A Biomechanical Exercise Program for Knee OA

NCT ID: NCT02370667

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-07-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Biomechanical Exercise (BE)

The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.

Group Type: EXPERIMENTAL

Biomechanical Exercise (BE)

Intervention Type: OTHER

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)

The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.

Group Type: ACTIVE_COMPARATOR

Traditional Exercise (TE)

Intervention Type: OTHER

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)

The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.

Group Type: OTHER

Meditation Control (M)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica R Maly, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29664955 (View on PubMed)

Other Identifiers

BiomechanicalExerciseProgram

Identifier Type: -

Identifier Source: org_study_id