A Biomechanical Exercise Program for Knee OA

January 18, 2017 updated by: McMaster University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8P 3Y4
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Active Comparator: 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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Lower Extremity Function
Time Frame: Week 1 and Week 13
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Self-reported Knee Pain
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Arthritis-related Self-efficacy
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Depression Status
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Frailty Status
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Mobility Performance (Six-Minute Walk Test)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Mobility Performance (40m Walk Test)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Mobility Performance (30-second Chair Stand Test)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Mobility Performance (Timed Up and Go Test)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Mobility Performance (Stair Ascent)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Isometric Knee Extensor and Flexor Strength
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Isokinetic Knee Extensor and Flexor Power
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Grip Strength (Absolute)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Grip Strength (Relative)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Cardiovascular Fitness
Time Frame: Intended to be collected on week 1 and week 13
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).
Intended to be collected on week 1 and week 13
Change in Muscle and Fat Volume
Time Frame: Indented to be collected on week 1 and week 13
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.
Indented to be collected on week 1 and week 13
Change in Cartilage Morphology
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Inflammatory Markers (IL6, TNF, IL10)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13
Change in Inflammatory Markers (CRP)
Time Frame: Week 1 and Week 13
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.
Week 1 and Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Monica R Maly, PT, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BiomechanicalExerciseProgram

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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