Preventing Knee Osteoarthritis Through Exercise and Education Following Knee Injury

Study Overview
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Brief Summary
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This study evaluates the preliminary efficacy of an 8-week exercise and education intervention on musculoskeletal health of young adults with a previous sport-related knee injury that are at high risk of post-traumatic osteoarthritis. In addition, the purpose of this pilot randomized controlled trial is to determine the feasibility of the study methods and procedures to inform the design of a future randomized controlled trial.

Detailed Description
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PURPOSE The purpose of this study is to determine the preliminary efficacy of an 8-week exercise and education intervention on musculoskeletal health of young adults with a previous sport-related knee injury that are at high risk of post-traumatic osteoarthritis. In addition, the purpose is to determine the feasibility of the study methods and procedures. In addition, the longitudinal changes in health-related factors in participants who are recruited from a previous cohort study will be described, as well as the estimated cost of healthcare utilization during one year in a population of young adults with history of sport-related knee injury. METHODS Study design and participants This is a pilot randomized controlled trial stepped-wedge design. Participants will include 40 men and women, age 21 to 33 years, who sustained a physician-confirmed youth (≤ 18 years of age) sport-related intra-articular knee injury 5 to 16 years ago. Participants will be randomly assigned to the intervention group (n=20) or the control group (n=20) in permuted blocks of varying size and stratified during randomization by sex. To ensure allocation concealment, the trial biostatistician, who is not involved in participant recruitment or baseline testing, will generate the randomization sequence. After the participant has been tested at baseline, the study physiotherapist will open the envelope and informed the participant about allocation to intervention or control group. If a participant expresses that they are unable to participate in the group they were allocated to, they will not be excluded from this pilot study. Instead, they are permitted to participate in the group that is suitable to them. The number of these cases will be recorded and reported. All participants will undergo baseline testing at the same time. Intervention group will then complete the 8-week intervention, while the control group will not begin the intervention until 8 weeks after their baseline measurements. Intervention group will complete a 16-week maintenance period while control group will complete eight weeks of maintenance. All participants will undergo functional (i.e. balance and strength) tests, body composition measurements, 7-day physical activity monitoring and fill self-report tools (i.e. Knee Injury and Osteoarthritis Outcome Score, knee self-efficacy) at four time points: baseline, 8-weeks, 16-weeks and 24-weeks. Experimental Intervention: the SHRED Osteoarthritis program Exercise Component: Previous research on the effects of neuromuscular training after knee injuries and on patients with knee OA, research on neuromuscular control, exercise training principles and the research group's clinical experience were considered when designing the exercise component of the SHRED Osteoarthritis program. The SHRED Osteoarthritis program consists of an an 8-minute warm-up, 42-minute circuit training through seven exercise stations, 5 minutes of specialized skill and control exercises and 5-minute cool down inclusive of flexibility exercises. The SHRED Osteoarthritis program will be delivered through two 60-minute group exercise classes per week for 8 weeks (16 classes). In addition, participants will complete a 30-minute home exercise session once a week (8 sessions). The SHRED Osteoarthritis exercise classes will be lead by a study physiotherapist assisted by kinesiologists, kinesiology students or physiotherapy students with a supervision rate of one instructor for every four participants. The 30-minute home exercise sessions will consist of a warm-up (8 min) and four exercises from the SHRED Osteoarthritis program. The physiotherapist leading the SHRED Osteoarthritis classes will assign specific exercises to each participant, based on individual needs and the program will be revised weekly. Education Component: Patient education is embedded into the 16, one-hour supervised group exercise classes. Education components will include the causes and course of knee pain, identification of a flare-up, management and first aid for self-management of knee pain or flare-ups, appropriate imaging, exercise progression and treatment options (conservative vs. surgical). This content was built from clinical practice guidelines, expert recommendations, patient interviews and theoretical frameworks that outline patient needs, modifiable risk factors, proposed change objects and performance objectives. Maintenance Component: After the 8-week intervention has been completed, participants will enter a maintenance stage. During this time (16 weeks for intervention group, 8 weeks for control group), the participants will be asked to complete an individualized home exercise program twice a week. During the maintenance period, participants have the opportunity to contact the study physiotherapist via phone or email to discuss their progression and possible changes to their program. In addition, drop-in times will be available twice a week. During these times, participants can come to discuss their program with the study physiotherapist.

Official Title
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Preventing Post-traumatic Osteoarthritis and Other Health Consequences Following Knee Joint Injury: A Pilot Randomized Controlled Trial

Conditions
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Osteoarthritis Knees Both Post-Traumatic

Intervention / Treatment
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* Other: SHRED Osteoarthritis program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sustained a physician-confirmed intra-articular sport-related knee injury in age 18 years or younger Exclusion Criteria: Injury or a flare-up at the time of recruitment, which makes the individual unable to participate in more than two exercises in the exercise program Pregnancy Any contraindication to exercise Lower extremity surgery within the last 6 months Already attending structured supervised exercise or other treatment to improve knee function Not available to participate in the weekly exercise classes

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Step-wedge design with two parallel arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>8-week exercise and education intervention. Two 60-minute physiotherapist-lead group exercise classes with education incorporated will be delivered weekly for 8 weeks (16 classes). In addition, participants will complete a 30-minute home exercise session once a week for 8-weeks (8 sessions). After the intervention, the group will enter a 16-week maintenance stage. During maintenance, a 30-minute home exercise program is completed twice a week. | Other: SHRED Osteoarthritis program<br>* Combined exercise and education intervention<br>|
| Other: Control<br>The control group will not receive an intervention during the first 8-weeks of the study. Being a step-wedge design, this group will receive the same 8-week exercise and education intervention later, after the intervention group has completed the intervention and the post-intervention testing. After the control group has completed the 8-week intervention, they will enter an 8-week maintenance stage. During maintenance, a 30-minute home exercise program is completed twice a week. | Other: SHRED Osteoarthritis program<br>* Combined exercise and education intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Extension Strength | Normalized knee extension strength will be assessed using hand-held isometric dynamometry. The peak isometric strength (N) from the three trials will be recorded for both legs. The peak isometric strength scores are converted to torque values (Nm; force x distance between joint line and dynamometer position) and normalized to body weight (Nm/kg). The mean value of the three trials will be calculated. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Participation Rate | Attendance in the group exercise classes and completion of the home exercise sessions will be recorded. Participation rate for the two study groups (intervention/control) will be calculated as the proportion of completed group exercise classes and home exercise sessions out of the total possible group exercise classes and home exercise sessions over the 8-week intervention. | Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate | Retention rate will be described as the proportion of randomized participants retained the end of the study out of the total number of randomized participants. | The duration of the study (weeks 1-24), will be calculated in the end. | 
| Joint-Specific Adverse Events | The number of joint-specific adverse events will be recorded. Joint-specific adverse events are determined as participant not attending an exercise session and/or ceasing participation due to increased pain or problems in the index knee and self-reported pain greater than 5 on a scale of 0 to 10 scale after an exercise session. | The duration of the study (weeks 1-24) | 
| Self-reported Pain Before and After Exercise | Self-reported pain will be measured on a scale of 0 to 10. Pain will be monitored before class, in the end of the class, and 24 hours after class. Participants will record the pain score in their individual training diary before and after class. To record pain score 24 hours after class, a text message or an email (depending on participant's preference) containing a link to record the pain score will be sent using research electronic data capture (REDCap) software. | Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group. | 
| Major and Minor Adverse Events | Major and minor adverse events will be reported following the CONSORT extension statement for harms-reporting in randomized clinical trials. Major events are defined as death or hospitalization within trial care or 3 hours after. Minor events are defined as other unwanted outcomes that requires clinician attention. | The duration of the study (weeks 1-24) | 
| Program Progression Achieved | Participants' progression during the 8-week exercise intervention will be recorded for each exercise station as the level of progression achieved in the end of the intervention. Four levels of progression are used (1-4). | Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group. | 
| Observed Exercise Fidelity | Observed exercise fidelity will be assessed using a checklist consisting of essential criteria for each exercise variation. Exercise fidelity will be expressed as percentage of exercise criteria achieved and will be recorded for each exercise as well as the complete program. | Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group. | 
| Measured Exercise Fidelity | Exercise fidelity during the group exercise sessions will be measured for all participants using inertial measurement units (IMUs). Measured exercise fidelity will be determined using a binary support vector machine classification model built to determine exercise fidelity for each exercise. Measured exercise fidelity will be expressed as percentage of exercise criteria achieved. | Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group. | 
| Average Heart Rate | Average heart rate (pbm) during the group exercise class measured using a heart rate monitor with a chest strap during the group exercise classes. | Each supervised group exercise class (twice a week for 8 weeks) | 
| Maximum Heart Rate | Maximum heart rate (pbm) during the group exercise class measured using a heart rate monitor with a chest strap during the group exercise classes. | Each supervised group exercise class (twice a week for 8 weeks) | 
| Time at Heart Rate Zone of 50 to 60 percent of HRmax | Time spent (as minutes) on heart rate zone of 50 to 60 percent of age-predicted maximum heart rate during the group exercise classes. | Each supervised group exercise class (twice a week for 8 weeks) | 
| Time at Heart Rate Zone of 61 to 70 percent of HRmax | Time spent (as minutes) on heart rate zone of 61 to 70 percent of age-predicted maximum heart rate during the group exercise classes. | Each supervised group exercise class (twice a week for 8 weeks) | 
| Time at Heart Rate Zone of 71 to 80 percent of HRmax | Time spent (as minutes) on heart rate zone of 71 to 80 percent of age-predicted maximum heart rate during the group exercise classes. | Each supervised group exercise class (twice a week for 8 weeks) | 
| Time at Heart Rate Zone of 81 to 90 percent of HRmax | Time spent (as minutes) on heart rate zone of 81 to 90 percent of age-predicted maximum heart rate during the group exercise classes. | Each supervised group exercise class (twice a week for 8 weeks) | 
| Time at Heart Rate Zone of >90 percent of HRmax | Time spent (as minutes) on heart rate zone of >90 percent of age-predicted maximum heart rate during the group exercise classes. | Each supervised group exercise class (twice a week for 8 weeks) | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS consists of 42 items in five subscales: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Each item is scored on a 5-point Likert scale ranging from no problems to extreme problems. The subscale scores are summed, and the total score is transformed to a 0-100 scale with higher scores indicating better function. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Health-related Quality of Life (EQ-5D-5L) | The Canadian algorithm will be used to calculate the EuroQol 5 Dimension Questionnaire (EQ-5D-5L) score. The value set range for Canadians -0.148 (worst health status, worse than dead) to 0.949 (best health status). | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Knee Self-efficacy (K-SES) | The K-SES covers four domains of self-efficacy: 1) daily activities (seven items), 2) sport and leisure activities (five items), 3) physical activities (six items), and 4) knee function in the future (four items). The response to the 22 items is given using an 11-grade Likert scale, ranging from 0 (not at all certain about the task) to 10 (very certain about the task). The sum of item scores is calculated and divided by the number of items. The total score is transformed to a 0-100 scale with higher score indicating better self-efficacy. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Intermittent and Constant Osteoarthritis Pain (ICOAP) | The ICOAP consists of 11 items forming two subscales. Each item was scored on a 5-point Likert scale ranging from no pain to high (disability-severely limiting) pain. Sub-scale scores will be summed and the total score transformed to a 1-100 scale (higher scores indicating poorer outcome). | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Tampa Scale for Kinesiophobia (TSK) | The TSK consists of 17 items. Each item is scored on a 4-point Likert scale, ranging from 1 'strongly disagree' to 4 'strongly agree'. The range of total score is from 17 to 68. Higher scores indicate higher levels of kinesiophobia. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Healthcare Utilization | Healthcare utilization (i.e., visits to healthcare professionals, treatments, tests and services) will be based on participant self-report, on an item-by-item basis, for the 1-year period preceding testing. Current (2018) unit costs and rules from the Alberta Health Services Calgary Zone will be applied to value the health care system resources used by participants. | Baseline | 
| Knee Flexion Strength | Normalized knee flexion strength will be assessed at using hand-held isometric dynamometry. The peak isometric strength (N) scores are converted to torque values (Nm; force x distance between joint line and dynamometer position) and normalized to body weight (Nm/kg). | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Hip Abduction Strength | Normalized hip abduction strength will be assessed at using hand-held isometric dynamometry. The peak isometric strength (N) scores are converted to torque values (Nm; force x distance between joint line and dynamometer position) and normalized to body weight (Nm/kg). | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Hip Adduction Strength | Normalized hip adduction strength will be assessed at using hand-held isometric dynamometry. The peak isometric strength (N) scores are converted to torque values (Nm; force x distance between joint line and dynamometer position) and normalized to body weight (Nm/kg). | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Triple Single-Leg Hop | Each participant will perform two trials of three consecutive single-leg hops with the goal of jumping as far as possible. Both legs will be tested (starting with the non-injured leg), and the maximum distance (cm) from the two trials normalized for leg length will be recorded for each leg. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Single-Leg Hop for Distance | The test will be performed until three successful trials have been recorded for both legs. Hop distance is measured in centimeters (cm) from the toe at the push-off to the heel where the subject landed. The maximum distance (cm) from the three trials normalized for leg length will be recorded for each leg. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Y-Balance Test | Three complete rounds on each leg will be completed with three reaching distances. The maximal reach distance (cm) at the point where the most distal part of the foot reaches is measured and normalized for lower extremity length. The normalised composite score will be calculated. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Moderate-to-vigorous Physical Activity | To determine the average daily minutes of moderate-to-vigorous PA (MVPA), all participants will wear a waist-mounted accelerometer device for seven days. Minutes of MVPA will be calculated based on activity corresponding to moderate activity 3-6 metabolic equivalents of task (MET) and vigorous activity >6 MET. A log will be used to record non-wear time (i.e. water-based activities) and activities with very limited vertical movement (i.e. spin class and cycling). | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Asymmetries in Jumping Performance | Five inertial measurement units (Blue Trident IMU, Vicon Motion Systems Inc) will be attached to the body at the lower back, near the centre of mass and on the distal anteromedial aspect of each tibia. During the data collection participants will perform ten maximal countermovement jumps and ten maximal squat jumps with 30 second rest between jumps. Asymmetry in each phase will be reported as the difference between the left and right limb impulses divided by the maximum limb impulse and expressed as a percentage. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Fat mass index | Dual-energy x-ray absorptiometry (DXA) scanner will be used to capture whole body composition scans. Fat mass index will be calculated as fat mass relative to stature squared (kg/m^2). | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Body mass index | Body mass index (BMI; kg/m^2) will be calculated from height (to the nearest 0.1 cm; shoes removed) and weight (to the nearest 0.1 kg) assessed using a medical scale and stadiometer. | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Lean mass index | Dual-energy x-ray absorptiometry (DXA) scanner will be used to capture whole body composition scans. Lean mass index will be calculated as lean mass relative to stature squared (kg/m2). | Baseline, 8-weeks, 16-weeks and 24-weeks | 
| Number of Exercise Sessions Completed during the Maintenance Stage | The total number of times the home exercise session was completed during the maintenance stage will be recorded. | Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group) | 
| Weekly Time Spent Completing the Program during the Maintenance Stage | The weekly minutes spent completing the home exercise sessions during the maintenance stage will be recorded. | Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group) | 
| Joint-specific Adverse Events during the Maintenance Stage | The number of joint-specific adverse events will be recorded during the maintenance stage. Joint-specific adverse events are determined as participant not attending an exercise session and/or ceasing participation due to increased pain or problems in the index knee and self-reported pain greater than 5 on a scale of 0 to 10 scale after an exercise session. | Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group) | 
| Consultations with the Study Physiotherapist during the Maintenance Stage | Total number of times the participants consulted the study physiotherapist during the maintenance stage to discuss their home exercise program. | Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, prevention, exercise