A Biomechanical Exercise Program for Knee OA

Osteoarthritis, Knee Clinical Trial

Official title:

Clinical and Tissue Outcomes of a Biomechanical Exercise Program for Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02370667
• Other study ID #: BiomechanicalExerciseProgram
• Status: Active, not recruiting
• Phase: N/A
• First received: February 9, 2015
• Last updated: August 24, 2015
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Prescribing exercise for people with painful knee osteoarthritis (OA) is essential for pain management, improved function, and chronic disease prevention. Exercise that decreases joint exposure to damaging loading while eliciting adequate muscular activation for strength improvements is ideal. The purpose of this 3-arm RCT is to compare mobility, strength, pain, and MRI outcomes between the low-loading biomechanical exercise program (BE), a traditional exercise program for knee OA (TE), and a control group completing meditation classes (M).

Description:

Osteoarthritis (OA) is a common joint disease affecting 1 in 10 Canadians. Osteoarthritis commonly presents in the knee joint and is associated with mobility limitations, pain, and an increased risk of other chronic health conditions such as heart disease. It is critical to implement exercise for people with knee OA as it can be an effective method for improving pain, mobility, and cardiovascular health. A biomechanical exercise program using static yoga postures has been established in the investigators lab based on minimizing damaging knee joint loads, while effectively exercising the musculature around the knee joint. The investigators pilot project (REB#13-510) showed that a 12-week yoga program using these biomechanical exercises improved pain and mobility while keeping the medial joint loading well below that experienced during normal level walking. The next step with this exercise program is to compare clinical and tissue outcomes with that of a regularly prescribed aerobic and strengthening program, as well as a control group completing meditation classes. The investigators aim to identify differences in clinical mobility performance outcomes, muscle and fat volumes using magnetic resonance imaging (MRI), and cartilage integrity using MRI between the three groups using a randomized controlled trial (RCT) design.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 50 years of age or older

• Knee pain on most days of the week

• Less than 30 minutes of morning stiffness

• Bony enlargement

• Bony tenderness to palpation

• Signs of inflammation

• Able to safely climb 2 flights of stairs without aid

Exclusion Criteria:

• Any other forms of arthritis

• Osteoporosis

• History of patellofemoral symptoms

• Active non-arthritic knee disease

• Knee surgery

• Use of cane or walking aid

• Unstable heart condition

• Neurological conditions

• Skin allergy to medical tape

• Hip or ankle injuries in past 3 months

• Any injuries that would prohibit participation in yoga

• Ipsilateral hip or ankle conditions

• Currently receiving cancer treatment

• Currently pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Biomechanical Exercise (BE)
A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.
• Traditional Exercise (TE)
A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.
• Meditation Control (M)
A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lower extremity function	The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Higher scores represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures.	Week 1 and Week 13	No
Secondary	Change in self-reported knee pain	Change in self-reported knee pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Intermittent and Constant Osteoarthritis Pain (ICOAP) score, and the Numeric Pain Rating Scale (NPRS).	Week 1 and Week 13	No
Secondary	Change in arthritis-related self-efficacy	The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Higher numbers indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.	Week 1 and Week 13	No
Secondary	Change in depression status	Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep.	Week 1 and Week 13	No
Secondary	Change in frailty status	Frailty will be assessed using the Edmonton Frail Scale (EFS). The EFS is a brief screening interview for older adults to assess frailty that is commonly used in both inpatient and outpatient settings. The scale covers 8 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance (defined as performance on the Timed Up and Go [TUG] test). The test is scored out of 17, with higher scores indicating higher levels of frailty.	Week 1 and Week 13	No
Secondary	Change in mobility performance	Mobility performance will be measured using the Six-Minute Walk Test (6MWT), 40-metre Fast Paced Walk, Stair Climbing, 30-second Chair Stand Test, and the Timed Up and Go (TUG). All measures have produced reliable and valid data in persons with knee OA.	Week 1 and Week 13	No
Secondary	Change in isometric knee extensor and flexor strength	The peak torque developed during knee extension and flexion during a maximum voluntary isometric contraction will be measured by use of a Biodex System 2 isokinetic dynamometer. Data will be presented as Nm/kg.	Week 1 and Week 13	No
Secondary	Change in isokinetic knee extensor and flexor power	The peak isokinetic torque developed during knee extension and flexion at 25% resistance of their maximum voluntary isometric contraction will be measured by use of a Biodex System 2 isokinetic dynamometer. Data will be expressed in W/kg.	Week 1 and Week 13	No
Secondary	Change in grip strength	Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values will be expressed in both absolute (Nm) and relative (Nm/kg) values for comparison across participants.	Week 1 and Week 13	No
Secondary	Change in cardiovascular fitness	Cardiovascular fitness will be calculated using the YMCA submaximal cycle ergometry test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor) and load (Watts).	Week 1 and Week 13	No
Secondary	Change in muscle and fat volume	Muscle and fat volumes from magnetic resonance images will be segmented using a custom program. The images will be acquired using a • Iterative Decomposition of water and fat with Echo Asymmetry and Least-squares estimation (IDEAL) sequence on a 3.0T MR750 Discovery research-grade scanner.	Week 1 and Week 13	No
Secondary	Change in cartilage morphology	Cartilage morphology will be assessed in open-sourced and custom programs. Sodium (23Na+) images and T2 mapping will be completed on the 3.0T MR750 DIscovery research-grade scanner.	Week 1 and Week 13	No
Secondary	Change in inflammatory markers	Cytokines interleukin-6 (IL6), tumour necrosis factor (TNF), C-reactive protein (CRP), and interleukin-10 (IL10) are important markers of the inflammatory response. These markers will be assessed using standard blood draw and nasal swabs collected by a medical professional.	Week 1 and Week 13	No