A Biomechanical Exercise Program for Knee OA

NCT02370667 | Completed Results DMC

• 1 other identifier: BiomechanicalExerciseProgram
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Keywords

Exercise; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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. The LEFS is scored from 0 to 80 with 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. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.

  Week 1 and Week 13

Secondary Outcomes (18)

• Change in Self-reported Knee Pain

  Week 1 and Week 13

• Change in Arthritis-related Self-efficacy

  Week 1 and Week 13

• Change in Depression Status

  Week 1 and Week 13

• Change in Frailty Status

  Week 1 and Week 13

• Change in Mobility Performance (Six-Minute Walk Test)

  Week 1 and Week 13

Study Arms (3)

Biomechanical Exercise (BE)

EXPERIMENTAL

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.

Other: Biomechanical Exercise (BE)

Traditional Exercise (TE)

ACTIVE COMPARATOR

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.

Other: Traditional Exercise (TE)

Meditation Control (M)

OTHER

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.

Other: Meditation Control (M)

Interventions

Biomechanical Exercise (BE) 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.

Biomechanical Exercise (BE)

Traditional Exercise (TE) 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.

Traditional Exercise (TE)

Meditation Control (M) 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.

Meditation Control (M)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8P 3Y4, Canada

Location

Related Publications (1)

• 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.

  PMID: 29664955 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

* The sample was statistically underpowered to detect all potential differences between and within groups * This study involved only women thus limiting the generalizability

Results Point of Contact

• Title: Dr. Monica Maly
• Organization: McMaster University

mmaly@mcmaster.ca

905-525-9140

Study Officials

• Monica R Maly, PT, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 25, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 10, 2017
• Results First Posted: March 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)