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Yoga as an Intervention for Women With Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Yoga For Knee Osteoarthritis
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga For Knee Osteoarthritis

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 16, 2014
Last Updated
August 28, 2017
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02146105
Brief Title
Yoga as an Intervention for Women With Knee Osteoarthritis
Official Title
A Yoga Exercise Intervention Designed for Women With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga For Knee Osteoarthritis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga For Knee Osteoarthritis
Intervention Description
Yoga program specifically for women with knee osteoarthritis.
Primary Outcome Measure Information:
Title
Change in Knee Extensor Torque
Description
Knee extensor torque (Newton*meter) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.
Time Frame
Week 1 and Week 13
Title
Change in Knee Pain
Description
Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.
Time Frame
Week 1 and Week 13
Secondary Outcome Measure Information:
Title
Change in Six Minute Walk Test (6MWT)
Description
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).
Time Frame
Week 1 and Week 13
Title
Change in 30-second Chair Stand
Description
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.
Time Frame
Week 1 and Week 13
Title
Change in Timed Up and Go (TUG)
Description
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.
Time Frame
Week 1 and Week 13
Title
Change in Stair Ascent and Descent
Description
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.
Time Frame
Week 1 and Week 13
Title
Change in Subjective Scales
Description
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.
Time Frame
Week 1 and Week 13
Title
Change in Cardiovascular Fitness
Description
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.
Time Frame
Week 1 and Week 13
Title
Change in Biomechanical Outcomes
Description
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.
Time Frame
Week 1 and Week 13

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica R Maly, PhD
Organizational Affiliation
School of Rehabilitation Sciences, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 3Y4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26367862
Citation
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.
Results Reference
derived

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Yoga as an Intervention for Women With Knee Osteoarthritis

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