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治験 NCT06826534（対象：心血管合併症、化学療法毒性）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
At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
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 NCT06826534 は 介入研究 臨床試験 で、心血管合併症、化学療法毒性 に関するものです。現在は 募集中 で、2023年10月20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 Children's Hospital Los Angeles によって主催され、2025年12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14日 です。
概要
The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are
- To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors.
- To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance.
- To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications.
- Hypothesis: Pediatric cancer survivors who implement exercise and dietary recommendations will demonstrate improvement in cardiovascular fitness and general wellness. A multidisciplinary team approach can facilitate adherence to a moderately rigorous exercise prescription, and thus enhance the health benefits of a CORE program at CHLA.
Participants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.
公式タイトル
At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
疾患／病気
心血管合併症化学療法毒性その他の研究識別子
- CHLA-22-00323
NCT番号
開始日
2023-10-20
最終更新日
2025-02-14
終了予定日
2025-12-31
目標参加者数
20
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
anthracycline exposure
cancer survivors
physical activity
pediatric oncology
cardiac rehabilitation
cancer survivors
physical activity
pediatric oncology
cardiac rehabilitation
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
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Treatment Arm | Cardio-oncology Rehabilitation Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week |
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 cardiovascular fitness after completion of a 6-month exercise intervention. | Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing. | Baseline to 6 months |
Change in cardiovascular fitness after completion of a 6-month exercise intervention. | Ve/VCO2 slope (predictor of cardiac mortality) as measured by cardiopulmonary exercise testing. | Baseline to 6 months |
Change in cardiovascular fitness after completion of a 6-month exercise intervention. | Chronotropic response (heart rate response to exercise) as measured by cardiopulmonary exercise testing. | Baseline to 6 months |
Change in cardiovascular fitness after completion of a 6-month exercise intervention. | Blood pressure response to exercise as measured by cardiopulmonary exercise testing. | Baseline to 6 months |
Change in cardiac function after completion of a 6-month exercise intervention. | Cardiac function will be assessed via echocardiogram. | Baseline to 6 months |
Change in cardiac rhythm after completion of a 6-month exercise intervention. | Cardiac rhythm will be assessed via EKG. | Baseline to 6 months |
Change in cardiac stress after completion of a 6-month exercise intervention. | Cardiac stress will be assessed via NT-proBNP level. | Baseline to 6 months |
Average change in triglyceride level as measured from baseline to 6 months. | Triglyceride (mg/dL) will be measured. | Baseline to 6 months |
Average change in total cholesterol level as measured from baseline to 6 months. | Total cholesterol (mg/dL) will be measured. | Baseline to 6 months |
Average change in high density lipoprotein level as measured from baseline to 6 months. | High density lipoprotein (HDL) (mg/dL) will be measured. | Baseline to 6 months |
Average change in low density lipoprotein as measured from baseline to 6 months. | Low density lipoprotein (LDL) (mg/dL) will be measured. | Baseline to 6 months |
Average change in very low density lipoprotein as measured from baseline to 6 months. | Very low density lipoprotein (VLDL) (mg/dL) will be measured. | Baseline to 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Average change in reported quality of life from baseline to 6 months | PedsQL(TM) Measurement Model will be used, which assesses physical, emotional, social, school functioning domains. | Baseline to 6 months |
Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months | Lifestyle habits will be assessed via exercise and dietary surveys completed by each participant. | Baseline to 6 months |
Average change in activity level from baseline to 6 months | Activity levels will be assessed via exercise surveys as well as continuous FitBit(TM) activity data which will include weekly number of steps, average calorie burn, days of exercise, minute in activity, and average sleep time. | Baseline to 6 months |
適格基準
対象年齢
小児, 成人
試験の最低年齢
0 Years
対象性別
全て
- Patients aged of 10-21 years at enrollment
- Parent/legal guardian available for consent (if applicable), and patient available for assent and consent
- History of anthracycline exposure +/- radiation
- Currently in remission, with at least 6 months off chemotherapy
- Able to perform CPET
- Baseline CPET with VO2 <80% (at start of study, or CPET at CHLA after January 2020)
- Smartphone compatible with Fitbit (own or parent/legal guardian's)
- Ability to complete and send diary and Fitbit information on a weekly basis
- Ability to participate in monthly virtual check-in visits
- Baseline activity prior to intervention <30min/day, 2x/week
- Inability to obtain consent/assent
- Unable to accurately perform quality of life survey independently
- No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery
- Contraindication to moderate activity (>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC/AHA Stage D)
- Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies
- Unable to perform mild activity for at least 0.5h/day and at least 2x/week
- Unable to come to hospital for study visits at 0 and 6 months
- Unable to complete study-related surveys
- Unable to complete and send diary and Fitbit information on a weekly basis
- Unable to check-in monthly on virtual platform
- On beta blockade
- Pregnancy
Children's Hospital Los Angeles責任者
Jennifer Su, 研究責任者, Assistant Professor, Keck School of Medicine, University of Southern California, Children's Hospital Los Angeles
試験中央連絡先
連絡先: Obdulio Carreras, (323) 361-4663, [email protected]
連絡先: Jennifer Su, MD, (323) 361-5136, [email protected]
1 1カ国の場所
California
Children's Hospital Los Angeles, Los Angeles, California, 90027, United States
Obdulio Carreras, 連絡先, (323) 361-4663, [email protected]
Jennifer Su, MD, 連絡先, (323) 361-5136, [email protected]
Jennifer Su, MD, 研究責任者
募集中