Yoga for Managing Knee Osteoarthritis in Older Women: a Feasibility Study
|ClinicalTrials.gov Identifier: NCT01832155|
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : March 4, 2014
Last Update Posted : April 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Quality of Life Poor Quality Sleep Physical Impairment||Behavioral: Hatha yoga Behavioral: Hatha Yoga||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Pilot Study Testing a Hatha Yoga Exercise Program in Older Women With Knee Osteoarthritis|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: yoga intervention
The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Behavioral: Hatha yoga
Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques.
wait list control
The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.
Behavioral: Hatha Yoga
The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes.
- Absolute Value of OA Symptoms at 8 Weeks [ Time Frame: 8 weeks ]Primary outcome measures included: OA symptoms (pain, stiffness and function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1)(WOMAC). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales resulting in a possible score of 0 - 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
- Absolute Value of OA Pain at 8 Weeks [ Time Frame: 8 weeks ]A single question that asked about the number of pain medications used per day for knee OA was also used to measure OA pain status.
- Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks [ Time Frame: 8 weeks ]Secondary outcome measures included physical performance of the LE which was assessed using the Short Physical Performance Battery (SPPB) developed by the National Institute on Aging. The test consists of three components: repeated chair stands (4 points), balance (4 points), and timed 8" walk (4 points). A maximum score of 12 points can be achieved. Higher values indicate better physical functions.
- Absolute Value of Quality of Sleep at 8 Weeks [ Time Frame: 8 weeks ]Pittsburgh Sleep Quality Index (PSQI) was used to measure quality of sleep. The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0-3 whereby 3 reflects the negative extreme on the Likert Scale. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality. A global score of ≥ 5 on the PSQI total scale, which is computed as a sum of the seven subscales (e.g., sleep quality, sleep latency, sleep duration, sleep disturbance, sleep efficiency, and use sleep medication) is associated with clinically significant sleep disruptions, including insomnia and major mood disorders.
- Absolute Value of Quality of Life at 8 Weeks [ Time Frame: 8 weeks ]The self-perceived quality of life was assessed using the Short Form Health Survey (SF-12) which measures a total of 8 health domains: 4 physical and 4 mental component summary scales. Physical Health (physical functioning, role-physical, bodily pain, and general health)and Mental Health (vitality, social functioning, role-emotional, and mental health) Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The Cantril Self-Anchoring Ladder that measures both "current" and "in 5 years" using steps from 0 to 10, where "0" represents the worst possible life and "10" represents the best possible life.
- Absolute Value of BMI at 8 Weeks [ Time Frame: 8 weeks ]BMI was calculated using the participant's weight and height, kg/m^2.
- Feasibility Measures - Retention [ Time Frame: 8 weeks ]Feasibility was measured by the retention rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Participants' class attendance (average number of classes attended) was evaluated.
- Feasibility Measures - Adherence [ Time Frame: 8 Weeks ]Feasibility was also measured by the home practice adherence rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Home yoga practice adherence was determined by participants' report of the average number of minutes of yoga practiced at home.
- Feasibility Measure - Acceptability [ Time Frame: 8 weeks ]Acceptability was evaluated by the participants' perceived difficulty of the yoga class and level of enjoyment. Upon completion of the yoga program, perceived level of program difficulty was rated by participants using a scale of 1 - 10 where 10 represents "extremely difficult" and a scale of 1 - 10 where 10 represents "most enjoyable" was used to measure perceived level of program enjoyment. Data from both intervention and wait-list control (during the intervention period) groups were collected.
- Feasibility Measure - Safety [ Time Frame: 8 weeks ]Safety was assessed by measuring the frequency of yoga related injuries that occur from group or home-based exercise sessions during the active treatment periods.
- Feasibility Measure - Recruitment [ Time Frame: 9 months ]The number of months it took to recruit 36 participants.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832155
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Corjena K Cheung, PhD||University of Minnesota - Clinical and Translational Science Institute|