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治験 NCT06462560 (LIFT-OA)（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。 | ||
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インターマウンテン・ヘルスLive and Interactive Fitness Training Program (Vivo Knee OA) (LIFT-OA)
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 NCT06462560 (LIFT-OA) 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、2024年4月28日 から開始しています。334 名の参加者 の募集が計画されています。この治験は インターマウンテン・ヘルス によって主催され、2026年4月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年6月17日 です。
概要
Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice a week for 6 months and Usual Care Arm: meet with ATC and given Medbridge home exercise program for 6 months. All participants will be followed for 12 months, and will be assessed at 3-,6-, and 12-months. All participants will complete functional assessments, OA patient reported outcomes measures, quality of life, exercise self-efficacy, and fall risk questionnaires, and health care utilization report at each testing visit. A subset of Vivo participants will be asked satisfaction questions at the 3 and 6 month time points.
公式タイトル
Improving Physical Function and Quality of Life in Adults With Knee Osteoarthritis Utilizing an Online Live and Interactive Fitness Training Program (Vivo Knee OA)
疾患／病気
膝変形性関節症その他の研究識別子
- LIFT-OA
- 1052693
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
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Vivo Online Exercise program | Vivo Online Exercise Program Virtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs |
実薬対照薬Medbridge Home Exercise Program | Medbridge Home Program At home exercise program accessed through exercise descriptions and short vidoes |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Primary Endpoint 1 | Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months. | 6 months post intervention |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Secondary Endpoint 1 | Changes from baseline in WOMAC score at 3 and 6 months. | 6 months post intervention |
Secondary Endpoint 2 | Changes from baseline in length of time (seconds) to do 1-leg balance stance at 3 and 6 months. | 6 months post intervention |
Secondary Endpoint 3 | Changes from baseline in seconds to complete the 8-foot up and go at 3 and 6 months. | 6 months post intervention |
Secondary Endpoint 4 | Changes from baseline in number of knee raises completed in 2-minute knee raise at 3 and 6 months | 6 months post intervention |
Secondary Endpoint 5 | Changes from baseline in number of arm-curls done in 30 seconds at 3 and 6 months | 6 months post intervention |
Secondary Endpoint 6 | Changes from baseline in PROMIS-Plus-Osteoarthritis of the Knee (OAK) score at 3 and 6 months | 6 months post intervention |
Secondary Endpoint 7 | Changes from baseline in exercise self-efficacy scale score at 3 and 6 months | 6 months post intervention |
Secondary Endpoint 8 | Changes from baseline in quality of life (SF-36 score) at 3 and 6 months | 6 months post intervention |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
55 Years
対象性別
全て
55-85 years of age
Diagnosis of Osteoarthritis within the prior 6 months
Symptomatic OA defined as self-report:
Pain in the knee(s) on most days of the month
Difficulty with at least one of the following because of knee pain:
- walking ¼ of a mile
- climbing stairs
- getting in and out of a car, bath, or bed
- rising from a chair
- or performing shopping, cleaning, or self-care activities
Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees
Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand
Ambulatory and community-dwelling
Sedentary or insufficiently active as measured by the PAVS
Access to Wi-Fi in defined exercise space
BMI of 20-34.9 kg/m2
Document medication specific to OA and knee pain
Willing and able to provide consent
- Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)
- Diagnosis of dementia
- Inability to complete ≥1 ADLs without assistance.
- Knee surgery in the past 6 months
- Severe osteoporosis T-score < -3.5
- No concurrent enrollment in physical therapy for knee pain
- No concurrent enrollment in the Intermountain Arthrofit program
- Under the age of 55 or ≥85
- Asymptomatic OA
- Not having knee pain or having significant knee pain (WOMAC Pain score of ≤3 or ≥18)
- KL Grade 1 or 4
- BMI above 34.9 kg/m2 or ≤20 kg/m2
- Participation in formal strength training more than 30 minutes a week in the past 6 months.
- PAVS - Participating in 150 minutes per week of moderate intensity physical activity or 75 minutes of vigorous intensity activity, or an equivalent combination of moderate and vigorous intensity physical activity.
- Co-morbid disease that would threaten safety or impair ability to participate in a live and interactive strength training program
- Symptomatic or severe coronary artery disease; peripheral vascular disease
- Untreated hypertension
- Active cancer other than skin cancer
インターマウンテン・ヘルス28 件のアクティブな治験を探索Impactiv, Inc.試験中央連絡先
連絡先: Amelia Millward, 801-507-8095, [email protected]
1 1カ国の場所
Utah
Intermountain Health, Murray, Utah, 84107, United States
Amelia Millward, 連絡先, 801-507-8095, [email protected]
Anthony Beutler, MD, 研究責任者
募集中