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

Quality of Life Clinical Trial

Official title:

A Pilot Study Testing a Hatha Yoga Exercise Program in Older Women With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832155
• Other study ID #: 1101M95449
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. Potential participants were initially screened via telephone by a trained research assistant for eligibility which was based on the following inclusion criteria:

1. community-dwelling women aged 65 years or over;

2. had a symptomatic OA of knee diagnosis for at least 6 months;

3. had no previous training in any form of yoga; and

4. were not currently participating in a supervised exercise program.

2. Once initial screening eligibility was established, the individual was seen at home to confirm:

1. the presence of knee OA symptoms using the Clinical Criteria for the Classification of Idiopathic OA of the Knee developed by the American College of Rheumatology.

2. Cognitively intact using the Short Portable Mental Status Questionnaire (SPMSQ).

3. Exclusion criteria included:

• symptoms of joint locking;

• instability indicated by chronic use of a knee brace, cane, walker, or wheelchair;

• a corticosteroid injection in the symptomatic joint within three months of study entry;

• a hyaluronic acid injection in the symptomatic joint within six months of study entry;

• a history of knee surgery within the last two years or a joint replacement at any point;

• individuals who had self-reported significant medical comorbidities that might preclude exercise participation such as: a) uncontrolled high blood pressure or existing heart condition; and b) other comorbid condition with overlapping symptoms (i.e. fibromyalgia, rheumatoid arthritis);

• individuals who had medication changes for arthritis symptoms were permitted to remain in the trial; however, these changes were monitored.

4. 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.

• WOMAC scale contains 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The 5-point Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A total WOMAC score is created by summing the items for all three subscales. Higher values represent a worse OA symptom.

5. 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, balance, and timed 8" walk. Each subscale 0 (worst performance) to 12 (best performance).

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

• Quality of sleep was evaluated using the Pittsburgh Sleep Quality Index (PSQI). A 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.

• 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.

6. Feasibility measures: Feasibility was measured by eligibility, recruitment, and retention rates.

• The average number of yoga class attendance and minutes of home practice were used to measure the retention and adherence rates.

• Acceptability was evaluated by the participants' perceived difficulty of the yoga class and level of enjoyment.

• Perceived level of difficulty and enjoyment were rated by participants after completing the yoga program on two different scales of 1 - 10 where 10 represents "extremely difficult" and "most enjoyable", respectively.

• Safety was assessed by recording the frequency of injuries that occur during group and home-based exercise sessions.

7. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 86 Years

Eligibility

Inclusion Criteria:

• community-dwelling women aged 65 years or over

• had a symptomatic OA of knee diagnosis for at least 6 months

• had no previous training in any form of yoga; and

• were not currently participating in a supervised exercise program

• cognitively intact

Exclusion Criteria:

• symptoms of joint locking;

• instability indicated by chronic use of a knee brace, cane, walker, or wheelchair;

• a corticosteroid injection in the symptomatic joint within three months of study entry;

• a hyaluronic acid injection in the symptomatic joint within six months of study entry;

• a history of knee surgery within the last two years or a joint replacement at any point;

• individuals who had self-reported significant medical comorbidities that might preclude exercise participation such as: a) uncontrolled high blood pressure or existing heart condition; and b) other comorbid condition with overlapping symptoms (i.e. fibromyalgia, rheumatoid arthritis) were also be excluded.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Physical Impairment
• Poor Quality Sleep
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Midwest Nursing Center Consortium Research Network, The John A. Hartford Foundation, University of St Catherine St Paul MN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	8 Weeks
Other	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
Other	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
Other	Feasibility Measure - Recruitment	The number of months it took to recruit 36 participants.	9 months
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.	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.	8 weeks
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.	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.	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.	8 weeks
Secondary	Absolute Value of BMI at 8 Weeks	BMI was calculated using the participant's weight and height, kg/m^2.	8 weeks