ArthritisSOARPOCNCT04956393
The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study
A study testing Immediate 8-Week SOAR Program and Delayed 8-Week SOAR Program in people with Arthritis and Osteoarthritis, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Osteoarthritis, Arthritis Knee
- What is being tested?
- Immediate 8-Week SOAR Program and Delayed 8-Week SOAR Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Knee Injury Participant Inclusion Criteria:
- 16-35 years of age
- Currently live in British Columbia, Canada
- Experienced a sport-related intra-articular knee injury (i.e., clinical diagnosis of ligament, meniscal, or other intra-articular tibio- or patello-femoral trauma) that required both medical consultation (i.e., physician, physiotherapist, chiropractor, surgeon, or athletic therapist) and disrupted regular sports participation (missed at least one training session or competition) 12-36 months previously.18
- Are currently not receiving ongoing health care related to the past knee injury and have no scheduled surgical procedures (any part of the body) that would interfere with exercise during the study.
- Have daily access to an email address and a computer with internet
Show all 11Show fewer
- Are willing to wear an activity tracker during the study
- Physiotherapist Participant Inclusion Criteria:
- Registered physiotherapist
- Able to communicate in English
- Have an email address and daily access to a computer with internet service
Who cannot join
- Knee Injury Participant Exclusion Criteria:
- Inability to communicate in English
- Previous physician diagnosis of index knee osteoarthritis
- Inflammatory arthritis or systemic condition
- Lower limb injury, surgery, or intra-articular injection in the past 6-months
- Current pregnancy
Show all 11Show fewer
- Have a pacemaker or other internal medical device
- Physiotherapist Participant Exclusion Criteria:
- Do not hold a license to practice physiotherapy
- Unable to communicate in English
- Do not have an email address or daily access to a computer with internet service
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Proof-of-Concept of the SOAR (Stop OsteoARthritis) Program: A Randomized Delayed-Control Trial
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.
Read the 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:
- 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.
- 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.
- A third objective of this study is to inform the optimal length of the SOAR program.
- 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.
- Conditions
- Arthritis, Osteoarthritis, Arthritis Knee, Osteo Arthritis Knee, Knee Injuries, Anterior Cruciate Ligament Tear
- Being tested
- Immediate 8-Week SOAR Program, Delayed 8-Week SOAR Program
- Keywords
- Randomized delayed control trial, Knee health, Knee injury, Sport injury, Knee muscle, Self-efficacy, Quality of life, Osteoarthritis
- Medical subject headings
- Arthritis, Osteoarthritis, Knee Injuries, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate 8-Week SOAR ProgramBehavioural
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.
Delayed 8-Week SOAR ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate SOAR Program | Experimental | Participants with a past sport-related knee injury randomized to the 'immediate intervention' group will complete an 8-week (weeks 1-8) SOAR program (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 physiotherapist 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. Consented trained physiotherapists will deliver the SOAR program throughout the study period to one or more immediate SOAR group knee injury participants. Receives: Behavioral: Immediate 8-Week SOAR Program |
| Delayed SOAR Program | Other | Participants with a past sport-related knee injury randomized to the 'delayed intervention' group will have a 9-week unstandardized delay before completing an 8-week SOAR program (weeks 10-17). During the delay (weeks 1-9) the delay comparison intervention will be unstandardized to reflect usual care in Canada. After the 9-week delay, these participants will complete an 8-week (weeks 10-17) SOAR program (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT counseling sessions, and an optional weekly group-based exercise classes). Consented trained physiotherapists will deliver the SOAR program from week 10 to week 17 to one or more delayed SOAR group knee injury participants. Receives: Behavioral: Delayed 8-Week SOAR Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Extensor Strength over 9-weeks (knee injury participants)
A computerized dynamometer (Biodex®) will be used to assess and calculate normalized peak concentric knee extension (quadriceps muscle) isokinetic torque (Nm/kg) at 90 degrees/seconds over 0-100 degrees of knee flexion. After a five-minute stationary cycling warm-up, participants will be seated with straps secured across their hips and chest. After three practice trials and a 30-second rest, participants will be instructed to straighten and bend their knee as hard as they can for three repetitions. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle strength.
Measured: Change from baseline knee extensor muscle strength at 9-weeks
Secondary outcomes (3)
Change in Daily Average Moderate to Vigorous Physical Activity over 9-weeks (knee injury 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.
Measured: Change from baseline daily average moderate to vigorous physical activity at 9-weeks
Change in Self-reported Knee-specific Self-Efficacy over 9-weeks (knee injury participants)
A 19 item questionnaire (the Knee Self-efficacy Scale) will be used to measure self-reported knee-specific self-efficacy. Each item is scored on an 0-10-point Likert scale, with 0 indicating no knee-related self-efficacy and 10 indicating full knee-related self-efficacy. Individual item scores are summed and divided by 19 to produce a total score ranging from 0-10 (0 representing poor knee-related self-efficacy and 10 representing full knee-related self-efficacy). The total time for this questionnaire is 3 minutes. The Knee Self-efficacy Scale is a valid and reliable measure of knee-specific self-efficacy in individuals with a sport-related knee injury in the past five years.
Measured: Change from baseline knee-specific self-efficacy at 9-weeks
Change in Self-reported Knee-related Quality of Life over 9-weeks (knee injury participants)
A 5 item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used to measure self-reported knee-related quality of life. Each item is scored on an 0-10-point Likert scale, with 0 indicating no knee-related quality of life and 10 indicating full knee-related quality of life. Individual item scores are summed and transformed to a score out of 100 (0 representing poor knee-related quality of life and 100 representing full knee-related quality of life). The total time for this questionnaire is 3 minutes. The KOOS knee-related quality of life sub-scale is a valid and reliable patient-reported outcome measure across multiple patient populations, including at various timepoints after knee trauma
Measured: Change from baseline knee-related quality of life at 9-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Sep 2021
- Primary completion28 Feb 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (80)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- The Arthritis Society, Canada, Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research
- Responsible party
- Principal investigator, Jackie Whittaker, University of British Columbia
- Investigators
- Jackie L Whittaker, PhD, PT, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956393
- Sponsor's protocol ID
- REB# H21-01491
- Acronym
- SOARPOC
- Status last verified
- Dec 2023
- First submitted
- 23 Jun 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, Collins G, Kaufman J, Qorbani M, Moradi-Lakeh M, Woolf AD, Guillemin F, March L, Cross M. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020 Jun;79(6):819-828. doi: 10.1136/annrheumdis-2019-216515. Epub 2020 May 12.
PubMed 32398285March LM, Bachmeier CJ. Economics of osteoarthritis: a global perspective. Baillieres Clin Rheumatol. 1997 Nov;11(4):817-34. doi: 10.1016/s0950-3579(97)80011-8.
PubMed 9429738Yu D, Jordan KP, Bedson J, Englund M, Blyth F, Turkiewicz A, Prieto-Alhambra D, Peat G. Population trends in the incidence and initial management of osteoarthritis: age-period-cohort analysis of the Clinical Practice Research Datalink, 1992-2013. Rheumatology (Oxford). 2017 Nov 1;56(11):1902-1917. doi: 10.1093/rheumatology/kex270.
PubMed 28977564Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.
PubMed 26439406Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
PubMed 31278997Snoeker B, Turkiewicz A, Magnusson K, Frobell R, Yu D, Peat G, Englund M. Risk of knee osteoarthritis after different types of knee injuries in young adults: a population-based cohort study. Br J Sports Med. 2020 Jun;54(12):725-730. doi: 10.1136/bjsports-2019-100959. Epub 2019 Dec 11.
PubMed 31826861Fernandes GS, Parekh SM, Moses J, Fuller C, Scammell B, Batt ME, Zhang W, Doherty M. Prevalence of knee pain, radiographic osteoarthritis and arthroplasty in retired professional footballers compared with men in the general population: a cross-sectional study. Br J Sports Med. 2018 May;52(10):678-683. doi: 10.1136/bjsports-2017-097503. Epub 2017 Nov 3.
PubMed 29101102Gianotti SM, Marshall SW, Hume PA, Bunt L. Incidence of anterior cruciate ligament injury and other knee ligament injuries: a national population-based study. J Sci Med Sport. 2009 Nov;12(6):622-7. doi: 10.1016/j.jsams.2008.07.005. Epub 2008 Oct 2.
PubMed 18835221Emery C, Tyreman H. Sport participation, sport injury, risk factors and sport safety practices in Calgary and area junior high schools. Paediatr Child Health. 2009 Sep;14(7):439-44. doi: 10.1093/pch/14.7.439.
PubMed 20808471Watt FE, Corp N, Kingsbury SR, Frobell R, Englund M, Felson DT, Levesque M, Majumdar S, Wilson C, Beard DJ, Lohmander LS, Kraus VB, Roemer F, Conaghan PG, Mason DJ; Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working Group. Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury. Osteoarthritis Cartilage. 2019 Jan;27(1):23-33. doi: 10.1016/j.joca.2018.08.001. Epub 2018 Aug 18.
PubMed 30125638Toomey CM, Whittaker JL, Nettel-Aguirre A, Reimer RA, Woodhouse LJ, Ghali B, Doyle-Baker PK, Emery CA. Higher Fat Mass Is Associated With a History of Knee Injury in Youth Sport. J Orthop Sports Phys Ther. 2017 Feb;47(2):80-87. doi: 10.2519/jospt.2017.7101.
PubMed 28142363Whittaker JL, Toomey CM, Nettel-Aguirre A, Jaremko JL, Doyle-Baker PK, Woodhouse LJ, Emery CA. Health-related Outcomes after a Youth Sport-related Knee Injury. Med Sci Sports Exerc. 2019 Feb;51(2):255-263. doi: 10.1249/MSS.0000000000001787.
PubMed 30239493Whittaker JL, Toomey CM, Woodhouse LJ, Jaremko JL, Nettel-Aguirre A, Emery CA. Association between MRI-defined osteoarthritis, pain, function and strength 3-10 years following knee joint injury in youth sport. Br J Sports Med. 2018 Jul;52(14):934-939. doi: 10.1136/bjsports-2017-097576. Epub 2017 Oct 10.
PubMed 29018061Whittaker JL, Woodhouse LJ, Nettel-Aguirre A, Emery CA. Outcomes associated with early post-traumatic osteoarthritis and other negative health consequences 3-10 years following knee joint injury in youth sport. Osteoarthritis Cartilage. 2015 Jul;23(7):1122-9. doi: 10.1016/j.joca.2015.02.021. Epub 2015 Feb 26.
PubMed 25725392Baltich J, Whittaker J, Von Tscharner V, Nettel-Aguirre A, Nigg BM, Emery C. The impact of previous knee injury on force plate and field-based measures of balance. Clin Biomech (Bristol). 2015 Oct;30(8):832-8. doi: 10.1016/j.clinbiomech.2015.06.005. Epub 2015 Jun 12.
PubMed 26094135
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept of the SOAR (Stop OsteoARthritis) Program: A Randomized Delayed-Control Trial
- ClinicalTrials.gov ID
- NCT04956393
- Acronym / sponsor ID
- SOARPOC / REB# H21-01491
- Conditions
- Arthritis, Osteoarthritis, Arthritis Knee, Osteo Arthritis Knee, Knee Injuries, Anterior Cruciate Ligament Tear
- Keywords
- Randomized delayed control trial, Knee health, Knee injury, Sport injury, Knee muscle, Self-efficacy, Quality of life, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- The Arthritis Society, Canada, Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- A third objective of this study is to inform the optimal length of the SOAR program.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate SOAR Program | Experimental | Behavioral: Immediate 8-Week SOAR ProgramParticipants with a past sport-related knee injury randomized to the 'immediate intervention' group will complete an 8-week (weeks 1-8) SOAR program (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 physiotherapist 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. Consented trained physiotherapists will deliver the SOAR program throughout the study period to one or more immediate SOAR group knee injury participants. |
| Delayed SOAR Program | Other | Behavioral: Delayed 8-Week SOAR ProgramParticipants with a past sport-related knee injury randomized to the 'delayed intervention' group will have a 9-week unstandardized delay before completing an 8-week SOAR program (weeks 10-17). During the delay (weeks 1-9) the delay comparison intervention will be unstandardized to reflect usual care in Canada. After the 9-week delay, these participants will complete an 8-week (weeks 10-17) SOAR program (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT counseling sessions, and an optional weekly group-based exercise classes). Consented trained physiotherapists will deliver the SOAR program from week 10 to week 17 to one or more delayed SOAR group knee injury participants. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 16-35 years of age
- Currently live in British Columbia, Canada
- Experienced a sport-related intra-articular knee injury (i.e., clinical diagnosis of ligament, meniscal, or other intra-articular tibio- or patello-femoral trauma) that required both medical consultation (i.e., physician, physiotherapist, chiropractor, surgeon, or athletic therapist) and disrupted regular sports participation (missed at least one training session or competition) 12-36 months previously.18
- Are currently not receiving ongoing health care related to the past knee injury and have no scheduled surgical procedures (any part of the body) that would interfere with exercise during the study.
- Have daily access to an email address and a computer with internet
Key exclusion criteria (11 listed)
- Inability to communicate in English
- Previous physician diagnosis of index knee osteoarthritis
- Inflammatory arthritis or systemic condition
- Lower limb injury, surgery, or intra-articular injection in the past 6-months
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate 8-Week SOAR ProgramThis is an 8-week, virtually delivered, exercise-based, knee health program delivered to knee injury participants by trained physiotherapists. The program has 3 components: 1. 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. 2. 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. 3. 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. | Behavioural | Immediate SOAR Program |
| Delayed 8-Week SOAR ProgramThis is an 8-week, virtually delivered, exercise-based, knee health program delivered to knee injury participants by trained physiotherapists. The program has 3 components: 1. 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. 2. 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. 3. 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. | Behavioural | Delayed SOAR Program |
Primary outcome
Change in Knee Extensor Strength over 9-weeks (knee injury participants)
Time frame: Change from baseline knee extensor muscle strength at 9-weeks
A computerized dynamometer (Biodex®) will be used to assess and calculate normalized peak concentric knee extension (quadriceps muscle) isokinetic torque (Nm/kg) at 90 degrees/seconds over 0-100 degrees of knee flexion. After a five-minute stationary cycling warm-up, participants will be seated with straps secured across their hips and chest. After three practice trials and a 30-second rest, participants will be instructed to straighten and bend their knee as hard as they can for three repetitions. The total time for this test is 10 minutes. Computerized dynamometry (Biodex®) is a reliable, valid, relevant, and recommended measure of muscle strength.
3 secondary outcomes
Change in Daily Average Moderate to Vigorous Physical Activity over 9-weeks (knee injury participants)
Time frame: Change from baseline daily average moderate to vigorous physical activity at 9-weeks
Change in Self-reported Knee-specific Self-Efficacy over 9-weeks (knee injury participants)
Time frame: Change from baseline knee-specific self-efficacy at 9-weeks
Change in Self-reported Knee-related Quality of Life over 9-weeks (knee injury participants)
Time frame: Change from baseline knee-related quality of life at 9-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Background: PubMed 32398285Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, Collins G, Kaufman J, Qorbani M, Moradi-Lakeh M, Woolf AD, Guillemin F, March L, Cross M. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020 Jun;79(6):819-828. doi: 10.1136/annrheumdis-2019-216515. Epub 2020 May 12.
- Background: PubMed 9429738March LM, Bachmeier CJ. Economics of osteoarthritis: a global perspective. Baillieres Clin Rheumatol. 1997 Nov;11(4):817-34. doi: 10.1016/s0950-3579(97)80011-8.
- Background: PubMed 28977564Yu D, Jordan KP, Bedson J, Englund M, Blyth F, Turkiewicz A, Prieto-Alhambra D, Peat G. Population trends in the incidence and initial management of osteoarthritis: age-period-cohort analysis of the Clinical Practice Research Datalink, 1992-2013. Rheumatology (Oxford). 2017 Nov 1;56(11):1902-1917. doi: 10.1093/rheumatology/kex270.
- Background: PubMed 26439406Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.
- Background: PubMed 31278997Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Background: PubMed 31826861Snoeker B, Turkiewicz A, Magnusson K, Frobell R, Yu D, Peat G, Englund M. Risk of knee osteoarthritis after different types of knee injuries in young adults: a population-based cohort study. Br J Sports Med. 2020 Jun;54(12):725-730. doi: 10.1136/bjsports-2019-100959. Epub 2019 Dec 11.
- Background: PubMed 29101102Fernandes GS, Parekh SM, Moses J, Fuller C, Scammell B, Batt ME, Zhang W, Doherty M. Prevalence of knee pain, radiographic osteoarthritis and arthroplasty in retired professional footballers compared with men in the general population: a cross-sectional study. Br J Sports Med. 2018 May;52(10):678-683. doi: 10.1136/bjsports-2017-097503. Epub 2017 Nov 3.
- Background: PubMed 18835221Gianotti SM, Marshall SW, Hume PA, Bunt L. Incidence of anterior cruciate ligament injury and other knee ligament injuries: a national population-based study. J Sci Med Sport. 2009 Nov;12(6):622-7. doi: 10.1016/j.jsams.2008.07.005. Epub 2008 Oct 2.
- Background: PubMed 20808471Emery C, Tyreman H. Sport participation, sport injury, risk factors and sport safety practices in Calgary and area junior high schools. Paediatr Child Health. 2009 Sep;14(7):439-44. doi: 10.1093/pch/14.7.439.
- Background: PubMed 30125638Watt FE, Corp N, Kingsbury SR, Frobell R, Englund M, Felson DT, Levesque M, Majumdar S, Wilson C, Beard DJ, Lohmander LS, Kraus VB, Roemer F, Conaghan PG, Mason DJ; Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working Group. Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury. Osteoarthritis Cartilage. 2019 Jan;27(1):23-33. doi: 10.1016/j.joca.2018.08.001. Epub 2018 Aug 18.
- Background: PubMed 28142363Toomey CM, Whittaker JL, Nettel-Aguirre A, Reimer RA, Woodhouse LJ, Ghali B, Doyle-Baker PK, Emery CA. Higher Fat Mass Is Associated With a History of Knee Injury in Youth Sport. J Orthop Sports Phys Ther. 2017 Feb;47(2):80-87. doi: 10.2519/jospt.2017.7101.
- Background: PubMed 30239493Whittaker JL, Toomey CM, Nettel-Aguirre A, Jaremko JL, Doyle-Baker PK, Woodhouse LJ, Emery CA. Health-related Outcomes after a Youth Sport-related Knee Injury. Med Sci Sports Exerc. 2019 Feb;51(2):255-263. doi: 10.1249/MSS.0000000000001787.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie L Whittaker, PhD, PT principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate 8-Week SOAR Program and Delayed 8-Week SOAR Program in people with Arthritis and Osteoarthritis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Extensor Strength over 9-weeks (knee injury participants) (time frame: Change from baseline knee extensor muscle strength at 9-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956393, which also lists 80 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.