Remote Tai Chi for Knee Osteoarthritis

Официальное название

Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial

Обзор

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.

Подробное описание

Investigators will conduct a 12-month embedded, pragmatic, hybrid type 1 effectiveness-implementation, individually randomized group-treatment trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention plus routine care versus routine care alone across four health care systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, and Cleveland Clinic) in four geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio (Cleveland Clinic), Southern Florida (Cleveland Clinic). Investigators will enroll a total of 480 diverse patients with a clinical diagnosis of Knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months.

Вмешательства

• Другое Remote Tai Chi
  Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.

Первичные конечные точки

• WOMAC Pain Score [Срок оценки: 3 months from randomization]

Вторичные конечные точки (3)

• PROMIS Pain Interference score [Срок оценки: 3 months from randomization]
• SF-12 PCS score [Срок оценки: 3 months from randomization]
• Number of knee joint injections [Срок оценки: 12 months from randomization]

Критерии участия

Критерии включения

• Age 50 years or older
• Treating clinician diagnosis of knee osteoarthritis
• 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.
• Able to provide informed consent
• If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study
• If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks)
• Has access to a home computer or device that will allow telehealth (bidirectional audio and video) delivery of the intervention
• Is an active patient at one of the 4 participating healthcare system

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Tufts Medical Center — Boston

Идентификаторы

NCT: NCT06384898 · STUDY00002259 · UH3AT012413

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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