Osteoarthritis Knees Both Post-TraumaticNCT04363476
Preventing Knee Osteoarthritis Through Exercise and Education Following Knee Injury
A study testing SHRED Osteoarthritis program in people with Osteoarthritis Knees Both Post-Traumatic, run by Sport Injury Prevention Research Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 33 years
- Conditions the study is for
- Osteoarthritis Knees Both Post-Traumatic
- What is being tested?
- SHRED Osteoarthritis program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2020to Apr 2021
- 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 21 to 33 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sustained a physician-confirmed intra-articular sport-related knee injury in age 18 years or younger
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary Sport Injury Prevention Research Centre
Calgary, Alberta, T2L 2L5
About this study
Official title: Preventing Post-traumatic Osteoarthritis and Other Health Consequences Following Knee Joint Injury: A Pilot Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis Knees Both Post-Traumatic
- Being tested
- SHRED Osteoarthritis program
- Keywords
- osteoarthritis, prevention, exercise
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHRED Osteoarthritis programOther
Combined exercise and education intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: SHRED Osteoarthritis program |
| Control | Other | 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. Receives: Other: SHRED Osteoarthritis program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (35)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start4 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Knees Both Post-TraumaticStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Step-wedge design with two parallel arms
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sport Injury Prevention Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Emery, Sport Injury Prevention Research Centre
- Investigators
- Carolyn A Emery, PT, PhD, Principal investigator, Sport Injury Prevention Research Centre, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363476
- Sponsor's protocol ID
- REB19-0276
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Relph N, Greaves H, Armstrong R, Prior TD, Spencer S, Griffiths IB, Dey P, Langley B. Running shoes for preventing lower limb running injuries in adults. Cochrane Database Syst Rev. 2022 Aug 22;8(8):CD013368. doi: 10.1002/14651858.CD013368.pub2.
PubMed 35993829
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Post-traumatic Osteoarthritis and Other Health Consequences Following Knee Joint Injury: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04363476
- Acronym / sponsor ID
- REB19-0276
- Conditions
- Osteoarthritis Knees Both Post-Traumatic
- Keywords
- osteoarthritis, prevention, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sport Injury Prevention Research CentreUniversity, hospital or other
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 27 Apr 2020 (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.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Step-wedge design with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: SHRED Osteoarthritis program8-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. |
| Control | Other | Other: SHRED Osteoarthritis programThe 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. |
Who may qualify
- Ages
- 21 to 33 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sustained a physician-confirmed intra-articular sport-related knee injury in age 18 years or younger
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| SHRED Osteoarthritis programCombined exercise and education intervention | Other | Control, Intervention |
Primary outcome
Knee Extension Strength
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
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.
Participation Rate
Time frame: Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.
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.
35 secondary outcomes
Retention Rate
Time frame: The duration of the study (weeks 1-24), will be calculated in the end.
Joint-Specific Adverse Events
Time frame: The duration of the study (weeks 1-24)
Self-reported Pain Before and After Exercise
Time frame: 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
Time frame: The duration of the study (weeks 1-24)
Program Progression Achieved
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Each supervised group exercise class (twice a week for 8 weeks)
Maximum Heart Rate
Time frame: Each supervised group exercise class (twice a week for 8 weeks)
Time at Heart Rate Zone of 50 to 60 percent of HRmax
Time frame: Each supervised group exercise class (twice a week for 8 weeks)
Time at Heart Rate Zone of 61 to 70 percent of HRmax
Time frame: Each supervised group exercise class (twice a week for 8 weeks)
Time at Heart Rate Zone of 71 to 80 percent of HRmax
Time frame: Each supervised group exercise class (twice a week for 8 weeks)
Time at Heart Rate Zone of 81 to 90 percent of HRmax
Time frame: Each supervised group exercise class (twice a week for 8 weeks)
Time at Heart Rate Zone of >90 percent of HRmax
Time frame: Each supervised group exercise class (twice a week for 8 weeks)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Health-related Quality of Life (EQ-5D-5L)
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Knee Self-efficacy (K-SES)
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Intermittent and Constant Osteoarthritis Pain (ICOAP)
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Healthcare Utilization
Time frame: Baseline
Knee Flexion Strength
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Hip Abduction Strength
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Hip Adduction Strength
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Triple Single-Leg Hop
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Single-Leg Hop for Distance
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Y-Balance Test
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Moderate-to-vigorous Physical Activity
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Asymmetries in Jumping Performance
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Fat mass index
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Body mass index
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Lean mass index
Time frame: Baseline, 8-weeks, 16-weeks and 24-weeks
Number of Exercise Sessions Completed during the Maintenance Stage
Time frame: 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
Time frame: Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group)
Joint-specific Adverse Events during the Maintenance Stage
Time frame: 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
Time frame: Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Derived from this study: PubMed 35993829Relph N, Greaves H, Armstrong R, Prior TD, Spencer S, Griffiths IB, Dey P, Langley B. Running shoes for preventing lower limb running injuries in adults. Cochrane Database Syst Rev. 2022 Aug 22;8(8):CD013368. doi: 10.1002/14651858.CD013368.pub2.
- Individual participant dataSharing planned: No
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.
Carolyn A Emery, PT, PhD principal investigator
Sport Injury Prevention Research Centre, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHRED Osteoarthritis program in people with Osteoarthritis Knees Both Post-Traumatic, run by Sport Injury Prevention Research Centre 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anu M Räisänen, PT, PhD (14038705721, anu.raisanen@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Extension Strength (time frame: Baseline, 8-weeks, 16-weeks and 24-weeks). The study lists 2 primary outcomes in all. 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 NCT04363476, which also lists 1 linked publication.
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 27 Apr 2020.