RECRUITING

Remote Tai Chi for Knee Osteoarthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are: * Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain (WOMAC pain score, primary outcome), pain interference (PROMIS-Pain Interference, secondary outcome), and health-related quality of life at 3 months? * Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period? Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization.

Official Title

Remote Tai Chi for Knee Osteoarthritis: an Embedded Pragmatic Trial

Quick Facts

Study Start:2025-01
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06384898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 50 years or older
  2. * Treating clinician diagnosis of knee osteoarthritis
  3. * Have 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.
  4. * Able to provide informed consent
  5. * If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study
  6. * If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks)
  7. * Has access to a home computer or device that will allow telehealth (bidirectional audio and video) delivery of the intervention
  8. * Is an active patient at one of the 4 participating healthcare system
  1. * Currently practicing Tai Chi
  2. * 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
  3. * Unable to walk without a cane or other assistive device
  4. * Any previous or scheduled knee replacement
  5. * Reports severe depression defined by a Beck Depression Inventory (BDI-II) score of 29 or more.
  6. * 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').
  7. * Not English speaking
  8. * Enrollment in any other clinical trial within the last 30 days

Contacts and Locations

Study Contact

Chenchen Wang, MD, MSc
CONTACT
617-636-3251
Chenchen.Wang@tuftsmedicine.org
Sherwood Alexis, MHA, MBA
CONTACT
617-636-5405
sherwood.alexis@tuftsmedicalcenter.org

Principal Investigator

Chenchen Wang, MD, MSc
PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Robert Saper, MD, MPH
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Eric Roseen, DC, PhD
PRINCIPAL_INVESTIGATOR
Boston Medical Center
Helen Lavetrsky, MD, MS
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

Tufts Medical Center
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: Tufts Medical Center

  • Chenchen Wang, MD, MSc, PRINCIPAL_INVESTIGATOR, Tufts Medical Center
  • Robert Saper, MD, MPH, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
  • Eric Roseen, DC, PhD, PRINCIPAL_INVESTIGATOR, Boston Medical Center
  • Helen Lavetrsky, MD, MS, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01
Study Completion Date2027-10

Study Record Updates

Study Start Date2025-01
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Pragmatic Clinical Trial
  • Implementation Science
  • Mind-body Therapies
  • Tai Chi
  • Knee Osteoarthritis

Additional Relevant MeSH Terms

  • Knee Osteoarthritis