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حالة التجربة السريرية NCT06799481 لـ Cancer-related Cognitive Dysfunction، ورم الدماغ الأولي هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
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Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors

قيد التجنيد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06799481 هي دراسة تدخُّلية لـCancer-related Cognitive Dysfunction، ورم الدماغ الأولي وهي قيد التجنيد. بدأت في ١٤ شعبان ١٤٤٦ هـ مع خطة لتجنيد ٦٠ مشاركًا. يقودها جامعة إيموري، ومن المتوقع اكتمالها بحلول ٢٧ صفر ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٤ شوال ١٤٤٦ هـ.
الملخص
This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment (CRCI), physical activity in adolescent and young adult (AYA) brain tumor survivors. This clinical trial also evaluates the impact of RISE on the collection of microorganisms that exist in the intestines (gut microbiome). Up to 45% of AYA brain tumor survivors experience CRCI, including issues with attention and memory. CRCI can have a negative impact on education, independent living and can worsen long-term quality of life. Moderate-intensity levels of exercise, particularly aerobic and resistance training, have been shown to improve cognitive function. Additionally, exercise can change the composition and function of the gut microbiome, which may lead to improved cognitive function. Unfortunately, only about 50% of AYAs with cancer receive exercise information or meet the physical activity recommendations. Tailoring a virtually delivered exercise intervention to meet the unique needs of AYAs may improve access to exercise. Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may also help researchers understand the relationship of exercise on the gut microbiome and cognitive function.
وصف مفصل
PRIMARY OBJECTIVES:

I. Evaluate the feasibility of conducting a two-site pilot randomized controlled trial (RCT) to test the RISE in AYA brain tumor survivors.

II. Examine the impact of RISE on CRCI (primary) and physical activity (secondary).

EXPLORATORY OBJECTIVE:

I. Explore the impact of RISE on the gut microbiome diversity and composition.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (RISE INTERVENTION): Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.

ARM II (ATTENTION CONTROL): Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.

After completion of study intervention, patients are followed up at week 18.

العنوان الرسمي

Virtually Delivered Home-Based Exercise Intervention on Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors: A Pilot Randomized Controlled Trial

الحالات الطبية
Cancer-related Cognitive Dysfunctionورم الدماغ الأولي
معرّفات دراسة أخرى
NCT معرّف
NCT06799481
تاريخ البدء (فعلي)
2025-02-13
آخر تحديث مُنشور
2025-04-02
تاريخ الاكتمال (المقدر)
2027-07-31
عدد المشاركين المخطط لهم
٦٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الغرض الأساسي
الرعاية الداعمة
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
ثلاثي
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
تجريبيةArm I (RISE)
Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.
التمارين الهوائية
Participate in personalized, progressive aerobic training
تدخل سلوكي
Receive active lifestyle behavior coaching
تدخل عبر الإنترنت
Receive access to Physitrack
إدارة الاستبيان
Ancillary studies
تدريب المقاومة
Participating in strength training exercises
مقارن نشطArm II (attention control)
Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.
المتابعة
Receive calls from the trainer
استخدام وتقييم الأجهزة الطبية
Wear a Fitbit monitor
إدارة الاستبيان
Ancillary studies
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Enrollment
Feasibility will be ≥ 50% enrollment of eligible survivors. Descriptive statistics (e.g., frequency and percentage) will be used.
Up to 1.5 years
Adherence to research intervention of virtually supervised exercise program (RISE)
Feasibility will be ≥ 75% adherence to RISE. Descriptive statistics (e.g., frequency and percentage) will be used.
Up to 12 weeks
Retention
Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used.
Up to 12 weeks
Acceptability
Will use an 11-item acceptability questionnaire. A ≥ 4 ("agree" to "strongly agree") per item equates to acceptability. Descriptive statistics (e.g., frequency and percentage) will be used.
Up to 18 weeks
Change in physical activity levels
Will be measured by Fitbit. Physical activity estimates considered as valid if the monitor is worn ≥ 10 hours/day on ≥ 4 days. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.
Baseline up to 18 weeks
Change in cancer-related cognitive impairment
Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.
Baseline up to 18 weeks
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Gut microbiome
Fecal specimens will be collected for the gut microbiome. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.
Up to 18 weeks
Physical function
Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.
At baseline and at 12 and 18 weeks
Patient Quality of Life
Will be assessed by Patient Reported Outcomes Measurement Information System-29 recommended. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing.
At baseline and at 12 and 18 weeks
معايير الأهلية

الأعمار المؤهلة للدراسة
طفل, بالغ
العمر الأدنى للدراسة
15 Years
الجنس المؤهل
الكل
  • Age 15-39 years
  • With primary brain tumor with cranial radiotherapy
  • 6 months to 4 years post cranial radiotherapy
  • Functional Assessment of Cancer Therapy (FACT)-Cognitive Function score < 60 based on self-report (used among AYAs with non-neural cancer)
  • Able to provide informed consent/assent
  • Able to walk and receive clearance from a provider to participate based on the Physical Activity Readiness Questionnaire
  • Currently engaging in < 150 minutes of physical activity per week
  • Willing to use smartphone-based applications (app)

  • Secondary malignancies, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
  • Moderate to severe traumatic brain injury with brain damage beyond that expected from brain tumor and treatment
  • Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders
Emory University logoجامعة إيموري403 تجارب سريرية نشطة للاستكشاف
الجهة المسؤولة عن الدراسة
Jinbing Bai, المحقق الرئيسي, Principal Investigator, Emory University
جهة اتصال مركزية للدراسة
جهة اتصال: Jinbing Bai, PhD, RN, 404-727-2466, [email protected]
1 مواقع الدراسة في 1 بلدان

Georgia

Emory University Hospital, Atlanta, Georgia, 30322, United States
Emily Bush, BS, جهة اتصال, [email protected]
Jinbing Bai, PhD, RN, المحقق الرئيسي
قيد التجنيد