Preventing Knee Osteoarthritis Through Exercise and Education Following Knee Injury

NCT04363476 | Unknown

• 1 other identifier: REB19-0276
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Knees Both Post-Traumatic

Keywords

osteoarthritis; prevention; exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (35)

• Retention Rate

  The duration of the study (weeks 1-24), will be calculated in the end.

• Joint-Specific Adverse Events

  The duration of the study (weeks 1-24)

• Self-reported Pain Before and After Exercise

  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

  The duration of the study (weeks 1-24)

• Program Progression 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.

Study Arms (2)

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.

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.

Other: SHRED Osteoarthritis program

Interventions

SHRED Osteoarthritis program OTHER

Combined exercise and education intervention

Control; Intervention

Eligibility Criteria

• Age: 21 Years - 33 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sustained a physician-confirmed intra-articular sport-related knee injury in age 18 years or younger

You may not qualify if:

• 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

Sponsors & Collaborators

• Sport Injury Prevention Research Centre: lead

Study Sites (1)

University of Calgary Sport Injury Prevention Research Centre

Calgary, Alberta, T2L 2L5, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 35993829 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Carolyn A Emery, PT, PhD

  Sport Injury Prevention Research Centre, University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anu M Räisänen, PT, PhD

CONTACT

14038705721; anu.raisanen@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research assistants performing testing and data entry and the investigators performing analysis will be blinded throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Step-wedge design with two parallel arms

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 27, 2020
• Study Start: January 4, 2020
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2021
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)