Trial Outcomes & Findings for Yoga as an Intervention for Women With Knee Osteoarthritis (NCT NCT02146105)
NCT ID: NCT02146105
Last Updated: 2017-09-26
Results Overview
Knee extensor torque (Newton\*meter) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.
COMPLETED
NA
45 participants
Week 1 and Week 13
2017-09-26
Participant Flow
Participant milestones
| Measure |
Yoga Intervention
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.
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Overall Study
STARTED
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45
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Overall Study
COMPLETED
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39
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
Yoga Intervention
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.
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Overall Study
Adverse Event
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1
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Overall Study
Withdrawal by Subject
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5
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Baseline Characteristics
Yoga as an Intervention for Women With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Yoga For Knee Osteoarthritis
n=45 Participants
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.
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Age, Continuous
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61.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
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Sex: Female, Male
Female
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45 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 1 and Week 13Knee extensor torque (Newton\*meter) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.
Outcome measures
| Measure |
Yoga For Knee Osteoarthritis
n=45 Participants
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.
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|---|---|
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Change in Knee Extensor Torque
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130.1 Nm
Standard Deviation 42.1
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PRIMARY outcome
Timeframe: Week 1 and Week 13Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 13Participants 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 13Participants 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 13Participants 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 13Participants 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 13The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 13Cardiovascular 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 and Week 13Participants 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.
Outcome measures
Outcome data not reported
Adverse Events
Yoga For Knee Osteoarthritis
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Yoga For Knee Osteoarthritis
n=45 participants at risk
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.
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Musculoskeletal and connective tissue disorders
Ankle injury
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2.2%
1/45 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place