The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study

NCT ID: NCT04956393

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-04-15

Brief Summary

Adolescents and young adults who hurt their knees playing sports or doing recreational activities can develop joint damage, muscle weakness, inactivity, and weight gain which might lead to an increased risk of osteoarthritis (OA), a disabling joint condition in their later lives. Despite knowing that muscles and joints benefit from exercise, there is no proven exercise-based treatments to delay or even halt the onset of OA after a knee joint injury.

The current study will assess if a physiotherapist-guided intervention called Stop OsteoARthritis (SOAR) improves knee muscle strength, physical inactivity, knee-related self-efficacy, and knee-related quality of life in people at risk for osteoarthritis due to a past knee injury. A total of 70 former knee injury participants will be randomly assigned to two groups. One group will immediately start a 16-week SOAR program, while the second will wait for 9-weeks before starting an 8-week SOAR program. Trained physiotherapists will deliver the SOAR program with videoconferencing. The study hypothesis is that participating in the 8-Week SOAR program will improve the knee muscle strength, physical activity levels, knee-related self-efficacy and knee-related quality of life in people discharged from regular healthcare after a sports knee injury. The findings will help researchers understand the ideal length of the program for a future clinical trial in real-world settings.

Detailed Description

Purpose:

The purpose of this study is to evaluate a novel, virtually delivered, PT-guided, knee health program (Stop OsteoARthritis - SOAR) for people who have been discharged from regular healthcare after a sports knee injury.

Objectives:

1. The primary objective of the study is to assess the efficacy of an 8-week SOAR program to improve knee muscle strength measured by computerized dynamometry (primary outcome and daily average moderate to vigorous physical activity measured by Tri-axial Accelerometer (secondary outcome), self-reported knee-specific self-efficacy (secondary outcome), and self-reported knee-related quality of life (secondary outcome) in people discharged from regular care after sports knee trauma. Several exploratory outcomes will also be assessed to inform the design of a future clinical trial.

2. A secondary objective of this study is to evaluate the feasibility of a protocol for a future full-scale clinical trial to assess the effectiveness and implementation of SOAR. Both SOAR program and study protocol implementation and practicality outcomes will be collected.

3. A third objective of this study is to inform the optimal length of the SOAR program.

4. A fourth, exploratory objective, of this study, is to explore the experiences of stakeholders (i.e., knee injury participants and physiotherapists) to inform future implementation.

Research Design:

This is a proof-of-concept, two-armed, open-label, randomized delayed control trial with embedded 1:1 interviews. In this design, randomization determines when the intervention is provided (immediate or 9-week delay). Consenting eligible knee injury participants will be randomly allocated in a 1:1 ratio to immediate intervention (experimental) or delayed intervention (control) groups using a computer-generated sequence of random numbers. Consenting eligible and physiotherapists will complete Brief Action Planning certification and SOAR training before delivering the SOAR program virtually to the knee injury participants.

The immediate study group will be complete an 8-week (weeks 1-8) SOAR program (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT counseling sessions, and optional weekly group-based exercise classes) followed by an additional 8 weeks (weeks 10-17) of home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT counseling sessions, and optional weekly group-based exercise classes. In contrast, after a 9-week delay, the delayed study group will complete an 8-week (weeks 10-17) intervention (Knee Camp, home-based exercise-therapy and physical activity with tracking, weekly 1:1 PT counseling sessions, and optional weekly group-based exercise classes).

Knee injury participant outcomes will be evaluated at baseline (T0), 9-weeks (T1-primary endpoint to assess efficacy), and 18-weeks (T2- endpoint to inform optimal intervention length).

Physiotherapist participants will be evaluated prior to training, immediately after training, and after they have delivered the SOAR program to all knee injury participants that they have been assigned in the study.

Statistical Analysis:

Descriptive statistics will be calculated for all demographic variables, and observed differences (sex, prior injury, injury type, prior treatment, etc.) considered when interpreting findings. Randomization integrity will be monitored. Outcomes will be disaggregated by sex and gender, and mean differences between T0 and T1, and T1 and T2 described by the study group. Intention-to-treat analyses will be conducted. Generalized linear mixed-effects regression models for longitudinal data (95%CI), controlling for the blocking effect, will estimate the effect of an 8-week intervention (IG T1-T0 versus DG T1-T0, and DG T2-T1 versus T1-T0) and the delay (IG T1-T0 versus DG T2-T1) for the primary outcome (Figure 2).

In addition, two exploratory analyses will be conducted. To inform the optimal intervention length for the future clinical trial, a longitudinal mixed-effects model will be used to examine the intervention effect at 16-week. This model will include the following fixed effects: 1) the randomization group indicator for baseline difference; 2) indicator variables for follow-up assessment time points (9-week and 18-week) to account for secular trend, and; 3) indicator variables for the lengths of time since intervention initiation (9-week or 18-week) to estimate effects after these time intervals. The model will also include participant-specific random effects to account for repeated measures. To inform the most meaningful muscle function outcome for the future clinical trial linear regression (95%CI) models, adjusted for age and sex, will be used to identify differences in the association between various aspects of knee extensor muscle function (torque, power, rate of force development), and composite self-reported knee symptoms and function score.

Interview recordings with knee injury participants and physiotherapist participants will be transcribed verbatim and de-identified. Using a constant comparative approach data will be coded and categories developed by comparing and determining meaningful patterns across codes. High-order themes will illuminate the relationship between categories. Uniqueness in experience by gender will be explored and if identified, data will be reanalyzed in gender sub-groups. A detailed audit of analytic decisions will be kept.

Conditions

Arthritis; Osteoarthritis; Arthritis Knee; Osteo Arthritis Knee; Knee Injuries; Anterior Cruciate Ligament Tear; Meniscus Tear

Keywords

Randomized delayed control trial; Knee health; Knee injury; Sport injury; Knee muscle; Self-efficacy; Quality of life; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate SOAR Program

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.

Group Type: EXPERIMENTAL

Immediate 8-Week SOAR Program

Intervention Type: BEHAVIORAL

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:

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.

Delayed SOAR Program

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.

Group Type: OTHER

Delayed 8-Week SOAR Program

Intervention Type: BEHAVIORAL

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:

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.

Interventions

Immediate 8-Week SOAR Program

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:

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.

Intervention Type: BEHAVIORAL

Delayed 8-Week SOAR Program

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:

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 16-35 years of age

2. Currently live in British Columbia, Canada

3. 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

4. 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.

5. Have daily access to an email address and a computer with internet

6. Are willing to wear an activity tracker during the study

1. Registered physiotherapist

2. Able to communicate in English

3. Have an email address and daily access to a computer with internet service

Exclusion Criteria

1. Inability to communicate in English

2. Previous physician diagnosis of index knee osteoarthritis

3. Inflammatory arthritis or systemic condition

4. Lower limb injury, surgery, or intra-articular injection in the past 6-months

5. Current pregnancy

6. Have a pacemaker or other internal medical device

1. Do not hold a license to practice physiotherapy

2. Unable to communicate in English

3. Do not have an email address or daily access to a computer with internet service

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Arthritis Society, Canada

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Michael Smith Foundation for Health Research

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jackie Whittaker

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jackie L Whittaker, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

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Related Links

http://ktpathways.ca/resources/kt-planning-template

Barwick M. Knowledge Translation Planning Template. In. Ontario: The Hospital for Sick Children; 2013

Other Identifiers

REB# H21-01491

Identifier Type: -

Identifier Source: org_study_id