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治験 NCT06491238 (MG-Ex)（対象：重症筋無力症）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
タイル表示
Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis (MG-Ex)
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 NCT06491238 (MG-Ex) は 介入研究 臨床試験 で、重症筋無力症 に関するものです。現在は 募集中 で、2024年9月16日 から開始しています。20 名の参加者 の募集が計画されています。この治験は HealthPartners Institute によって主催され、2025年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年7月15日 です。
概要
The overall purpose of this pilot study is to examine the feasibility, acceptability, and tolerability of light and moderate intensity exercise in adults with MGeffect of light vs. moderate intensity exercise on health outcomes. Participants will be enrolled into the NeuroWell exercise program, which is geared toward individuals with neurological disorders or injuries and led by Certified Exercise Physiologists (CEPs) at the HealthPartners Neuroscience Center. A total of 20 people with MG will be enrolled in this study and participate in a small group exercise program 3 times a week for 12 weeks. Participants will be randomized into two exercise groups: 1) Light intensity or 2) Moderate intensity. We hypothesize that light and moderate intensity exercise will be feasible, acceptable, and tolerable in adults with MG and that individuals in the light intensity exercise group will be able to achieve the same improvement in health outcomes as the moderate intensity group.
公式タイトル
Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis
疾患／病気
重症筋無力症その他の研究識別子
- MG-Ex
- A24-169
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Light intensity Exercise Aerobic intensity levels: Heart rate reserve (HRR) 30-39%, 9-11 Borg Rate of Perceived Exertion (RPE) Strength intensity levels: %One Repetition Max (1RM) 40-50%, OMNI RPE 1-4 | Light Intensity Exercise 12 weeks light intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries. Participants have the intensity goals descripted in the experimental arm. |
実験的Moderate intensity Exercise Aerobic intensity levels: HRR 40-59%, 12-13 Borg RPE Strength intensity levels: %1RM 60-80%, OMNI RPE 5-6 | 中強度運動 12 weeks moderate intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries. Participants have the intensity goals descripted in the experimental arm. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Feasibility of light and moderate intensity exercise | Percent of participants recruited of potential participants contacted. Range: \[0-100\]. Higher percentage indicates higher feasibility | 12 weeks |
Acceptability of light and moderate intensity exercise | Percent of participants who complete the program of participants who start the program. Range: \[0-100\]. Higher percentage indicates higher acceptability | 12 weeks |
Tolerability of light and moderate intensity exercise | Percent of classes participants complete during the course of the program. Range: \[0-100\]. Higher percentage indicates higher tolerability. | 12 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Cardiovascular Test - 6-minute walk test | Pre-post change in distance a person can walk during the 6-minute walk test. Change = Post distance - pre distance. Larger positive difference in distance indicates a larger improvement in cardiovascular health from pre-post program. | 12 weeks |
Cardiovascular and Strength test | Pre-post change in time it takes a person to transfer from seated to standing position and then back to seated position 5 times. Change = Post time- pre time. Larger positive difference in time indicates a larger improvement in cardiovascular health and strength from pre-post program. | 12 weeks |
Strength Test - 1-RM Upper Limb | Pre-post change in weight that can be lifted during the 1-RM test. Change = Post 1-RM upper limb weight -pre 1-RM upper limb weight. Larger positive difference in weight lifted indicates a larger improvement in upper limb strength from pre-post program. | 12 weeks |
Strength Test - 1-RM Lower Limb | Pre-post change in weight that can be lifted during the 1-RM test. Change = Post 1-RM lower limb weight -pre 1-RM lower limb weight. Larger positive difference in weight lifted indicates a larger improvement in lower limb strength from pre-post program. | 12 weeks |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Ability to provide and provision of signed and dated informed consent form.
- Age 18-80
- Diagnosis of generalized MG.
- On a stable MG prescription medication regimen for the last 3 months.
- Non-English speaking
- Regular exercise participation within the month prior to study enrollment or any outside exercise participation during the study intervention period.
- Significant cognitive impairment of any etiology that would impact study participation.
- History of heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion.
- History of any serious neurological, psychiatric, or substance use disorders that would impact study participation.
- Women who are currently pregnant or planning to become pregnant during the study.
- Any other medical conditions that could affect their ability to participate in exercise for the study duration (as determined by study investigators).
- Active participation or past participation ≤3 months in any other interventional research study.
- Unwilling to participate in all study related activities.
HealthPartners Institute試験中央連絡先
連絡先: Clinical Trials Coordinator, 651-495-6363, [email protected]
1 1カ国の場所
Minnesota
HealthPartners Neuroscience Center, Saint Paul, Minnesota, 55130, United States
Clinical Trial Coordinator, 連絡先, 651-495-6363, [email protected]
募集中