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治験 NCT06384898 (TAICHIKNEE)（対象：膝変形性関節症）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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Remote Tai Chi for Knee Osteoarthritis (TAICHIKNEE)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06384898 (TAICHIKNEE) は 介入研究 臨床試験 で、膝変形性関節症 に関するものです。現在は 募集中 で、2025年4月7日 から開始しています。480 名の参加者 の募集が計画されています。この治験は Tufts Medical Center によって主催され、2028年8月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年7月8日 です。
概要
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.
詳細説明
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.
公式タイトル
Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial
疾患／病気
膝変形性関節症その他の研究識別子
- TAICHIKNEE
- STUDY00002259
- UH3AT012413 (米国NIHの助成金/契約)
NCT番号
開始日
2025-04-07
最終更新日
2025-07-08
終了予定日
2028-08-31
目標参加者数
480
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Pragmatic Clinical Trial
Implementation Science
Mind-body Therapies
Tai Chi
Knee Osteoarthritis
Implementation Science
Mind-body Therapies
Tai Chi
Knee Osteoarthritis
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Tai Chi + Routine Care The intervention will be delivered via a HIPAA-secure web-based video platform. All remote Tai Chi sessions will be 60 minutes, twice a week, for 3 months. All program components will use the Yang style Tai Chi, and every session will include warm up, review of principles, meditation with movement, breathing techniques and relaxation. | Remote Tai Chi Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements. |
非介入Routine Care Participants will be encouraged to continue their ongoing care for Knee OA by their providers. In addition, primary care providers and other participating clinicians in the health system will receive information from the study team on routine care or "2019 ACR Guideline-Based Care." At the end of the 12-month trial period, routine care participants will be offered access to recordings for the full 3-month Tai Chi program (24 sessions). | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
WOMAC Pain Score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 3 months from randomization |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
PROMIS Pain Interference score | The PROMIS Pain Interference short form 6b evaluates the extent to which pain interferes with physical, emotional and social activities. The raw score ranges between 6-30 and the T score ranges between 41.0-78.3, with higher scores indicating that pain has a greater negative impact. | 3 months from randomization |
SF-12 PCS score | The 12-item Short Form Health Survey (SF-12) has two summary scales, the Mental Health Component Score (MCS) and the Physical Component Score (PCS). Both scores range from 0 to 100, with higher scores indicating better mental and physical health. | 3 months from randomization |
Number of knee joint injections | Total number of intra-articular injections identified through EHR and patient questionnaires. | 12 months from randomization |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
50 Years
対象性別
全て
- 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
- 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
Tufts Medical Center- ⚕️Boston Medical Center
カリフォルニア大学ロサンゼルス校340 件のアクティブな治験を探索- 🏥The Cleveland Clinic
- ⚕️National Center for Complementary and Integrative Health (NCCIH)
試験中央連絡先
連絡先: Chenchen Wang, MD, MSc, 617-636-3251, [email protected]
連絡先: Sherwood Alexis, MHA, MBA, 617-636-5405, [email protected]
1 1カ国の場所
Massachusetts
Tufts Medical Center, Boston, Massachusetts, 02111, United States
Sherwood Alexis, MHA, MBA, 連絡先, 617-636-5405, [email protected]
Chenchen Wang, MD, 研究責任者
William Harvey, MD, 副研究者
募集中