Clinical trial NCT04363476: Preventing Knee Osteoarthritis Through Exercise and Education Following Knee Injury
Official title: Preventing Post-traumatic Osteoarthritis and Other Health Consequences Following Knee Joint Injury: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis Knees Both Post-Traumatic
Keywords: osteoarthritis
prevention
exercise
Lead sponsor: Sport Injury Prevention Research Centre
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Step-wedge design with two parallel arms
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Extension Strength
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Participation Rate
timeFrame: 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:
measure: Retention Rate
timeFrame: The duration of the study (weeks 1-24), will be calculated in the end.
measure: Joint-Specific Adverse Events
timeFrame: The duration of the study (weeks 1-24)
measure: Self-reported Pain Before and After Exercise
timeFrame: Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.
measure: Major and Minor Adverse Events
timeFrame: The duration of the study (weeks 1-24)
measure: Program Progression Achieved
timeFrame: Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.
measure: Observed Exercise Fidelity
timeFrame: Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.
measure: Measured Exercise Fidelity
timeFrame: Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.
measure: Average Heart Rate
timeFrame: Each supervised group exercise class (twice a week for 8 weeks)
measure: Maximum Heart Rate
timeFrame: Each supervised group exercise class (twice a week for 8 weeks)
measure: Time at Heart Rate Zone of 50 to 60 percent of HRmax
timeFrame: Each supervised group exercise class (twice a week for 8 weeks)
measure: Time at Heart Rate Zone of 61 to 70 percent of HRmax
timeFrame: Each supervised group exercise class (twice a week for 8 weeks)
measure: Time at Heart Rate Zone of 71 to 80 percent of HRmax
timeFrame: Each supervised group exercise class (twice a week for 8 weeks)
measure: Time at Heart Rate Zone of 81 to 90 percent of HRmax
timeFrame: Each supervised group exercise class (twice a week for 8 weeks)
measure: Time at Heart Rate Zone of >90 percent of HRmax
timeFrame: Each supervised group exercise class (twice a week for 8 weeks)
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Health-related Quality of Life (EQ-5D-5L)
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Knee Self-efficacy (K-SES)
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Intermittent and Constant Osteoarthritis Pain (ICOAP)
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Healthcare Utilization
timeFrame: Baseline
measure: Knee Flexion Strength
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Hip Abduction Strength
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Hip Adduction Strength
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Triple Single-Leg Hop
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Single-Leg Hop for Distance
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Y-Balance Test
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Moderate-to-vigorous Physical Activity
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Asymmetries in Jumping Performance
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Fat mass index
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Body mass index
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Lean mass index
timeFrame: Baseline, 8-weeks, 16-weeks and 24-weeks
measure: Number of Exercise Sessions Completed during the Maintenance Stage
timeFrame: Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group)
measure: Weekly Time Spent Completing the Program during the Maintenance Stage
timeFrame: Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group)
measure: Joint-specific Adverse Events during the Maintenance Stage
timeFrame: Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group)
measure: Consultations with the Study Physiotherapist during the Maintenance Stage
timeFrame: Maintenance stage (weeks 9 to 24 for intervention group, weeks 17 to 24 for control group)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport Injury Prevention Research Centre
state: Alberta
Study officials:
affiliation: Sport Injury Prevention Research Centre, University of Calgary
name: Carolyn A Emery, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.