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| Name | Class |
|---|---|
| The John A. Hartford Foundation | OTHER |
| Midwest Nursing Center Consortium Research Network | NETWORK |
| St. Catherine University | OTHER |
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The study hypothesized that it is feasible and safe to use Hatha yoga in older women with knee osteoarthritis (OA), and practicing Hatha yoga regularly will help reduce pain and stiffness, enhance physical function, and improve quality of sleep and quality of life in older women with knee OA.
Potential participants were initially screened via telephone by a trained research assistant for eligibility which was based on the following inclusion criteria:
Once initial screening eligibility was established, the individual was seen at home to confirm:
Exclusion criteria included:
Primary outcome measures included:
- OA symptoms (e.g., pain, stiffness and physical function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1) (WOMAC) and a single question that asked about the number of pain medications used per day.
Secondary outcome measures included:
Feasibility measures: Feasibility was measured by eligibility, recruitment, and retention rates.
Demographic information (e.g., age, race/ethnic background, education level, annual household income, marital status, living arrangement, and type of insurance), and comorbidities were collected from all participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| yoga intervention | Experimental | The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home. |
|
| wait list control | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hatha yoga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Value of OA Symptoms at 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. | 8 weeks |
| Absolute Value of OA Pain at 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Value of Physical Performance of the Lower Extremities (LE) at 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Measures - Retention | 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. | 8 weeks |
| Feasibility Measures - Adherence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corjena K Cheung, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24886638 | Derived | Cheung C, Wyman JF, Resnick B, Savik K. Yoga for managing knee osteoarthritis in older women: a pilot randomized controlled trial. BMC Complement Altern Med. 2014 May 18;14:160. doi: 10.1186/1472-6882-14-160. |
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No significant events and approaches for the overall study following participant enrollment/prior to group assignment.
Recruitment took 9 months through placing flyers in various community centers; distributing press releases to the University's Alumnae Newsletter, community newsletters and newspapers; presenting health talks at community senior programs; and accessing the data base and mailing invitation letters out to patients from the University Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Beginning of Study: Baseline at 0 Week |
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| Mid-point of Study: 0 - 4 Weeks |
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| End of Study: 4 - 8 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Value of OA Symptoms at 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. | Posted | Mean | Standard Error | units on a scale | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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Limitations: Small sample size without blinding. Strengths: Randomized controlled design, data collection at multiple time points and the use of a yoga expert panel to design the yoga program specifically for older women with knee osteoarthritis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corjena Cheung, Assistant Professor | University of Minnesota | 612-624-5198 | corjena@umn.edu |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Hatha Yoga | Behavioral | The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes. |
|
| 8 weeks |
| Absolute Value of Quality of Sleep at 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. | 8 weeks |
| Absolute Value of Quality of Life at 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. | 8 weeks |
| Absolute Value of BMI at 8 Weeks | BMI was calculated using the participant's weight and height, kg/m^2. | 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. |
| 8 Weeks |
| Feasibility Measure - Acceptability | 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. | 8 weeks |
| Feasibility Measure - Safety | 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. | 8 weeks |
| Feasibility Measure - Recruitment | The number of months it took to recruit 36 participants. | 9 months |
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| NOT COMPLETED |
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| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
|
|
| Secondary | Absolute Value of Physical Performance of the Lower Extremities (LE) at 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. | Posted | Mean | Standard Error | units on a scale | 8 weeks |
|
|
|
| Secondary | Absolute Value of Quality of Sleep at 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. | Posted | Mean | Standard Error | units on a scale | 8 weeks |
|
|
|
| Secondary | Absolute Value of Quality of Life at 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. | Posted | Mean | Standard Error | units on a scale | 8 weeks |
|
|
|
| Secondary | Absolute Value of BMI at 8 Weeks | BMI was calculated using the participant's weight and height, kg/m^2. | Posted | Mean | Standard Error | kg/m^2 | 8 weeks |
|
|
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| Other Pre-specified | Feasibility Measures - Retention | 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. | Posted | Mean | Full Range | classes | 8 weeks |
|
|
|
| Other Pre-specified | Feasibility Measures - Adherence | 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. | Posted | Mean | Full Range | minutes/week | 8 Weeks |
|
|
|
| Other Pre-specified | Feasibility Measure - Acceptability | 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. | Posted | Mean | Full Range | units on a scale | 8 weeks |
|
|
|
| Other Pre-specified | Feasibility Measure - Safety | 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. | Posted | Number | injuries | 8 weeks |
|
|
|
| Primary | Absolute Value of OA Pain at 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. | Posted | Mean | Standard Error | Number of pain medication/day | 8 weeks |
|
|
|
| Other Pre-specified | Feasibility Measure - Recruitment | The number of months it took to recruit 36 participants. | Posted | Number | months | 9 months |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. 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. | 0 | 18 | 0 | 18 |
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| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| Cantril Ladder current |
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| Cantril Ladder in 5 years |
|