Trial Outcomes & Findings for Yoga for Managing Knee Osteoarthritis in Older Women: a Feasibility Study (NCT NCT01832155)

NCT ID: NCT01832155

Last Updated: 2019-11-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2019-11-01

Participant Flow

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.

No significant events and approaches for the overall study following participant enrollment/prior to group assignment.

Participant milestones

Measure	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.	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.
Beginning of Study: Baseline at 0 Week STARTED	18	18
Beginning of Study: Baseline at 0 Week COMPLETED	17	18
Beginning of Study: Baseline at 0 Week NOT COMPLETED	1	0
Mid-point of Study: 0 - 4 Weeks STARTED	17	18
Mid-point of Study: 0 - 4 Weeks COMPLETED	16	18
Mid-point of Study: 0 - 4 Weeks NOT COMPLETED	1	0
End of Study: 4 - 8 Weeks STARTED	16	18
End of Study: 4 - 8 Weeks COMPLETED	16	18
End of Study: 4 - 8 Weeks NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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.	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.
Beginning of Study: Baseline at 0 Week Withdrawal by Subject	1	0
Mid-point of Study: 0 - 4 Weeks Protocol Violation	1	0

Baseline Characteristics

Yoga for Managing Knee Osteoarthritis in Older Women: a Feasibility Study

Baseline characteristics by cohort

Measure	Wait List Control n=18 Participants 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.	Yoga Intervention n=18 Participants 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.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Age, Continuous	71.9 years STANDARD_DEVIATION 6.0 • n=5 Participants	71.9 years STANDARD_DEVIATION 5.4 • n=7 Participants	71.9 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=18 Participants 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.	Yoga Intervention n=18 Participants 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.
Absolute Value of OA Symptoms at 8 Weeks	39.3 units on a scale Standard Error 3.0	31.0 units on a scale Standard Error 3.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=18 Participants 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.	Yoga Intervention n=18 Participants 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.
Absolute Value of OA Pain at 8 Weeks	1 Number of pain medication/day Standard Error 1.4	1 Number of pain medication/day Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=18 Participants 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.	Yoga Intervention n=18 Participants 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.
Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks	9.0 units on a scale Standard Error .37	10.0 units on a scale Standard Error .37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=18 Participants 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.	Yoga Intervention n=18 Participants 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.
Absolute Value of Quality of Sleep at 8 Weeks	6.1 units on a scale Standard Error .52	5.0 units on a scale Standard Error .52

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=18 Participants 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.	Yoga Intervention n=18 Participants 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.
Absolute Value of Quality of Life at 8 Weeks SF12 MCS	51.7 units on a scale Standard Error 1.2	49.7 units on a scale Standard Error 1.2
Absolute Value of Quality of Life at 8 Weeks SF12 PCS	38.7 units on a scale Standard Error 1.0	38.0 units on a scale Standard Error .98
Absolute Value of Quality of Life at 8 Weeks Cantril Ladder current	7.7 units on a scale Standard Error .37	7.5 units on a scale Standard Error .37
Absolute Value of Quality of Life at 8 Weeks Cantril Ladder in 5 years	7.8 units on a scale Standard Error .32	7.2 units on a scale Standard Error .32

SECONDARY outcome

Timeframe: 8 weeks

BMI was calculated using the participant's weight and height, kg/m^2.

Outcome measures

Measure	Wait List Control n=18 Participants 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.	Yoga Intervention n=18 Participants 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.
Absolute Value of BMI at 8 Weeks	28.9 kg/m^2 Standard Error .16	28.7 kg/m^2 Standard Error .16

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=35 Participants 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.	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.
Feasibility Measures - Retention	6 classes Interval 1.0 to 8.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=33 Participants 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.	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.
Feasibility Measures - Adherence	112 minutes/week Interval 21.0 to 190.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=35 Participants 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.	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.
Feasibility Measure - Acceptability Level of difficulty	4 units on a scale Interval 0.0 to 9.0	—
Feasibility Measure - Acceptability level of enjoyment	9 units on a scale Interval 5.0 to 10.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Wait List Control n=36 Participants 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.	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.
Feasibility Measure - Safety Number of yoga related injuries in class	0 injuries	—
Feasibility Measure - Safety Number of yoga home practice related injuries	0 injuries	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

The number of months it took to recruit 36 participants.

Outcome measures

Measure	Wait List Control n=36 Participants 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.	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.
Feasibility Measure - Recruitment	9 months	—

Adverse Events

Wait List Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Yoga Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Corjena Cheung, Assistant Professor

University of Minnesota

Phone: 612-624-5198

Email: corjena@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place