治験レーダーAI | ||
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治験 NCT04564495 (Telex)（対象：神経学的障害、脳卒中、脊髄損傷、脳性麻痺、片麻痺、片麻痺、多発性硬化症、パーキンソン病、脳外傷、横断性脊髄炎、フリードライヒ運動失調）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。 | ||
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
Home Based Tele-exercise for People With Chronic Neurological Impairments (Telex)
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 NCT04564495 (Telex) は 介入研究 臨床試験 で、神経学的障害、脳卒中、脊髄損傷、脳性麻痺、片麻痺、片麻痺、多発性硬化症、パーキンソン病、脳外傷、横断性脊髄炎、フリードライヒ運動失調 に関するものです。現在は 実施中／登録終了 で、2021年1月22日 から開始しています。60 名の参加者 の募集が計画されています。この治験は Burke Medical Research Institute によって主催され、2025年5月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年2月5日 です。
概要
To assess the impact of a 12-week virtual seated physical intervention on cardiovascular health and wellness in people with chronic neurological impairments (CNI).
詳細説明
This study aims to examine how effective seated Zoom exercise classes are for a person with CNI for addressing cardiovascular health, physical wellness and quality of life. If these classes prove to be effective, online platforms could be a viable avenue for those with CNI to exercise and increase/maintain wellness without having to leave their homes. The investigators are also attempting to determine if a class with a live instructor vs a pre-recorded class has an effect on motivation, compliance, exertion and modifications/safety.
The entire process, including screening and consenting, will be done via Zoom and Redcap, potentially providing a blueprint for the future studies. This process can enable participants to participate in studies with minimal inconvenience, expense and effort of traveling for the consent process.
公式タイトル
Home Based Tele-exercise for People With Chronic Neurological Impairments
疾患／病気
神経学的障害脳卒中脊髄損傷脳性麻痺片麻痺片麻痺多発性硬化症パーキンソン病脳外傷横断性脊髄炎フリードライヒ運動失調刊行物
この臨床試験について発表された科学記事と研究論文：- Kumar DS, Bialek A, Divecha AA, Garn RM, Currie LEJ, Friel KM. A seated virtual exercise program to improve cardiovascular function in adults with chronic neurological impairments: a randomized controlled trial. Front Rehabil Sci. 2025 Mar 26;6:1477969. doi: 10.3389/fresc.2025.1477969. eCollection 2025.
- Divecha AA, Bialek A, Kumar DS, Garn RM, Currie LEJ, Campos T, Friel KM. Effects of a 12-week, seated, virtual, home-based tele-exercise programme compared with a prerecorded video-based exercise programme in people with chronic neurological impairments: protocol for a randomised controlled trial. BMJ Open. 2023 Jan 24;13(1):e065032. doi: 10.1136/bmjopen-2022-065032.
その他の研究識別子
- Telex
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Live zoom exercise classes Participants will engage in a live zoom exercise session. Participants will undergo 45 minutes of aerobic exercise intervention, three times a week, for a period of 12 weeks. Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness. | Seated Exercise Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness. |
実薬対照薬Recorded zoom exercise classes Participants will undergo 45 minutes of aerobic exercise intervention, three times a week, for a period of 12 weeks, using a pre-recorded class that they can do according to their own schedule. Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness. | Seated Exercise Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness. |
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 in heart rate | Heart rate on last day of training compared to heart rate on first day of training | Within one week before the first intervention session to within one week after the end of intervention |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Perceived Wellness Survey | a 36-item instrument used to measure an individual's perceived health status in physical, psychological, emotional, intellectual, spiritual, and social wellness constructs | Within one week before the first intervention session to within one week after the end of intervention |
Physical Activity Enjoyment Scale | a self-assessment measure of enjoyment with their current physical activity | Within one week before the first intervention session to within one week after the end of intervention |
Short Form-36 Health Survey | measures physical health and mental health | Within one week before the first intervention session to within one week after the end of intervention |
Numerical pain rating | standardized instrument for pain assessment in clinical and research practice. It is an 11-point scale from 0 (no pain) to 10 (the most intense pain) at rest and during movement | Within one week before the first intervention session to within one week after the end of intervention |
Borg's Rating Scale of Perceived Exertion | standardized measure to evaluate perceived intensity of exertion, effort, and fatigue during physical exercise | Within one week before the first intervention session to within one week after the end of intervention |
Reason for exercise inventory | is a 24-item scale to assess the reason that motivates a person to exercise | Within one week before the first intervention session to within one week after the end of intervention |
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
- Participants with chronic (>6 months) neurological impairments
- 18 to 75 years of age
- Participants who can provide a medical clearance to participate in the program
- Participants who can remain seated for at least one hour
- Heart rate/BP considerations, per each participant's MD
- Participants must be able to don/doff HR monitor without assistance, or have assistance if necessary
- Participants must maintain their current exercise/physical activity routine during the course of the study
- Clinically stable with no other neurological, medical or cognitive impairments
- Reliable Internet connection and ability to use Zoom platform
- Participants must speak and understand English
- No contraindication/limitations to exercise
- Currently exercising 2 days or less per week
- Participants with any cognitive impairment preventing safe and accurate participation in the program
- Medical issues preventing safe participation
- Other problems possibly contraindicating autonomous exercise at home if no supervision available.
Burke Medical Research Institute連絡先情報がありません。
1 1カ国の場所
New York
Burke Neurological Institute, White Plains, New York, 10605, United States