Osteoarthritis, KneeNCT01832155
Yoga for Managing Knee Osteoarthritis in Older Women: a Feasibility Study
A study testing Hatha yoga in people with Osteoarthritis, Knee and Quality of Life, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 86 years, women only
- Conditions the study is for
- Osteoarthritis, Knee, Quality of Life, Poor Quality Sleep
- What is being tested?
- Hatha yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 86 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Pilot Study Testing a Hatha Yoga Exercise Program in Older Women With Knee Osteoarthritis
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.
Read the 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.
- Being tested
- Hatha yoga
- Keywords
- Yoga, Knee osteoarthritis, Symptom management, Older women, Pain, Stiffness, Physical function), Physical function of the lower extremities, Quality of sleep, Quality of life
- Medical subject headings
- Osteoarthritis, Knee, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha yogaBehavioural
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 YogaBehavioural
The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Hatha yoga |
| 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. Receives: Behavioral: Hatha Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Absolute Value of BMI at 8 Weeks
BMI was calculated using the participant's weight and height, kg/m^2.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- The John A. Hartford Foundation, Midwest Nursing Center Consortium Research Network, St. Catherine University
- Responsible party
- Sponsor
- Investigators
- Corjena K Cheung, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832155
- Sponsor's protocol ID
- 1101M95449
- Status last verified
- Oct 2019
- First submitted
- 4 Apr 2013
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24886638
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Testing a Hatha Yoga Exercise Program in Older Women With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01832155
- Acronym / sponsor ID
- 1101M95449
- Keywords
- Yoga, Knee osteoarthritis, Symptom management, Older women, Pain, Stiffness, Physical function), Physical function of the lower extremities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- The John A. Hartford Foundation, Midwest Nursing Center Consortium Research Network, St. Catherine University
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoga intervention | Experimental | Behavioral: Hatha yogaThe 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 | Behavioral: Hatha YogaThe 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. |
Who may qualify
- Ages
- 65 to 86 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hatha yogaHatha 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. | Behavioural | yoga intervention |
| Hatha YogaThe same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes. | Behavioural | wait list control |
Primary outcome
Absolute Value of OA Symptoms at 8 Weeks
Time frame: 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
Time frame: 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.
4 secondary outcomes
Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks
Time frame: 8 weeks
Absolute Value of Quality of Sleep at 8 Weeks
Time frame: 8 weeks
Absolute Value of Quality of Life at 8 Weeks
Time frame: 8 weeks
Absolute Value of BMI at 8 Weeks
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24886638Cheung 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.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corjena K Cheung, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha yoga in people with Osteoarthritis, Knee and Quality of Life, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Value of OA Symptoms at 8 Weeks (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.