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| Name | Class |
|---|---|
| Arthritis Research Centre of Canada | OTHER |
| The Arthritis Society, Canada | OTHER |
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By 2040, 25% of Canadians will have osteoarthritis, a disabling joint condition. Most people think osteoarthritis only affects older adults, but 50% of the 700,000 Canadian youth who hurt their knee playing sports annually will develop osteoarthritis by 40 years of age. These young people with old knees face knee pain and disability for much of their adult lives, interfering with parenting, work, and recreation. Yet, most do not know about osteoarthritis or how to reduce their risk.
In this clinical trial, people who have torn the Anterior Cruciate ligament in their knee and had reconstruction surgery 9-36 months previously will be randomized to receive either a 6-month virtual education and exercise therapy program called Stop OsteoARthritis (SOAR) or a minimal intervention control program. Researchers will test if those who received the SOAR program have larger gains in knee health, including pain, symptoms, function, and quality of life at 6, 12, and 24 months. Researchers will also use MRIs (baseline and 24 months) to assess how the SOAR program influences knee cartilage degeneration and its cost-effectiveness.
PURPOSE: Assess the effectiveness, efficiency, and implementation of a 6-month evidence-informed, digital (online), education and exercise-therapy program (SOAR - Stop OsteoARthritis) versus a minimal intervention control for people aged 16-35 years at risk of early-onset knee osteoarthritis (OA) due to a first time Anterior Cruciate Ligament Reconstruction (ACLR).
OBJECTIVES:
Primary Effectiveness Objective: Assess if self-reported knee pain, symptoms, function, and QoL (average of the Knee injury and OA Outcome Score pain, other symptoms, function in sport and recreation, and quality of life subscale scores; KOOS4) of people at risk of knee OA who receive SOAR is superior to those receiving a minimal intervention CONTROL at 6 (primary end-point), 12, and 24 months.
Primary Efficiency Objective: Assess the incremental cost-utility ratio of SOAR compared CONTROL (6, 12, 24 months)
Primary Implementation Objective: Assess provider adoption of the SOAR program.
Secondary Effectiveness Objectives:
Secondary Efficiency Objectives:
Secondary Implementation Objectives:
Exploratory Effectiveness Objectives: Explore the superiority of SOAR to CONTROL on the following outcomes (at 6, 12, and 24 months);
RESEARCH DESIGN:
The proposed trial is a two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 randomized controlled trial with embedded cost-utility analyses and 1:1 interviews. This multi-focus design (effectiveness, implementation, efficacy) can accelerate research translation to real-world settings (Type 1: main focus-intervention effectiveness; secondary focus-understand implementation context). This design is appropriate as we have shown feasibility and indirect evidence of SOAR effect, the intervention is minimal risk, and there are no fully powered superiority trials to inform non-inferiority or equivalence designs.
The nature of the interventions do not allow for full blinding (physiotherapists cannot be blinded to treatment). We will employ proven methods from our proof-of-concept RCT to reduce allocation (online randomization module with schedule prepared by an arms-length statistician) and confirmation bias (outcome assessors and data analysts will be blinded to allocation).
STATISTICAL ANALYSES:
Primary analyses will be intent-to-treat (by randomization). Data missing more than 5% will be imputed using multiple imputations by chained equations to avoid bias. To ensure best practice, all outcome and demographic/prognostic variables will be included in imputation equations.
Demographics: Descriptive statistics will be calculated for demographic and potentially prognostic variables (time since injury and ACLR, concomitant injury, ACLR rehabilitation, graft type, reinjury, co-intervention, SES) and observed differences considered or controlled for when interpreting findings.
Effectiveness: SOAR superiority will be assessed with a generalized linear mixed regression model (GLMM) for the primary outcome (KOOS4 at 6 months) adjusted for baseline measure, time since ACLR, and sex. Adjusting for continuous time since ACLR versus stratifying improves power. Similar GLMMs will assess SOAR superiority for continuous secondary (PIH) and exploratory (knee extensor strength, adiposity, physical activity) outcomes at stated time points. Mixed effect logistic regression models (adjusted for the same variables as GLMMs) will assess SOAR superiority for binary secondary outcomes (MRI lesion worsening, achieving PASS) at stated time points. Analyses will yield valid results under the missing at random (MAR) assumption. The robustness of estimates to potential MAR assumption violations will be assessed with state-of-art methods.
Sex/Gender: To explore the effect of gender identity (women, man, gender-diverse) and sex (female, male, intersex) on outcome variables and intervention effect, all outcomes will be described by treatment group stratified by gender (KOOS4, Partner in Health Scale, cost-utility, physical activity, quality of life) or sex (MRI, knee extensor strength, adiposity) at all time points. We will estimate GLMMs and report intervention effect estimates stratified by sex (female, male) or gender (woman, man) as exploratory analyses to inform future studies. As 6% of our preliminary proof-of-concept randomized controlled trial participants identified gender diverse, descriptive statistics will also explore differences by cis and diverse gender.
Implementation: The % of physiotherapists achieving ≥85% on the fidelity checklist and checklist items with ≤70% fidelity will be reported. Provider and participants' responses to survey questions asking about barriers and facilitators of SOAR implementation will be summarized. Interview recordings related to identifying features of participant-provider interactions that facilitate self-management will be transcribed and de-identified. Data will be coded using a constant comparative approach, and categories will be developed by comparing and identifying meaningful patterns across codes. High-order themes will elucidate the relationship between categories. We will look for uniqueness by gender and, if found, reanalyze the data with a gender lens. Analysis trustworthiness and credibility will be fostered through data immersion, memoing, reflexive journaling, and team discussions. An audit of analytic decisions will be kept.
Efficiency outcome: Incremental cost-utility ratio will be estimated as (Cost_SOAR - Cost_CONTROL) ⁄(∆QALY_SOAR - ∆QALY_CONTROL) for the intervention and 6-month post-intervention period using nested imputation and nonparametric bootstrapping to model uncertainty around cost and QALY estimates. The contribution of each cost item to total healthcare resource use will be described by group, gender, and compliance (full, partial).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stop OsteoARthritis (SOAR) program | Experimental | Participants with a first-time ACL tear followed by reconstruction surgery randomized to the SOAR program group will complete a 6-month SOAR program (one-time Knee Camp, weekly home-based exercise therapy and physical activity with tracking, weekly 1:1 physiotherapist counseling sessions, and optional weekly group-based exercise classes) Consented trained physiotherapists will deliver the SOAR program throughout the study period to one or more SOAR program participants. Physiotherapists and SOAR participants will be randomly paired. |
|
| Living Well after ACLR | Active Comparator | Participants with a first-time ACL tear followed by reconstruction surgery randomized to the minimal control (Living Well after ACLR) group will complete a 6-month minimal intervention control program (educational video, workbook, activity tracking, and one 1:1 physiotherapist counseling session). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stop OsteoARthritis (SOAR) program | Behavioral | The SOAR program is a 6-month, online-delivered (videoconferencing), PT-guided knee health program which consists of;
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (ACL tear participants) | Patient partners identify pain, function and quality of life, which can be impaired up to 10-years post-ACLR, as priority outcomes. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a valid and reliable patient-reported outcome measure (PROM) with sub-scales for knee pain (9-items), other symptoms (7-items), function in daily living (ADL; 17-items), function in sport/recreation (5-items), and quality of life (4-items) across injury and OA populations. Each subscale item is scored on a 5-point scale and individual subscale items summed and transformed to a 0-100 scale with higher scores indicating better outcome. The KOOS4 which is an average of 4 sub-scales (excluding ADL) is a recommended and accepted primary outcome for ACLR RCTs and was responsive in our proof of concept RCT. | Change from baseline KOOS score at 6 months (ACL tear participants) |
| Incremental cost-utility ratio over 6 months (efficiency outcome) | To assess SOARs value for money (health systems perspective) we will estimate the incremental cost/mean change in Quality-Adjusted Life Years (QALY) gained by SOAR versus CONTROL at 6 months. Costs will be estimated with the Health Resource Utilization questionnaire (HRU) as the study population often uses resources not captured in administrative data and evidence of good agreement between administrative and prospectively collected HRU data. The HRU captures provider visits, hospital admissions, lab and diagnostic tests and medication use. QALYs will be estimated from health-related quality of life (EQ-5D-5L) using area under the curve analysis. The EQ-5D-5L is widely used for cost-utility analyses in OA, and assesses 5 levels across 5 health domains to produce a health state profile using Canadian conversion tariffs. | Incremental cost-utility ratio at 6 months |
| Provider adoption of SOAR over 6 months (implementation outcome) (physiotherapist participants) | A 40-item fidelity checklist, refined in our proof-of-concept RCT, will be applied to all video-recorded 1:1 counseling sessions for 4 participants per PT, and the median % fidelity for each PT and checklist item reported. Items reaching ≤70% will be identified and inform the development of PT training modules to facilitate future evaluation and implementation. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptable Symptom State over 6 months (ACL tear participants) | To help interpret the clinical relevance of the KOOS4, the percentage of participants in both study groups to reach KOOS4 and KOOS sub-scale Patient Acceptable Symptom State (PASS) scores (KOOS4 79; pain 89; symptoms 83; ADL 95, sport 72; QoL 73) will be reported. | Change from baseline patient acceptable symptom state score at 6 months (ACL tear participants) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported knee-related pain, symptoms, function in sport and quality of life over 12 months (ACL tear participants) | Patient partners identify pain, function and quality of life, which can be impaired up to 10-years post-ACLR, as priority outcomes. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a valid and reliable patient-reported outcome measure (PROM) with sub-scales for knee pain (9-items), other symptoms (7-items), function in daily living (ADL; 17-items), function in sport/recreation (5-items), and quality of life (4-items) across injury and OA populations. Each subscale item is scored on a 5-point scale and individual subscale items summed and transformed to a 0-100 scale with higher scores indicating better outcome. The KOOS4 which is an average of 4 sub-scales (excluding ADL) is a recommended and accepted primary outcome for ACLR RCTs and was responsive in our proof of concept RCT. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jackie L Whittaker, BScPT, PhD | Contact | 604-202-1362 | jackie.whittaker@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jackie L Whittaker, BScPT, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis Research Canada | Recruiting | Vancouver | British Columbia | V5Y 3P2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bombardier C, Hawker G, Mosher D. The Impact of Arthritis in Canada: Today and Over the Next 30 Years. Arthritis Alliance of Canada. Fall 2011. | ||
| 30797228 | Background | Ackerman IN, Bohensky MA, Zomer E, Tacey M, Gorelik A, Brand CA, de Steiger R. The projected burden of primary total knee and hip replacement for osteoarthritis in Australia to the year 2030. BMC Musculoskelet Disord. 2019 Feb 23;20(1):90. doi: 10.1186/s12891-019-2411-9. | |
| 27159532 |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D000070598 | Anterior Cruciate Ligament Injuries |
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
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The proposed trial is a two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 RCT.
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| Living Well after ACLR program | Behavioral | Participants in the minimal intervention CONTROL group will receive access to a 30-minute educational video (knee anatomy, ACLR information, general exercise, physical activity, and goal-setting principles), a best practice workbook, one video-recorded virtual session with a physiotherapist (naïve to SOAR) who will explain the booklet and answer questions but not volunteer information beyond the video or booklet and the same wrist-worn activity tracker as the experimental group. |
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| Percent fidelity at 6 months (physiotherapist participants) |
| Self-reported perceived self-management over 6 months (ACL tear participants) | The 12 item Partner in Health Scale will be used to measure perceived self-management (active involvement to self-manage a chronic condition). Each item is scored on a 0-9 point Likert scale. Scores on individual items are summed to produce a total score ranging between 0 and 96, with 0 representing no perceived self-management and 96 representing full perceived self-management. The total time for this questionnaire is 3 minutes. The Partner in Health Scale is valid and reliable across numerous chronic conditions. | Change from baseline self-reported perceived self-management at 6 months (ACL tear participants) |
| Osteoarthritis MRI features over 24 months (ACL tear participants) | MRI features of OA (cartilage defect, bone marrow lesions) are important for early disease staging and common after ACLR. The impact of exercise on these outcomes post-ACLR is unknown. The valid semi-quantitative MRI OA knee score (MOAKS) will be applied to 3D proton-density (PD) gradient MRI sequences (3T scanner, Philips Elition, 8-channel knee coil). Positioning aids will immobilize the knee to ensure consistent scans. Radiology fellows will conduct MOAKS ratings blinded to group allocation. OA feature worsening will be defined as an increase in the size of the lesion using established methods. | Change from baseline MRI at 24 months (ACL tear participants) |
| Health resource use costs over 24 months | Monthly health resource use costs (HRU) will be reported over the 24-month study period. | Health resource use costs over 24 months |
| Intervention delivery costs over 6 months | The cost to deliver the SOAR and CONTROL (Living Well with ACLR) interventions will be tracked and reported. | Intervention delivery costs over 6 months |
| Participant perceived barriers and facilitators of program delivery over 6 months (ACL tear participants) | On completion of the intervention, participants will receive a follow-up survey which will include questions to capture information about their perceived barriers and facilitators of program delivery, and therapeutic alliance with their PT (Consultation and Relational Empathy measure (CARE)). | Follow-up surveys will take place at 6 months (ACL tear participants) |
| Provider perceived barriers and facilitators of program delivery over 6 months (physiotherapist participants) | After PT's are done delivering the SOAR program they will receive a follow-up survey including questions to capture information about their perceived barriers and facilitators of SOAR program delivery, SOAR and BAP training, confidence in BAP, SMART goal setting, shared decision making, virtual PT delivery, and perceived impacts on patient and clinic flow. | Follow-up surveys will take place at 6 months (physiotherapist participants) |
| Features of PT counselling that promote self-management over 6 months (ACL tear participants) | Semi-structured 1:1 interviews will be conducted with a purposive maximum variation sample (gender, age, adherence, time since injury) of 15-20 participants. Using video-cued narrative reflection, participants will self-select meaningful exchanges with their PT that promoted self-management while viewing a Knee Camp recording and a random weekly counselling session. Participants will be able to pause and rewind the recording to identify, and elaborate on significant moments. A definition of self-management and context-specific examples will be provided. Probe and prompts will provide elaboration. Field notes will be taken, and interviews recorded. Ongoing analyses will inform sampling, and data collection will cease when no new themes are identified. Video-recorded healthcare interactions are acceptable and provide valuable practice insights. Video-cued interviews yield rich data as participants simultaneously identify, engage and reflect on their lived experience. | 1:1 interviews will be conducted at 6 months (ACL tear participants) |
| Change from baseline KOOS score at 12 months (ACL tear participants) |
| Self-reported knee-related pain, symptoms, function in sport and quality of life over 24 months (ACL tear participants) | Patient partners identify pain, function and quality of life, which can be impaired up to 10-years post-ACLR, as priority outcomes. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a valid and reliable patient-reported outcome measure (PROM) with sub-scales for knee pain (9-items), other symptoms (7-items), function in daily living (ADL; 17-items), function in sport/recreation (5-items), and quality of life (4-items) across injury and OA populations. Each subscale item is scored on a 5-point scale and individual subscale items summed and transformed to a 0-100 scale with higher scores indicating better outcome. The KOOS4 which is an average of 4 sub-scales (excluding ADL) is a recommended and accepted primary outcome for ACLR RCTs and was responsive in our proof of concept RCT. | Change from baseline KOOS score at 24 months (ACL tear participants) |
| Incremental cost-utility ratio over 12 months | To assess SOARs value for money (health systems perspective) we will estimate the incremental cost/mean change in Quality-Adjusted Life Years (QALY) gained by SOAR versus CONTROL at 12 months. Costs will be estimated with the Health Resource Utilization questionnaire (HRU) as the study population often uses resources not captured in administrative data and evidence of good agreement between administrative and prospectively collected HRU data. The HRU captures provider visits, hospital admissions, lab and diagnostic tests and medication use. QALYs will be estimated from health-related quality of life (EQ-5D-5L) using area under the curve analysis. The EQ-5D-5L is widely used for cost-utility analyses in OA, and assesses 5 levels across 5 health domains to produce a health state profile using Canadian conversion tariffs. | Incremental cost-utility ratio at 12 months |
| Incremental cost-utility ratio over 24 months | To assess SOARs value for money (health systems perspective) we will estimate the incremental cost/mean change in Quality-Adjusted Life Years (QALY) gained by SOAR versus CONTROL at 24 months. Costs will be estimated with the Health Resource Utilization questionnaire (HRU) as the study population often uses resources not captured in administrative data and evidence of good agreement between administrative and prospectively collected HRU data. The HRU captures provider visits, hospital admissions, lab and diagnostic tests and medication use. QALYs will be estimated from health-related quality of life (EQ-5D-5L) using area under the curve analysis. The EQ-5D-5L is widely used for cost-utility analyses in OA, and assesses 5 levels across 5 health domains to produce a health state profile using Canadian conversion tariffs. | Incremental cost-utility ratio at 24 months |
| Patient Acceptable Symptom State over 12 months (ACL tear participants) | To help interpret the clinical relevance of the KOOS4, the percentage of participants in both study groups to reach KOOS4 and KOOS sub-scale Patient Acceptable Symptom State (PASS) scores (KOOS4 79; pain 89; symptoms 83; ADL 95, sport 72; QoL 73) will be reported. | Change from baseline Patient Acceptable Symptom State score at 12 months (ACL tear participants) |
| Patient Acceptable Symptom State over 24 months (ACL tear participants) | To help interpret the clinical relevance of the KOOS4, the percentage of participants in both study groups to reach KOOS4 and KOOS sub-scale Patient Acceptable Symptom State (PASS) scores (KOOS4 79; pain 89; symptoms 83; ADL 95, sport 72; QoL 73) will be reported. | Change from baseline Patient Acceptable Symptom State score at 24 months (ACL tear participants) |
| Self-reported perceived self-management over 12 months (ACL tear participants) | The 12 item Partner in Health Scale will be used to measure perceived self-management (active involvement to self-manage a chronic condition). Each item is scored on a 0-9 point Likert scale. Scores on individual items are summed to produce a total score ranging between 0 and 96, with 0 representing no perceived self-management and 96 representing full perceived self-management. The total time for this questionnaire is 3 minutes. The Partner in Health Scale is valid and reliable across numerous chronic conditions. | Change from baseline self-reported perceived self-management at 12 months (ACL tear participants) |
| Perceived self-management over 24 months (ACL tear participants) | The 12 item Partner in Health Scale will be used to measure perceived self-management (active involvement to self-manage a chronic condition). Each item is scored on a 0-9 point Likert scale. Scores on individual items are summed to produce a total score ranging between 0 and 96, with 0 representing no perceived self-management and 96 representing full perceived self-management. The total time for this questionnaire is 3 minutes. The Partner in Health Scale is valid and reliable across numerous chronic conditions. | Change from baseline self-reported perceived self-management at 24 months (ACL tear participants) |
| Self-reported function over 6 months (ACL tear participants) | The 3 item Patient Specific Functional Scale will be used to identify, quantify and assess changes in functional limitations that are most relevant to participants. This scale prompts participants to identify three activities important to them and rate their ability to perform each activity on a 10-point numerical rating scale. Individual scale scores are summed and transformed to a 0-100 scale with higher scores indicating better outcomes. The total time for this questionnaire is 3 minutes. The Patient-Specific Functional Scale is valid and reliable for use in persons with a knee injury. | Change from baseline self-reported function at 6 months (ACL tear participants) |
| Self-reported function over 12 months (ACL tear participants) | The 3 item Patient Specific Functional Scale will be used to identify, quantify and assess changes in functional limitations that are most relevant to participants. This scale prompts participants to identify three activities important to them and rate their ability to perform each activity on a 10-point numerical rating scale. Individual scale scores are summed and transformed to a 0-100 scale with higher scores indicating better outcomes. The total time for this questionnaire is 3 minutes. The Patient-Specific Functional Scale is valid and reliable for use in persons with a knee injury. | Change from baseline self-reported function at 12 months (ACL tear participants) |
| Self-reported function over 24 months (ACL tear participants) | The 3 item Patient Specific Functional Scale will be used to identify, quantify and assess changes in functional limitations that are most relevant to participants. This scale prompts participants to identify three activities important to them and rate their ability to perform each activity on a 10-point numerical rating scale. Individual scale scores are summed and transformed to a 0-100 scale with higher scores indicating better outcomes. The total time for this questionnaire is 3 minutes. The Patient-Specific Functional Scale is valid and reliable for use in persons with a knee injury. | Change from baseline self-reported function at 24 months (ACL tear participants) |
| Self-reported knee-specific self-efficacy over 6 months (ACL tear participants) | Self-efficacy, or one's belief in their own ability to organize and execute the actions required to manage a prospective situation, can predict health behaviours including exercise participation. The KSES is a valid and reliable measure of knee-specific self-efficacy in people with a sport-related knee injury in the previous 5-years. The KSES consists of 22 items organized into 2 sub-scales (present and future self-efficacy). Each item is scored on an 0-10-point Likert scale, with 0 indicating no confidence and 10 indicating full confidence. Individual item scores are summed to produce a total score. Higher scores indicate higher levels of self-efficacy. | Change from baseline self-reported knee-specific self-efficacy at 6 months (ACL tear participants) |
| Self-reported knee-specific self-efficacy over 12 months (ACL tear participants) | Self-efficacy, or one's belief in their own ability to organize and execute the actions required to manage a prospective situation, can predict health behaviours including exercise participation. The KSES is a valid and reliable measure of knee-specific self-efficacy in people with a sport-related knee injury in the previous 5-years. The KSES consists of 22 items organized into 2 sub-scales (present and future self-efficacy). Each item is scored on an 0-10-point Likert scale, with 0 indicating no confidence and 10 indicating full confidence. Individual item scores are summed to produce a total score. Higher scores indicate higher levels of self-efficacy. | Change from baseline self-reported knee-specific self-efficacy at 12 months (ACL tear participants) |
| Self-reported knee-specific self-efficacy over 24 months (ACL tear participants) | Self-efficacy, or one's belief in their own ability to organize and execute the actions required to manage a prospective situation, can predict health behaviours including exercise participation. The KSES is a valid and reliable measure of knee-specific self-efficacy in people with a sport-related knee injury in the previous 5-years. The KSES consists of 22 items organized into 2 sub-scales (present and future self-efficacy). Each item is scored on an 0-10-point Likert scale, with 0 indicating no confidence and 10 indicating full confidence. Individual item scores are summed to produce a total score. Higher scores indicate higher levels of self-efficacy. | Change from baseline self-reported knee-specific self-efficacy at 24 months (ACL tear participants) |
| Self-reported fear of movement and re-injury over 6 months (ACL tear participants) | The 11 item Tampa Scale of Kinesiophobia will be used to measure self-reported fear of movement and re-injury. Each item is scored on a 0-4 point Likert-scale, with 0 indicating no fear of movement and 4 indicating greater fear of movement. The item scores are summed to produce a total score ranging between 0 and 44, with higher values indicating a higher degree of fear of movement. The total time for this questionnaire is 3 minutes. The Tampa Scale of Kinesiophobia has evidence of known-group validity (scores discriminated between athletes who returned and did not return to pre-injury sports participation level after knee trauma). | Change from baseline self-reported fear of movement and re-injury at 6 months (ACL tear participants) |
| Self-reported fear of movement and re-injury over 12 months (ACL tear participants) | The 11 item Tampa Scale of Kinesiophobia will be used to measure self-reported fear of movement and re-injury. Each item is scored on a 0-4 point Likert-scale, with 0 indicating no fear of movement and 4 indicating greater fear of movement. The item scores are summed to produce a total score ranging between 0 and 44, with higher values indicating a higher degree of fear of movement. The total time for this questionnaire is 3 minutes. The Tampa Scale of Kinesiophobia has evidence of known-group validity (scores discriminated between athletes who returned and did not return to pre-injury sports participation level after knee trauma). | Change from baseline self-reported fear of movement and re-injury at 12 months (ACL tear participants) |
| Self-reported fear of movement and re-injury over 24 months (ACL tear participants) | The 11 item Tampa Scale of Kinesiophobia will be used to measure self-reported fear of movement and re-injury. Each item is scored on a 0-4 point Likert-scale, with 0 indicating no fear of movement and 4 indicating greater fear of movement. The item scores are summed to produce a total score ranging between 0 and 44, with higher values indicating a higher degree of fear of movement. The total time for this questionnaire is 3 minutes. The Tampa Scale of Kinesiophobia has evidence of known-group validity (scores discriminated between athletes who returned and did not return to pre-injury sports participation level after knee trauma). | Change from baseline self-reported fear of movement and re-injury at 24 months (ACL tear participants) |
| Change in Knee Extension Power over 6 months (ACL tear participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate knee extension power (Watts). After completing the protocol for normalized peak concentric knee extension and flexion torque the participants' knee joint will be fixed in 60 degrees of sagittal plane flexion. After three practice trials and a 30-second rest, participants will be instructed to straighten their knee as hard and as fast as they can for five seconds. This will be repeated five times with a 30-second rest period between each repetition. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle power. | Change from baseline knee extensor muscle power at 6 months (ACL tear participants) |
| Change in Knee Extension Power over 12 months (ACL tear participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate knee extension power (Watts). After completing the protocol for normalized peak concentric knee extension and flexion torque the participants' knee joint will be fixed in 60 degrees of sagittal plane flexion. After three practice trials and a 30-second rest, participants will be instructed to straighten their knee as hard and as fast as they can for five seconds. This will be repeated five times with a 30-second rest period between each repetition. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle power. | Change from baseline knee extensor muscle power at 12 months (ACL tear participants) |
| Change in Knee Extension Power over 24 months (ACL tear participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate knee extension power (Watts). After completing the protocol for normalized peak concentric knee extension and flexion torque the participants' knee joint will be fixed in 60 degrees of sagittal plane flexion. After three practice trials and a 30-second rest, participants will be instructed to straighten their knee as hard and as fast as they can for five seconds. This will be repeated five times with a 30-second rest period between each repetition. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle power. | Change from baseline knee extensor muscle power at 24 months (ACL tear participants) |
| Change in Knee Flexion Power over 6 months (ACL tear participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate knee flexion power (Watts). After completing the protocol for normalized peak concentric knee extension and flexion torque the participants' knee joint will be fixed in 60 degrees of sagittal plane flexion. After three practice trials and a 30-second rest, participants will be instructed to bend their knee as hard and as fast as they can for five seconds. This will be repeated five times with a 30-second rest period between each repetition. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle power. | Change from baseline knee extensor muscle power at 6 months (ACL tear participants) |
| Change in Knee Flexion Power over 12 months (ACL tear participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate knee flexion power (Watts). After completing the protocol for normalized peak concentric knee extension and flexion torque the participants' knee joint will be fixed in 60 degrees of sagittal plane flexion. After three practice trials and a 30-second rest, participants will be instructed to bend their knee as hard and as fast as they can for five seconds. This will be repeated five times with a 30-second rest period between each repetition. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle power. | Change from baseline knee extensor muscle power at 12 months (ACL tear participants) |
| Change in Knee Flexion Power over 24 months (ACL tear participants) | A computerized dynamometer (Biodex®) will be used to assess and calculate knee flexion power (Watts). After completing the protocol for normalized peak concentric knee extension and flexion torque the participants' knee joint will be fixed in 60 degrees of sagittal plane flexion. After three practice trials and a 30-second rest, participants will be instructed to bend their knee as hard and as fast as they can for five seconds. This will be repeated five times with a 30-second rest period between each repetition. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle power. | Change from baseline knee extensor muscle power at 24 months (ACL tear participants) |
| Change in Daily Average Moderate to Vigorous Physical Activity over 6 months (ACL tear participants) | A small, lightweight hip worn wearable triaxial accelerometer (ActiGraph GT3X®) will be used to assess physical activity. Participants will be asked to wear this device (attached via an elastic belt around their waist), for a period of 7 consecutive days removing only for bathing/swimming activities. The average number of 10-minute moderate-to-vigorous physical activity bouts over the 7-day period will be calculated. Accelerometry is a valid measure of physical activity in youth and young adult populations. | Change from baseline daily average moderate to vigorous physical activity at 6 months (ACL tear participants) |
| Change in Daily Average Moderate to Vigorous Physical Activity over 12 months (ACL tear participants) | A small, lightweight hip worn wearable triaxial accelerometer (ActiGraph GT3X®) will be used to assess physical activity. Participants will be asked to wear this device (attached via an elastic belt around their waist), for a period of 7 consecutive days removing only for bathing/swimming activities. The average number of 10-minute moderate-to-vigorous physical activity bouts over the 7-day period will be calculated. Accelerometry is a valid measure of physical activity in youth and young adult populations. | Change from baseline daily average moderate to vigorous physical activity at 12 months (ACL tear participants) |
| Change in Daily Average Moderate to Vigorous Physical Activity over 24 months (ACL tear participants) | A small, lightweight hip worn wearable triaxial accelerometer (ActiGraph GT3X®) will be used to assess physical activity. Participants will be asked to wear this device (attached via an elastic belt around their waist), for a period of 7 consecutive days removing only for bathing/swimming activities. The average number of 10-minute moderate-to-vigorous physical activity bouts over the 7-day period will be calculated. Accelerometry is a valid measure of physical activity in youth and young adult populations. | Change from baseline daily average moderate to vigorous physical activity at 24 months (ACL tear participants) |
| Change in Self-Reported Physical Activity over 6 months (ACL tear participants) | The 4 item Godin Leisure Time Questionnaire will be used to measure self-reported physical activity. Using the number of 15-minute bouts of mild, moderate, and strenuous physical activity a participant engages in over a typical seven-day period weekly metabolic equivalents of physical activity are calculated. The total time for this questionnaire is 1 minute. The Godin Leisure Time Questionnaire has been validated to assess physical activity. | Change from baseline self-reported physical activity at 6 months (ACL tear participants) |
| Change in Self-Reported Physical Activity over 12 months (ACL tear participants) | The 4 item Godin Leisure Time Questionnaire will be used to measure self-reported physical activity. Using the number of 15-minute bouts of mild, moderate, and strenuous physical activity a participant engages in over a typical seven-day period weekly metabolic equivalents of physical activity are calculated. The total time for this questionnaire is 1 minute. The Godin Leisure Time Questionnaire has been validated to assess physical activity. | Change from baseline self-reported physical activity at 12 months (ACL tear participants) |
| Change in Self-Reported Physical Activity over 24 months (ACL tear participants) | The 4 item Godin Leisure Time Questionnaire will be used to measure self-reported physical activity. Using the number of 15-minute bouts of mild, moderate, and strenuous physical activity a participant engages in over a typical seven-day period weekly metabolic equivalents of physical activity are calculated. The total time for this questionnaire is 1 minute. The Godin Leisure Time Questionnaire has been validated to assess physical activity. | Change from baseline self-reported physical activity at 24 months (ACL tear participants) |
| Change in Health-Related Quality of Life over 6 months (ACL tear participants) | The EQ-5D-5L is a simple, reliable self-report instrument designed to assess generic health for clinical and economic appraisal across multiple countries and conditions (see attachment 16-EQ-5D-5L). The EQ-5D-5L provides information about 5 levels of problems across 5 health domains (anxiety/depression, pain/discomfort, mobility, self-care, usual activities), and a 0-to-100 visual analogue scale rating for self-related health (EQ-5D-5Lindex). EQ-5D-5Lindex values will be reported at each time point. | Change from baseline health-related quality of life at 6 months (ACL tear participants) |
| Change in Health-Related Quality of Life over 12 months (ACL tear participants) | The EQ-5D-5L is a simple, reliable self-report instrument designed to assess generic health for clinical and economic appraisal across multiple countries and conditions (see attachment 16-EQ-5D-5L). The EQ-5D-5L provides information about 5 levels of problems across 5 health domains (anxiety/depression, pain/discomfort, mobility, self-care, usual activities), and a 0-to-100 visual analogue scale rating for self-related health (EQ-5D-5Lindex). EQ-5D-5Lindex values will be reported at each time point. | Change from baseline health-related quality of life at 12 months (ACL tear participants) |
| Change in Health-Related Quality of Life over 24 months (ACL tear participants) | The EQ-5D-5L is a simple, reliable self-report instrument designed to assess generic health for clinical and economic appraisal across multiple countries and conditions (see attachment 16-EQ-5D-5L). The EQ-5D-5L provides information about 5 levels of problems across 5 health domains (anxiety/depression, pain/discomfort, mobility, self-care, usual activities), and a 0-to-100 visual analogue scale rating for self-related health (EQ-5D-5Lindex). EQ-5D-5Lindex values will be reported at each time point. | Change from baseline health-related quality of life at 24 months (ACL tear participants) |
| Change in Fat Mass Index over 6 months (ACL tear participants) | Fat mass index (kg/m2) will be measured with Bioelectrical Impedance (Tanita Body Composition Analyzer, Model TBF-300A, Tanita Inc., USA). Participants will stand barefoot on the bioelectrical impedance platform during which the resistance to the flow of this single, high frequency alternating electrical current (500 A at 50 kHz) will be measured. Bioelectrical Impedance is a feasible method for assessing and tracking body composition in clinical settings and has been shown to be valid and reliable in child, youth, and adult populations. This test will take 5 minutes to complete. The device will be calibrated prior to each scan (according to the manufacturer's protocol). | Change from baseline fat mass index at 6 months (ACL tear participants) |
| Change in Fat Mass Index over 12 months (ACL tear participants) | Fat mass index (kg/m2) will be measured with Bioelectrical Impedance (Tanita Body Composition Analyzer, Model TBF-300A, Tanita Inc., USA). Participants will stand barefoot on the bioelectrical impedance platform during which the resistance to the flow of this single, high frequency alternating electrical current (500 A at 50 kHz) will be measured. Bioelectrical Impedance is a feasible method for assessing and tracking body composition in clinical settings and has been shown to be valid and reliable in child, youth, and adult populations. This test will take 5 minutes to complete. The device will be calibrated prior to each scan (according to the manufacturer's protocol). | Change from baseline fat mass index at 12 months (ACL tear participants) |
| Change in Fat Mass Index over 24 months (ACL tear participants) | Fat mass index (kg/m2) will be measured with Bioelectrical Impedance (Tanita Body Composition Analyzer, Model TBF-300A, Tanita Inc., USA). Participants will stand barefoot on the bioelectrical impedance platform during which the resistance to the flow of this single, high frequency alternating electrical current (500 A at 50 kHz) will be measured. Bioelectrical Impedance is a feasible method for assessing and tracking body composition in clinical settings and has been shown to be valid and reliable in child, youth, and adult populations. This test will take 5 minutes to complete. The device will be calibrated prior to each scan (according to the manufacturer's protocol). | Change from baseline fat mass index at 24 months (ACL tear participants) |
| Change in Knee Cartilage Health over 24 months (ACL tear participants) | Preliminary research links exercise-therapy to better knee cartilage health in people at risk of post-traumatic OA (post-meniscectomy) and early atraumatic OA up to 12-months. We will provide further insight over 24-months by quantifying changes in cartilage T2 relaxation times (sagittal multi-echo-spin-echo pulse sequences;12 echos) which are widely used as a marker of early degeneration. An senior imaging scientist will segment the cartilage manually and calculate average T2 for femoral, tibial and patellar cartilage plates. | Change from baseline knee cartilage health at 24 months (ACL tear participants) |
| Sea to Sky Orthopaedics | Recruiting | Whistler | British Columbia | V8E 1A6 | Canada |
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| Background |
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| 40542399 | Derived | Whittaker JL, Cammalleri A, Archibald C, Brooks-Hill A, Chin P, Clark S, Davis JC, Hoens AM, Hunt MA, Kausky K, Ko A, Leveille L, Li LC, Lodhia P, Losciale JM, Miciak M, Mosewich AD, Sheikh A, Silvester-Lee T, Truong LK, Wade D, Wilson DR, Xie H, Yan XH, Roos EM. Digital education and exercise therapy versus minimal intervention for young people at high risk of early onset knee osteoarthritis after ACL reconstruction: a study protocol for the Stop OsteoARthritis (SOAR) randomized controlled trial. Trials. 2025 Jun 20;26(1):213. doi: 10.1186/s13063-025-08896-6. |
| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001519 | Behavior |