رادار التجارب AI | ||
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حالة التجربة السريرية NCT04906759 لـ الضعف هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Meal Delivery and Exercise
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 NCT04906759 هي دراسة تدخُّلية لـالضعف وهي قيد التجنيد. بدأت في ٩ ذو الحجة ١٤٤٢ هـ مع خطة لتجنيد ١٠٠ مشاركًا. يقودها The University of Texas Health Science Center, Houston، ومن المتوقع اكتمالها بحلول ١١ رمضان ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٥ جمادى الآخرة ١٤٤٦ هـ.
الملخص
The purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention.
العنوان الرسمي
A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults
الحالات الطبية
الضعفمعرّفات دراسة أخرى
- HSC-MS-21-0125
- 1K23AG072042-01 (منحة/عقد NIH الأمريكي)
NCT معرّف
تاريخ البدء (فعلي)
2021-07-19
آخر تحديث مُنشور
2024-12-06
تاريخ الاكتمال (المقدر)
2026-02-28
عدد المشاركين المخطط لهم
١٠٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
homebound patients
exercise
nutrition
exercise
nutrition
الغرض الأساسي
الرعاية الداعمة
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
مزدوج
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةMeals plus exercise | Meals Plus Exercise Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. Participants will also will receive an exercise kit from the MOW driver with their first meal delivery which will contain 2 tennis balls, 2 1-pound hand weights, and one towel. Every week, the driver will give the participants a handout containing 3 exercises from the NIA Go4Life Workout-to-Go book that are designed to help with strength/endurance, balance, and flexibility20. The participants will be asked to do the 3 exercises every day, if possible, on their own. Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers. |
تجريبيةMeals only | Meals ONLY Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. they will be asked to continue their usual level of activity.Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in gait speed | this is the time one takes to walk a specified distance on level surfaces over a short distance and is measured in meters/second | 4 weeks,8 weeks,12 weeks from baseline |
Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test | Score from 0(not frail),1-2(pre frail) and 3-5(frail) | 4 weeks,8 weeks,12 weeks from baseline |
Change in measure of HSP70 (ng/mL) expression | 4 weeks,8 weeks,12 weeks from baseline | |
Change in Measure of MIP-1β (pg/mL) expression | 4 weeks,8 weeks,12 weeks from baseline | |
Change in Measure of sIL-6R (pg/mL) expression | 4 weeks,8 weeks,12 weeks from baseline |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test | The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust. | 4 weeks,8 weeks,12 weeks from baseline |
Change in grip strength | Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles .This is measured by using a dynamometer which will be squeezed by the participant 3 times in each hand.The force is measured in kilograms. | 4 weeks,8 weeks,12 weeks from baseline |
Change in daily average steps from the activity tracker | 4 weeks,8 weeks,12 weeks from baseline | |
Number of patients that required emergency room visits | 6 months post baseline visit | |
Number of patients that required hospitalization | 6 months post baseline visit | |
Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living | This consists of 6 questions and each is scored form 0(patient is very dependent)-6(patient is independent) | 4 weeks,8 weeks,12 weeks from baseline |
Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.) | This consists of 8 questions and each has a summary score range from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias. | 4 weeks,8 weeks,12 weeks from baseline |
Change in loneliness as assessed by the UCLA Loneliness Scale (ULS) | This questionnaire consists of 20 questions and each is answered from 1(never)-4(always) for a total score ranging form 20-80 | 4 weeks,8 weeks,12 weeks from baseline |
Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18) | LSNS-R total score is an equally weighted sum of twelve items. Scores range from 0 to 90, a higher number indicating a better outcome | 4 weeks,8 weeks,12 weeks from baseline |
change in measure of IL-6 (pg/mL) expression | 4 weeks,8 weeks,12 weeks from baseline | |
Change in measures of CRP (ng/mL) expression | 4 weeks,8 weeks,12 weeks from baseline | |
Change in measures of TNF-α (pg/mL) expression | 4 weeks,8 weeks,12 weeks from baseline | |
Change in measures of microbiome (fecal sample) expression | 4 weeks,8 weeks,12 weeks from baseline | |
change in IL-6 (pg/mL) as measured by the frailty status | 4 weeks,8 weeks,12 weeks from baseline | |
change in CRP (ng/mL) as measured by the frailty status | 4 weeks,8 weeks,12 weeks from baseline | |
change in TNF-α (pg/mL) as measured by the frailty status | 4 weeks,8 weeks,12 weeks from baseline | |
change in HSP70 (ng/mL) as measured by the frailty status | 4 weeks,8 weeks,12 weeks from baseline | |
change in MIP-1β (pg/mL) as measured by the frailty status | 4 weeks,8 weeks,12 weeks from baseline | |
change in sIL-6R (pg/mL) as measured by the frailty status | 4 weeks,8 weeks,12 weeks from baseline | |
change in microbiome (fecal sample) as measured by the frailty status | 4 weeks,8 weeks,12 weeks from baseline |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
60 Years
الجنس المؤهل
الكل
- homebound (normally unable to leave the home unassisted)
- frail or prefrail by The Fried Frailty Phenotype (FFP)
- medically stable
- robust by FFP
- have Mini-Cog score <3 and/or are unable to follow instructions
- have a pre-diagnosed terminal illness
- unable to ambulate
- unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.
The University of Texas Health Science Center, HoustonNational Institute on Aging (NIA)الجهة المسؤولة عن الدراسة
Jessica Lee, المحقق الرئيسي, Associate Professor, The University of Texas Health Science Center, Houston
جهة اتصال مركزية للدراسة
جهة اتصال: Jessica Lee, MD,MS, 713-500-5457, [email protected]
جهة اتصال: Paola Robles Cordova, (713) 500-7904, [email protected]
1 مواقع الدراسة في 1 بلدان
Texas
The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States
Jessica Lee, MD,MS, جهة اتصال, (713) 500-5457, [email protected]
Paola Robles Cordova, جهة اتصال, (713) 500-7904, [email protected]
قيد التجنيد