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

This study has been completed.
Sponsor:
Collaborators:
The John A. Hartford Foundation
Midwest Nursing Center Consortium Research Network
University of St Catherine St Paul MN
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01832155
First received: April 4, 2013
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Quality of Life
Poor Quality Sleep
Physical Impairment
Behavioral: Hatha yoga
Behavioral: Hatha Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Pilot Study Testing a Hatha Yoga Exercise Program in Older Women With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Absolute Value of OA Symptoms at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    BMI was calculated using the participant's weight and height, kg/m^2.


Other Outcome Measures:
  • Feasibility Measures - Retention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    The number of months it took to recruit 36 participants.


Enrollment: 36
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years to 86 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832155

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
The John A. Hartford Foundation
Midwest Nursing Center Consortium Research Network
University of St Catherine St Paul MN
Investigators
Principal Investigator: Corjena K Cheung, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01832155     History of Changes
Other Study ID Numbers: Yoga4OA
Study First Received: April 4, 2013
Results First Received: July 19, 2013
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Yoga
Knee osteoarthritis
Symptom management
Older women
Pain
Stiffness
Physical function)
Physical function of the lower extremities
Quality of sleep
Quality of life

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014