; Osteoarthritis; Arthritis Knee; Osteo Arthritis Knee; Knee Injuries; Anterior Cruciate Ligament Tear; Meniscus Tear
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee; Knee Injuries; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Adolescents and young adults who hurt their knees playing sports or doing recreational
      activities can develop joint damage, muscle weakness, inactivity, and weight gain which might
      lead to an increased risk of osteoarthritis (OA), a disabling joint condition in their later
      lives. Despite knowing that muscles and joints benefit from exercise, there is no proven
      exercise-based treatments to delay or even halt the onset of OA after a knee joint injury.

      The current study will assess if a physiotherapist-guided intervention called Stop
      OsteoARthritis (SOAR) improves knee muscle strength, physical inactivity, knee-related
      self-efficacy, and knee-related quality of life in people at risk for osteoarthritis due to a
      past knee injury. A total of 70 former knee injury participants will be randomly assigned to
      two groups. One group will immediately start a 16-week SOAR program, while the second will
      wait for 9-weeks before starting an 8-week SOAR program. Trained physiotherapists will
      deliver the SOAR program with videoconferencing. The study hypothesis is that participating
      in the 8-Week SOAR program will improve the knee muscle strength, physical activity levels,
      knee-related self-efficacy and knee-related quality of life in people discharged from regular
      healthcare after a sports knee injury. The findings will help researchers understand the
      ideal length of the program for a future clinical trial in real-world settings.
    

Detailed description: 
      Purpose:

      The purpose of this study is to evaluate a novel, virtually delivered, PT-guided, knee health
      program (Stop OsteoARthritis - SOAR) for people who have been discharged from regular
      healthcare after a sports knee injury.

      Objectives:

        1. The primary objective of the study is to assess the efficacy of an 8-week SOAR program
           to improve knee muscle strength measured by computerized dynamometry (primary outcome
           and daily average moderate to vigorous physical activity measured by Tri-axial
           Accelerometer (secondary outcome), self-reported knee-specific self-efficacy (secondary
           outcome), and self-reported knee-related quality of life (secondary outcome) in people
           discharged from regular care after sports knee trauma. Several exploratory outcomes will
           also be assessed to inform the design of a future clinical trial.

        2. A secondary objective of this study is to evaluate the feasibility of a protocol for a
           future full-scale clinical trial to assess the effectiveness and implementation of SOAR.
           Both SOAR program and study protocol implementation and practicality outcomes will be
           collected.

        3. A third objective of this study is to inform the optimal length of the SOAR program.

        4. A fourth, exploratory objective, of this study, is to explore the experiences of
           stakeholders (i.e., knee injury participants and physiotherapists) to inform future
           implementation.

      Research Design:

      This is a proof-of-concept, two-armed, open-label, randomized delayed control trial with
      embedded 1:1 interviews. In this design, randomization determines when the intervention is
      provided (immediate or 9-week delay). Consenting eligible knee injury participants will be
      randomly allocated in a 1:1 ratio to immediate intervention (experimental) or delayed
      intervention (control) groups using a computer-generated sequence of random numbers.
      Consenting eligible and physiotherapists will complete Brief Action Planning certification
      and SOAR training before delivering the SOAR program virtually to the knee injury
      participants.

      The immediate study group will be complete an 8-week (weeks 1-8) SOAR program (Knee Camp,
      home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT counseling
      sessions, and optional weekly group-based exercise classes) followed by an additional 8 weeks
      (weeks 10-17) of home-based exercise-therapy and physical activity with tracking, weekly 1:1
      PT counseling sessions, and optional weekly group-based exercise classes. In contrast, after
      a 9-week delay, the delayed study group will complete an 8-week (weeks 10-17) intervention
      (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT
      counseling sessions, and optional weekly group-based exercise classes).

      Knee injury participant outcomes will be evaluated at baseline (T0), 9-weeks (T1-primary
      endpoint to assess efficacy), and 18-weeks (T2- endpoint to inform optimal intervention
      length).

      Physiotherapist participants will be evaluated prior to training, immediately after training,
      and after they have delivered the SOAR program to all knee injury participants that they have
      been assigned in the study.

      Statistical Analysis:

      Descriptive statistics will be calculated for all demographic variables, and observed
      differences (sex, prior injury, injury type, prior treatment, etc.) considered when
      interpreting findings. Randomization integrity will be monitored. Outcomes will be
      disaggregated by sex and gender, and mean differences between T0 and T1, and T1 and T2
      described by the study group. Intention-to-treat analyses will be conducted. Generalized
      linear mixed-effects regression models for longitudinal data (95%CI), controlling for the
      blocking effect, will estimate the effect of an 8-week intervention (IG T1-T0 versus DG
      T1-T0, and DG T2-T1 versus T1-T0) and the delay (IG T1-T0 versus DG T2-T1) for the primary
      outcome (Figure 2).

      In addition, two exploratory analyses will be conducted. To inform the optimal intervention
      length for the future clinical trial, a longitudinal mixed-effects model will be used to
      examine the intervention effect at 16-week. This model will include the following fixed
      effects: 1) the randomization group indicator for baseline difference; 2) indicator variables
      for follow-up assessment time points (9-week and 18-week) to account for secular trend, and;
      3) indicator variables for the lengths of time since intervention initiation (9-week or
      18-week) to estimate effects after these time intervals. The model will also include
      participant-specific random effects to account for repeated measures. To inform the most
      meaningful muscle function outcome for the future clinical trial linear regression (95%CI)
      models, adjusted for age and sex, will be used to identify differences in the association
      between various aspects of knee extensor muscle function (torque, power, rate of force
      development), and composite self-reported knee symptoms and function score.

      Interview recordings with knee injury participants and physiotherapist participants will be
      transcribed verbatim and de-identified. Using a constant comparative approach data will be
      coded and categories developed by comparing and determining meaningful patterns across codes.
      High-order themes will illuminate the relationship between categories. Uniqueness in
      experience by gender will be explored and if identified, data will be reanalyzed in gender
      sub-groups. A detailed audit of analytic decisions will be kept.
    

Intervention name(s): Immediate 8-Week SOAR Program; Delayed 8-Week SOAR Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is an 8-week, virtually delivered, exercise-based, knee health program delivered to knee injury participants by trained physiotherapists. The program has 3 components:
Knee Camp: This includes an interactive education session about knee health, 1:1 knee exam, and 1:1 counseling session to identify Specific, Measurable, Attainable, Relevant, and Time-bound (SMART) weekly home-based exercise-therapy and physical activity goals, Participants are asked to wear Fitbit's® 24-hours/day.
Weekly Home-based Exercise-Therapy and Physical Activity, with Tracking: At home, participants work to meet their exercise-therapy and physical activity goals. Exercises are tracked with an online bespoke form and activity, with a Fitbit.
Weekly PT-guided Exercise-Therapy and Physical Activity Counseling Sessions: Each week participants will attend a 1:1 virtual physiotherapist counseling session to modify SMART goals and have the option to attend a group exercise class.; This is an 8-week, virtually delivered, exercise-based, knee health program delivered to knee injury participants by trained physiotherapists. The program has 3 components:
Knee Camp: This includes an interactive education session about knee health, 1:1 knee exam, and 1:1 counseling session to identify Specific, Measurable, Attainable, Relevant, and Time-bound (SMART) weekly home-based exercise-therapy and physical activity goals, Participants are asked to wear Fitbit's® 24-hours/day.
Weekly Home-based Exercise-Therapy and Physical Activity, with Tracking: At home, participants work to meet their exercise-therapy and physical activity goals. Exercises are tracked with an online bespoke form and activity, with a Fitbit.
Weekly PT-guided Exercise-Therapy and Physical Activity Counseling Sessions: Each week participants will attend a 1:1 virtual physiotherapist counseling session to modify SMART goals and have the option to attend a group exercise class.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized delayed control trial; Knee health; Knee injury; Sport injury; Knee muscle; Self-efficacy; Quality of life; Osteoarthritis