- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02146105
Yoga as an Intervention for Women With Knee Osteoarthritis
August 28, 2017 updated by: McMaster University
A Yoga Exercise Intervention Designed for Women With Knee Osteoarthritis
Keeping individuals with knee osteoarthritis physically active is critically important.
Exercise is effective at reducing pain while improving physical function.
However some exercises can overload the knee, and as a result, worsen knee pain and health of the knee joint.
Yoga offers a foundation of static postures that improve muscle strength and joint flexibility.
Using sophisticated technology that allows us to calculate the loads inside the knee, the investigators have selected yoga exercises that do not overload the knee joint.
The investigators have designed a yoga exercise class that is ideal for people with knee osteoarthritis.
The purpose of the study is to investigate whether these yoga exercises increase muscle strength and reduce knee pain in women with knee osteoarthritis.
In addition, the investigators aim to show that these yoga exercises will also improve knee loads during activities, mobility and heart health.
The investigators will ask 50 women with knee osteoarthritis to participate in a 12 week yoga exercise intervention, that requires attendance to 3 classes each week.
The investigators will test strength of the leg muscles, pain, knee joint loads, mobility and cardiovascular health before and after the 12 week yoga exercise intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is an uncontrolled intervention study with repeated measures.
The intervention is a 12-week supervised exercise class featuring biomechanically sound exercises for people with knee osteoarthritis.
Measures of strength of the knee muscles, pain, biomechanics during walking and yoga, mobility and cardiovascular health will be included.
Strength will be measured on a dynamometer.
Pain will be assessed with questionnaires.
Walking and three yoga postures will be observed using motion capture system integrated with force measurements from the floor.
Mobility will be assessed during walking, stair-climbing and chair standing tasks.
Cardiovascular health will be measured during a submaximal bicycle task.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- 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
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Ontario
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Hamilton, Ontario, Canada, L8P 3Y4
- McMaster University
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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
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female - 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
- Visited a family physician within the last 12 months
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yoga For Knee Osteoarthritis
An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.
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Yoga program specifically for women with knee osteoarthritis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Knee Extensor Torque
Time Frame: Week 1 and Week 13
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Knee extensor torque (Newton*meter) is calculated on a Biodex dynamometer using an isometric protocol.
Trials are completed as a voluntary maximum effort.
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Week 1 and Week 13
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Change in Knee Pain
Time Frame: Week 1 and Week 13
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Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.
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Week 1 and Week 13
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Six Minute Walk Test (6MWT)
Time Frame: Week 1 and Week 13
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Participants are asked to walk as far as possible for a total of six minutes at a self-selected pace in an obstruction-free rectangular hallway.
Distance traveled is recorded in metres (m).
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Week 1 and Week 13
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Change in 30-second Chair Stand
Time Frame: Week 1 and Week 13
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Participants are asked to cross their arms over their chest and rise and sit back down in a chair as many times as possible in 30 seconds.
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Week 1 and Week 13
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Change in Timed Up and Go (TUG)
Time Frame: Week 1 and Week 13
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Participants are asked to raise from a standard chair, walk forward 3-metres until an orange cone is reached, walk around the cone, then walk back to the chair and sit down.
The test is to be completed as quickly and safely as possible without running.
The trial is repeated a second time and the quickest time (in seconds) is recorded.
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Week 1 and Week 13
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Change in Stair Ascent and Descent
Time Frame: Week 1 and Week 13
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Participants are asked to climb a standard flight of 9 stairs as quickly and safely as possible without compromising safety.
Stair ascent and descent are assessed individually.
Time to climb the stairs are recorded (in seconds) and averaged over two trials.
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Week 1 and Week 13
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Change in Subjective Scales
Time Frame: Week 1 and Week 13
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The Centre of Epidemiologic Studies Depression Scale (19-items), the Athens Insomnia Scale (8-items), and the Perceived Stress Scale (10-items) will be given to the participants to gather information on feelings of depression, sleeping patterns, and perceived stress, respectively.
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Week 1 and Week 13
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Change in Cardiovascular Fitness
Time Frame: Week 1 and Week 13
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Cardiovascular fitness is assessed using a sub maximal oxygen consumption cycle ergometer test.
Heart rate is monitored using a Polar Heart Rate monitor and the test is terminated upon one of two conditions: a) volitional fatigue, or b) within 10 beats of 85% of the age-predicted maximum heart rate is achieved.
Values are recorded in mL/kg/min.
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Week 1 and Week 13
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Change in Biomechanical Outcomes
Time Frame: Week 1 and Week 13
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Participants will be asked to partake in a complete kinematic, kinetic, and electromyographic analysis of gait and static postures using floor-embedded force plates, a 9-camera motion capture system, and a wireless electromyography system.
Knee adduction moment (KAM; Nm/kg), normalized electromyography to a percentage of their maximal effort (%MVIC), and muscular co-activation (%) are the variables of interest.
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Week 1 and Week 13
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Monica R Maly, PhD, School of Rehabilitation Sciences, 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.
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
May 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
May 16, 2014
First Submitted That Met QC Criteria
May 20, 2014
First Posted (Estimate)
May 23, 2014
Study Record Updates
Last Update Posted (Actual)
September 26, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yoga_KneeOA
- Labarge (Other Grant/Funding Number: Labarge Optimal Aging Initiative)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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