رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT06768762 (MOST Energized) لـ استبدال الركبة 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
Optimizing a Remote-based Physical Activity Intervention for Adults with Total Knee Replacement (MOST Energized)
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 NCT06768762 (MOST Energized) هي دراسة تدخُّلية لـاستبدال الركبة وهي قيد التجنيد. بدأت في ٢١ رجب ١٤٤٦ هـ مع خطة لتجنيد ٣٣٦ مشاركًا. يقودها جامعة كارولاينا الجنوبية، ومن المتوقع اكتمالها بحلول ١٩ ربيع الأول ١٤٥١ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٧ رمضان ١٤٤٦ هـ.
الملخص
The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases in physical activity (total MVPA and percent meeting guidelines [≥150 min/week of MVPA]) in adults with knee replacement at 6 and 12 months. Secondary outcomes will examine changes in pain and physical function.
وصف مفصل
All participants will receive a 6-month, fully automated online behavioral exercise program (Energize! Exercise Program). This program is designed to increase moderate-intensity physical activity among individuals who engage in little to no physical activity at baseline. Over the course of the program, participants are given a physical activity goal which starts at 75 minutes per week and gradually progresses to 200 minutes per week. Participants are instructed to view a 10-15-minute video lesson weekly, during months 1-3, and monthly during months 4-6. These lessons teach behavioral principles for increasing exercise and maintaining physical activity long-term. Participants are also asked to complete an 'Apply Your Knowledge' activity after watching each video lesson. These activities are designed to help the participant engage more with the lesson content, with a particular emphasis on applying the content to their lives. Within this program, participants are also asked to plan and report their exercise each week, and automated feedback is provided based upon their weekly physical activity reports.
In addition to receiving the Energize! Exercise Program, participants will be randomly assigned to receive 0-4 supplemental intervention components (phone coaching, progress reports to providers, 'Hear From Others' videos, and individualized feedback) which are each described in more detail below.
العنوان الرسمي
Optimizing a Remote-based Physical Activity Intervention for Adults with Total Knee Replacement
الحالات الطبية
استبدال الركبةمعرّفات دراسة أخرى
- MOST Energized
- Pro00136251
- R01AG088083 (منحة/عقد NIH الأمريكي)
NCT معرّف
تاريخ البدء (فعلي)
2025-01-21
آخر تحديث مُنشور
2025-03-07
تاريخ الاكتمال (المقدر)
2029-07-31
عدد المشاركين المخطط لهم
٣٣٦
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
knee replacement
exercise
online
exercise
online
الغرض الأساسي
وقاية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم العاملي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةExperimental condition 1 Energize Online Program plus phone coaching, progress reports to physicians, 'Hear From Others' videos, and individualized feedback | Phone Coaching Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes. Progress Reports to Providers Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months. 'Hear from Others' Videos Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity. Individualized Feedback Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 2 Energize Online Program plus phone coaching, progress reports to physicians, and 'Hear From Others' videos | Phone Coaching Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes. Progress Reports to Providers Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months. 'Hear from Others' Videos Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 3 Energize Online Program plus phone coaching, progress reports to physicians, and individualized feedback | Phone Coaching Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes. Progress Reports to Providers Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months. Individualized Feedback Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 4 Energize Online Program plus phone coaching and progress reports to physicians | Phone Coaching Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes. Progress Reports to Providers Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 5 Energize Online Program plus phone coaching, 'Hear From Others' videos, and individualized feedback | Phone Coaching Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes. 'Hear from Others' Videos Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity. Individualized Feedback Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 6 Energize Online Program plus phone coaching and 'Hear From Others' videos | Phone Coaching Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes. 'Hear from Others' Videos Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 7 Energize Online Program plus phone coaching and individualized feedback | Phone Coaching Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes. Individualized Feedback Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 8 Energize Online Program plus phone coaching | Phone Coaching Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 9 Energize Online Program plus progress reports to physicians, 'Hear From Others' videos, and individualized feedback | Progress Reports to Providers Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months. 'Hear from Others' Videos Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity. Individualized Feedback Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 10 Energize Online Program plus progress reports to physicians and 'Hear From Others' videos | Progress Reports to Providers Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months. 'Hear from Others' Videos Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 11 Energize Online Program plus progress reports to physicians and individualized feedback | Progress Reports to Providers Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months. Individualized Feedback Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 12 Energize Online Program plus progress reports to physicians | Progress Reports to Providers Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 13 Energize Online Program plus 'Hear From Others' videos and individualized feedback | 'Hear from Others' Videos Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity. Individualized Feedback Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 14 Energize Online Program plus 'Hear From Others' videos | 'Hear from Others' Videos Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 15 Energize Online Program plus individualized feedback | Individualized Feedback Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6. Online Exercise Program MOST Energized! Online Exercise Program |
تجريبيةExperimental condition 16 Energize Online Program | Online Exercise Program MOST Energized! Online Exercise Program |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Physical activity (min/week) | Change in Actigraph-assessed moderate-to-vigorous intensity physical activity | Baseline to 6 months |
Percentage meeting physical activity guidelines | Percentage of participants meeting physical activity guidelines (150 minutes/week) | 6 months |
Physical activity (min/week) | Change in Actigraph-assessed moderate-to-vigorous intensity physical activity | Baseline to 12 months |
Percentage meeting physical activity guidelines | Percentage of participants meeting physical activity guidelines (150 minutes/week) | 12 months |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Pain intensity | Change in pain intensity using Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline to 6 months |
Physical Function | Change in physical function using the physical function/mobility Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline to 6 months |
Pain intensity | Change in pain intensity using Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline to 12 months |
Physical Function | Change in physical function using the physical function/mobility Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline to 12 months |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- had a knee replacement (including primary, staged or independent bilateral, or revision) at least 12 months ago
- have a computer, tablet, or smartphone with active internet access
- self-report engaging in less than 60 minutes/week of moderate-intensity physical activity
- be English-speaking and able to read consent and study materials written in English
- be willing to complete the 4 remote assessments, including physical activity monitoring
- be willing to be randomized to receive 0-4 supplemental intervention components.
- any contraindications to physical activity (e.g., chest pain)
- have a scheduled surgery within the next 12 months (e.g., hip or knee replacement)
- have a mobility limiting comorbidity unrelated to knee replacement
- live outside of the continental U.S
- do not currently have a physician or orthopedic surgeon whom they see regularly
- are currently participating in physical therapy (for knee)
- are participating in a structured weight loss or physical activity program
- unable to provide proof of knee replacement surgery
- have a BMI >40kg/m2
- score >30 on PROMIS cognitive function
الجهة المسؤولة عن الدراسة
Christine A Pellegrini, PhD, المحقق الرئيسي, Associate Professor, University of South Carolina
جهة اتصال مركزية للدراسة
جهة اتصال: Jakob Nelson, MS, 803-766-6960, [email protected]
جهة اتصال: Christine Pellegrini, PhD, 803-777-0911, [email protected]
1 مواقع الدراسة في 1 بلدان
South Carolina
University of South Carolina, Columbia, South Carolina, 29208, United States
Christine Pellegrini, جهة اتصال, 803-777-0911, [email protected]
قيد التجنيد
جامعة كارولاينا الجنوبية