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OsteoarthritisNCT02146105

Yoga as an Intervention for Women With Knee Osteoarthritis

A study testing Yoga For Knee Osteoarthritis in people with Osteoarthritis, 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

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. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Osteoarthritis
What is being tested?
Yoga For Knee Osteoarthritis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteCanada
Study dates
May 2014to Feb 2015
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

  • 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

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: 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.

Read the 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.

Conditions
Osteoarthritis
Being tested
Yoga For Knee Osteoarthritis
Medical subject headings
Osteoarthritis

What participants receive

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

  • Yoga For Knee OsteoarthritisOther

    Yoga program specifically for women with knee osteoarthritis.

Study groups in NCT02146105
Study groupRoleWhat they receive
Yoga For Knee OsteoarthritisExperimentalAn 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.
Receives: Other: Yoga For Knee Osteoarthritis

What is being measured

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

  1. Change in Knee Extensor Torque

    Knee extensor torque (Newton*meter) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.

    Measured: Week 1 and Week 13

  2. Change in Knee Pain

    Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.

    Measured: Week 1 and Week 13

Secondary outcomes (7)

  1. Change in Six Minute Walk Test (6MWT)

    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).

    Measured: Week 1 and Week 13

  2. Change in 30-second Chair Stand

    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.

    Measured: Week 1 and Week 13

  3. Change in Timed Up and Go (TUG)

    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.

    Measured: Week 1 and Week 13

  4. Change in Stair Ascent and Descent

    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.

    Measured: Week 1 and Week 13

  5. Change in Subjective Scales

    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.

    Measured: Week 1 and Week 13

  6. Change in Cardiovascular Fitness

    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.

    Measured: Week 1 and Week 13

  7. Change in Biomechanical Outcomes

    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.

    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 posted23 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146105
Sponsor's protocol ID
Yoga_KneeOA
Other IDs
Labarge
Status last verified
Aug 2017
First submitted
16 May 2014
Last updated
26 Sep 2017
Data monitoring committee
Yes

Publications

  • Brenneman EC, Kuntz AB, Wiebenga EG, Maly MR. A Yoga Strengthening Program Designed to Minimize the Knee Adduction Moment for Women with Knee Osteoarthritis: A Proof-Of-Principle Cohort Study. PLoS One. 2015 Sep 14;10(9):e0136854. doi: 10.1371/journal.pone.0136854. eCollection 2015.

    PubMed 26367862

Questions about this trial

What is this clinical trial studying?

A study testing Yoga For Knee Osteoarthritis in people with Osteoarthritis, 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 8 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 26 Sep 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 19 Feb 2015). 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 Knee Extensor Torque (time frame: Week 1 and Week 13). The study lists 2 primary outcomes in all. 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 NCT02146105, 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 26 Sep 2017.

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