Yoga as an Intervention for Women With Knee Osteoarthritis

• Sponsor: McMaster University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02146105
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Duration (Months): 9.1
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Other: Yoga For Knee Osteoarthritis	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Yoga Exercise Intervention Designed for Women With Knee Osteoarthritis
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

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.	Other: Yoga For Knee Osteoarthritis; Yoga program specifically for women with knee osteoarthritis.

Outcome Measures

Primary Outcome Measures

1. Change in Knee Extensor Torque [Week 1 and Week 13]

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

2. Change in Knee Pain [Week 1 and Week 13]

   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

1. Change in Six Minute Walk Test (6MWT) [Week 1 and Week 13]

   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).

2. Change in 30-second Chair Stand [Week 1 and Week 13]

   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.

3. Change in Timed Up and Go (TUG) [Week 1 and Week 13]

   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.

4. Change in Stair Ascent and Descent [Week 1 and Week 13]

   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.

5. Change in Subjective Scales [Week 1 and Week 13]

   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.

6. Change in Cardiovascular Fitness [Week 1 and Week 13]

   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.

7. Change in Biomechanical Outcomes [Week 1 and Week 13]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster University	Hamilton	Ontario	Canada	L8P 3Y4

Sponsors and Collaborators

• McMaster University

Investigators

• Principal Investigator: Monica R Maly, PhD, School of Rehabilitation Sciences, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT02146105
• Other Study ID Numbers: Yoga_KneeOA; Labarge
• First Posted: May 23, 2014
• Last Update Posted: Sep 26, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Yoga Intervention
Arm/Group Description	Participants completed a yoga strengthening program designed for knee osteoarthritis (OA). This program was taught by a certified yoga instructor who was trained to deliver the strengthening program. Participants were asked to attend 3 classes per week for 12 weeks. Each class was 1 hour in duration.
Period Title: Overall Study
STARTED	45
COMPLETED	39
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Yoga For Knee Osteoarthritis
Arm/Group 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. Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis.
Overall Participants	45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.0 (6.8)
Sex: Female, Male (Count of Participants)
Female	45 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga For Knee Osteoarthritis
Arm/Group 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. Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis.
Measure Participants	45
Mean (Standard Deviation) [Nm]	130.1 (42.1)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Yoga For Knee Osteoarthritis
Arm/Group 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. Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis.
All Cause Mortality
	Yoga For Knee Osteoarthritis
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Yoga For Knee Osteoarthritis
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	Yoga For Knee Osteoarthritis
	Affected / at Risk (%)	# Events
Total	1/45 (2.2%)
Musculoskeletal and connective tissue disorders
Ankle injury	1/45 (2.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.