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治験 NCT06185023（対象：後天性失語症、失語症、Aphasia, Fluent、非流暢性失語症）は実施中／登録終了です。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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カリフォルニア大学バークレー校Effects of High-intensity Exercise Training on Physical Fitness, Cognition, Language in Post-stroke Aphasia
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 NCT06185023 は 介入研究 臨床試験 で、後天性失語症、失語症、Aphasia, Fluent、非流暢性失語症 に関するものです。現在は 実施中／登録終了 で、2023年12月12日 から開始しています。12 名の参加者 の募集が計画されています。この治験は カリフォルニア大学バークレー校 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12月3日 です。
概要
The goal of this clinical trial is to establish the feasibility and fidelity of a high-intensity exercise program for individuals with post-stroke aphasia. The main questions it aims to answer are:
- Is it feasible for stroke survivors with aphasia to participate in a long in-person physical exercise program?
- Does participation in a physical exercise program lead to physical fitness, cognitive, language and/or psychological changes?
Participants can take part in two different physical exercise interventions:
- Low intensity intervention (control intervention);
- High-intensity physical exercise intervention (target intervention).
公式タイトル
Exercising Language: Behavioral and Neurophysiological Changes After High-intensity Exercise Training in Post-stroke Aphasia
疾患／病気
後天性失語症失語症Aphasia, Fluent非流暢性失語症その他の研究識別子
- 056427-002
NCT番号
開始日
2023-12-12
最終更新日
2025-12-03
終了予定日
2025-12
目標参加者数
12
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
aphasia
physical exercise
high intensity interval training
cognition
physical fitness
balance
physical exercise
high intensity interval training
cognition
physical fitness
balance
主目的
治療
割付方法
非無作為化
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 |
|---|---|
実薬対照薬Low-intensity physical exercise The participants will participate in a low-intensity non-aerobic exercise program for 2 weeks. | Low-intensity Physical Exercise As an active control intervention, a low-intensity non-aerobic exercise program was selected that mirrors more closely the standard-of-care physical therapy currently provided to stroke patients. This control intervention will offer the same level of participant involvement and type of exercises, but without the intensity element, i.e., it will not incorporate the cardiovascular and the strengthening components. |
実験的High-intensity physical exercise The participants will take part in a high-intensity Aphasia Physical EXercise (APEX) intervention designed specifically for individuals with chronic post-stroke aphasia for 8 weeks. | High-intensity Physical Exercise We have developed a new exercise program specifically designed for individuals with post-stroke aphasia, Aphasia Physical EXercise (APEX), to provide a safe, stroke- and aphasia-friendly physical exercise intervention to achieve optimal physical fitness and cognitive/language gains. This intervention, based on published research and clinical practice recommendations, is a high-intensity interval training full-body workout optimized to accommodate the range of motor abilities and general deconditioning observed in stroke survivors. |
実験的High-intensity physical exercise - remote The participants will take part in a high-intensity Aphasia Physical EXercise (APEX) intervention designed specifically for individuals with chronic post-stroke aphasia for 4 weeks. The first week will be delivered in-person, while weeks 2-4 will be delivered remotely via live Zoom classes. | High-intensity Physical Exercise We have developed a new exercise program specifically designed for individuals with post-stroke aphasia, Aphasia Physical EXercise (APEX), to provide a safe, stroke- and aphasia-friendly physical exercise intervention to achieve optimal physical fitness and cognitive/language gains. This intervention, based on published research and clinical practice recommendations, is a high-intensity interval training full-body workout optimized to accommodate the range of motor abilities and general deconditioning observed in stroke survivors. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient | The Aphasia Quotient from the Western Aphasia Battery (a standardized language test) measures overall severity of language impairment in aphasia and ranges from 0 to 100, with lower scores indicative of more severe aphasia. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Changes in Maximal Aerobic Capacity | This is a measure of cardiorespiratory and metabolic fitness. Maximal Aerobic Capacity (VO2 Max) is the ability of the body to utilize oxygen to produce energy and is measured via a graded exercise test until volitional fatigue, while measuring consumption of oxygen with a computerized metabolic system. Typically measured on a treadmill, VO2 Max has also been found to be accurately and safely measured in stroke survivors on a recumbent stepper, which will be used in this study. A good VO2max varies greatly depending on age, and for older participants is typically between 30-40 ml/kg/min (higher values indicate greater fitness). | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
Attendance | Total number of physical exercise classes attended during the intervention. | After the intervention (3rd week for the control intervention and 9th week for the experimental intervention) |
Change on the 30-second chair stands | The number of full stands from a seated position that can be completed in 30 seconds with arms folded across the chest. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
Change on the 2-minute Step Test | The number of knee raises completed in 2 minutes, raising each knee to a point midway between the patella (kneecap) and iliac crest (top hip bone). | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
Change on the Timed Up-and-Go Test | The number of seconds it takes to get up from a seated position, walk 3 m, turn, and return to a seated position. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
Change on the Functional Reach Test | The number of inches reached forward with each arm with feet flat on the floor at hip width. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
Change in Gait Speed | The speed in meters per second for the middle 6 m of the 10 m walkway. | Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm) |
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
- aphasia following single or multiple ischemic or hemorrhagic stroke;
- at least 6 months from the last stroke;
- proficient in English before the stroke;
- at least 8 years of education;
- between the ages of 18 and 80;
- independent with ambulation without a device (single-point cane accepted);
- medically stable with no contraindications to participate in regular physical exercise as determined by the patient's own primary care provider or other treating provider.
- prior history of dementia, neurologic illness (other than stroke), or substance abuse;
- significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing;
- per self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise.
カリフォルニア大学バークレー校51 件のアクティブな治験を探索
カリフォルニア大学サンフランシスコ校704 件のアクティブな治験を探索- 🎓University of San Francisco
- 🎓California State University, East Bay
責任者
Maria Ivanova, 研究責任者, Assistant Professional Researcher, University of California, Berkeley
連絡先情報がありません。
4 1カ国の場所
California
University of California Berkeley, Berkeley, California, 94720, United States
California State University East Bay, Hayward, California, 94542, United States
University of San Francisco, San Francisco, California, 94118, United States
University of California San Francisco, San Francisco, California, 94143, United States