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Osteoarthritis, KneeNCT02370667

A Biomechanical Exercise Program for Knee OA

A study testing Biomechanical Exercise (BE) and Traditional Exercise (TE) in people with Osteoarthritis, Knee, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Biomechanical Exercise (BE) and Traditional Exercise (TE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteCanada
Study dates
Aug 2015to Jul 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Any other forms of arthritis
  • Osteoporosis
  • History of patellofemoral symptoms
  • Active non-arthritic knee disease
  • Knee surgery
  • Use of cane or walking aid
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8P 3Y4

Other trials in Canada

About this study

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

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).

Read the 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.

Being tested
Biomechanical Exercise (BE), Traditional Exercise (TE), Meditation Control (M)
Keywords
Exercise, Magnetic Resonance Imaging
Medical subject headings
Osteoarthritis, Knee, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

Study groups in NCT02370667
Study groupRoleWhat they receive
Biomechanical Exercise (BE)ExperimentalThe 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.
Receives: Other: Biomechanical Exercise (BE)
Traditional Exercise (TE)Active comparatorThe 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.
Receives: Other: Traditional Exercise (TE)
Meditation Control (M)OtherThe 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.
Receives: Other: Meditation Control (M)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 1 and Week 13

Secondary outcomes (18)

  1. Change in Self-reported Knee Pain

    Change in self-reported knee pain was 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). The KOOS pain score represents a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The NPRS pain score represents a score from 0 (no pain) to 10 (worst possible pain). NPRS ratings were provided following maximum isometric knee extensor exertions and flexor exertions. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  2. 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. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  3. Change in Depression Status

    Depression was 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. The CES-D is scored from 0 to 60 with a score of 16 or higher indicating depression. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  4. Change in Frailty Status

    Frailty was 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. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  5. Change in Mobility Performance (Six-Minute Walk Test)

    Mobility performance was measured using the Six-Minute Walk Test. For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in distance in metres (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  6. Change in Mobility Performance (40m Walk Test)

    Mobility performance was measured using the 40m Walk Test. This test measures the time taken to complete a fast-paced 40m walk. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  7. Change in Mobility Performance (30-second Chair Stand Test)

    Mobility performance was measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in number (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  8. Change in Mobility Performance (Timed Up and Go Test)

    Mobility performance was measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3m, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  9. Change in Mobility Performance (Stair Ascent)

    Mobility performance was measured using the Stair Ascent Test. For this test, the time taken to ascent nine stairs is recorded. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  10. Change in Isometric Knee Extensor and Flexor Strength

    The peak torque developed during knee extension and flexion during a maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer. The mean (95% confidence interval) difference in torque (follow-up - baseline) was computed for each of the three study arms. Data is presented as Nm/kg.

    Measured: Week 1 and Week 13

  11. 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 was measured by use of a Biodex System 2 isokinetic dynamometer. The mean (95% confidence interval) difference in power (follow-up - baseline) was computed for each of the three study arms. Data is expressed in W/kg.

    Measured: Week 1 and Week 13

  12. Change in Grip Strength (Absolute)

    Peak grip strength was assessed using a Jamar hand dynamometer. The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg. The mean (95% confidence interval) difference in absolute force (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  13. Change in Grip Strength (Relative)

    Peak grip strength was assessed using a Jamar hand dynamometer. The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg/kg (grip force/body mass). The mean (95% confidence interval) difference in relative force (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  14. 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).

    Measured: Intended to be collected on week 1 and week 13

  15. 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.

    Measured: Indented to be collected on week 1 and week 13

  16. 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. The mean (95% confidence interval) percent change from baseline to follow-up was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  17. Change in Inflammatory Markers (IL6, TNF, IL10)

    Cytokines interleukin-6 (IL6), tumour necrosis factor (TNF), 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. The mean (95% confidence interval) difference in concentration in pg/ml (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

  18. Change in Inflammatory Markers (CRP)

    C-reactive protein (CRP) is an important marker of the inflammatory response. This markers will be assessed using standard blood draw and nasal swabs collected by a medical professional. The mean (95% confidence interval) difference in concentration in ug/ml (follow-up - baseline) was computed for each of the three study arms.

    Measured: Week 1 and Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02370667
Sponsor's protocol ID
BiomechanicalExerciseProgram
Status last verified
Jan 2017
First submitted
9 Feb 2015
Last updated
10 Mar 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29664955

Questions about this trial

What is this clinical trial studying?

A study testing Biomechanical Exercise (BE) and Traditional Exercise (TE) in people with Osteoarthritis, Knee, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lower Extremity Function (time frame: Week 1 and Week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02370667, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.

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A Biomechanical Exercise Program for Knee OA | AzTrials