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

Primary Purpose

Osteoarthritis, Knee, Quality of Life, Poor Quality Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hatha yoga
Hatha Yoga
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis, Knee focused on measuring Yoga, Knee osteoarthritis, Symptom management, Older women, Pain, Stiffness, Physical function), Physical function of the lower extremities, Quality of sleep, Quality of life

Eligibility Criteria

65 Years - 86 Years (Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

yoga intervention

wait list control

Arm Description

The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
Absolute Value of BMI at 8 Weeks
BMI was calculated using the participant's weight and height, kg/m^2.

Full Information

First Posted
April 4, 2013
Last Updated
October 30, 2019
Sponsor
University of Minnesota
Collaborators
The John A. Hartford Foundation, Midwest Nursing Center Consortium Research Network, St. Catherine University
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1. Study Identification

Unique Protocol Identification Number
NCT01832155
Brief Title
Yoga for Managing Knee Osteoarthritis in Older Women: a Feasibility Study
Official Title
A Pilot Study Testing a Hatha Yoga Exercise Program in Older Women With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
The John A. Hartford Foundation, Midwest Nursing Center Consortium Research Network, St. Catherine University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Potential participants were initially screened via telephone by a trained research assistant for eligibility which was based on the following 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. Once initial screening eligibility was established, the individual was seen at home to confirm: 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. Cognitively intact using the Short Portable Mental Status Questionnaire (SPMSQ). 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. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Quality of Life, Poor Quality Sleep, Physical Impairment
Keywords
Yoga, Knee osteoarthritis, Symptom management, Older women, Pain, Stiffness, Physical function), Physical function of the lower extremities, Quality of sleep, Quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
yoga intervention
Arm Type
Experimental
Arm Description
The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.
Arm Title
wait list control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hatha yoga
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hatha Yoga
Intervention Description
The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes.
Primary Outcome Measure Information:
Title
Absolute Value of OA Symptoms at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Absolute Value of OA Pain at 8 Weeks
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Absolute Value of Quality of Sleep at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Absolute Value of Quality of Life at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Absolute Value of BMI at 8 Weeks
Description
BMI was calculated using the participant's weight and height, kg/m^2.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Feasibility Measures - Retention
Description
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.
Time Frame
8 weeks
Title
Feasibility Measures - Adherence
Description
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.
Time Frame
8 Weeks
Title
Feasibility Measure - Acceptability
Description
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.
Time Frame
8 weeks
Title
Feasibility Measure - Safety
Description
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.
Time Frame
8 weeks
Title
Feasibility Measure - Recruitment
Description
The number of months it took to recruit 36 participants.
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corjena K Cheung, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24886638
Citation
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.
Results Reference
derived

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

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