Clinical trial NCT02370667: A Biomechanical Exercise Program for Knee OA
Official title: Clinical and Tissue Outcomes of a Biomechanical Exercise Program for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Exercise
Magnetic Resonance Imaging
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 31
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Lower Extremity Function
timeFrame: Week 1 and Week 13
Secondary outcomes:
measure: Change in Self-reported Knee Pain
timeFrame: Week 1 and Week 13
measure: Change in Arthritis-related Self-efficacy
timeFrame: Week 1 and Week 13
measure: Change in Depression Status
timeFrame: Week 1 and Week 13
measure: Change in Frailty Status
timeFrame: Week 1 and Week 13
measure: Change in Mobility Performance (Six-Minute Walk Test)
timeFrame: Week 1 and Week 13
measure: Change in Mobility Performance (40m Walk Test)
timeFrame: Week 1 and Week 13
measure: Change in Mobility Performance (30-second Chair Stand Test)
timeFrame: Week 1 and Week 13
measure: Change in Mobility Performance (Timed Up and Go Test)
timeFrame: Week 1 and Week 13
measure: Change in Mobility Performance (Stair Ascent)
timeFrame: Week 1 and Week 13
measure: Change in Isometric Knee Extensor and Flexor Strength
timeFrame: Week 1 and Week 13
measure: Change in Isokinetic Knee Extensor and Flexor Power
timeFrame: Week 1 and Week 13
measure: Change in Grip Strength (Absolute)
timeFrame: Week 1 and Week 13
measure: Change in Grip Strength (Relative)
timeFrame: Week 1 and Week 13
measure: Change in Cardiovascular Fitness
timeFrame: Intended to be collected on week 1 and week 13
measure: Change in Muscle and Fat Volume
timeFrame: Indented to be collected on week 1 and week 13
measure: Change in Cartilage Morphology
timeFrame: Week 1 and Week 13
measure: Change in Inflammatory Markers (IL6, TNF, IL10)
timeFrame: Week 1 and Week 13
measure: Change in Inflammatory Markers (CRP)
timeFrame: Week 1 and Week 13
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Monica R Maly, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuntz AB, Chopp-Hurley JN, Brenneman EC, Karampatos S, Wiebenga EG, Adachi JD, Noseworthy MD, Maly MR. Efficacy of a biomechanically-based yoga exercise program in knee osteoarthritis: A randomized controlled trial. PLoS One. 2018 Apr 17;13(4):e0195653. doi: 10.1371/journal.pone.0195653. eCollection 2018.