IRB Study Number 25-352
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institutes Medicine Institute, Wellness Institute
Description
Knee osteoarthritis (Knee OA) is a major public health problem and leads to long-term pain and
disability. More effective medical treatments are needed. Exploring how approaches to pain
management work is an urgent priority.
This research may help us understand how to help future patients with Knee OA better manage
their pain. We want to see if adding Tai Chi to the routine care for Knee OA can improve Knee
OA pain.
The study will be conducted remotely by five sites: Tufts Medical Center (TMC,) University of
California, Los Angeles (UCLA,) Boston Medical Center (BMC,) University of New Mexico
(UNM) and Cleveland Clinic. As a Cleveland Clinic patient, you are being invited to participate
by Cleveland Clinic study personnel.
We anticipate up to 108 subjects will be enrolled in this study at Cleveland Clinic with up to 480
subjects total across all sites to complete the study.
Participants will be in this research study for 12 months (1 year) and should not participate in any other studies during this time.
You will be randomly assigned to either a Tai Chi + Routine Care group or a Routine Care only
group. If you’re assigned to the Tai Chi + Routine Care group, you will receive 2 Tai Chi classes
per week over Zoom (a video platform) for the first 12 weeks (3 months) of the study.
If you’re randomly assigned to the Routine Care only group, you should not do any Tai Chi at all
for one year. You will be able to access recordings of Tai Chi classes after the one-year study
period is over.
You will also be asked to complete six sets of surveys about your Knee OA symptoms, physical
health, and psychological health during the study.
Interested patients can also complete a screening eligibility online: https://redcap.link/TAICHIKNEE_UH3_CCF
Inclusion Criteria
· Age 50 years or older
· Treating clinician diagnosis of Knee OA30
· Has a score of 40 (visual analog version) or greater on at least 1 of the 5 questions in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain) at baseline.33
· Able to provide informed consent
· If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks)
· If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study
· Has access to a home device such as computer, tablet, or smart phone that will allow telehealth (bidirectional audio and video) delivery of the intervention
· Is an active patient at one of the 5 participating HCS
Exclusion Criteria
· Currently practicing Tai Chi
· Serious medical conditions (e.g., dementia, significant neurological deficits or neurodegenerative disorder, active cancer treatment, psychosis, sensory deficits) limiting the participant’s ability to participate in the Tai Chi safely, as determined by the principal investigators
- During screening process, participants will be asked questions regarding ambulate without assistive devices or supplemental oxygen, visual impairments, hearing impairments, and ability to get up from a chair independently. If the team identifies a concern that a patient may not be able to reasonably participate due to a disability, then a decision on eligibility will be deferred until the weekly MPI, study physicians, and study staff meeting. The potential participant’s situation will be discussed among the experts and decision will be made to either include participant, exclude the participant, or obtain additional information. The decision and rationale for each potential participant undergoing review will be documented.
· Unable to walk without a cane or other assistive device
· Any previous or scheduled knee replacement
· Reports severe depression defined by a Beck Depression Inventory (BDI-II) score of 29 or more.
· Reports suicidal ideations defined by a score on BDI-II item of 2 or 3 (‘I would like to kill myself’ or ‘I would kill myself if I had the chance’).Not English speaking
· Enrollment in any other clinical trial within the last 30 days
