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क्लिनिकल ट्रायल NCT06355804 के लिए कई स्क्लेरोसिस वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य

Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis

सक्रिय, भर्ती नहीं
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT06355804 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो कई स्क्लेरोसिस से जुड़ा हुआ है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 29 अप्रैल 2024 को हुई थी, और इसमें कुल 52 प्रतिभागियों के नामांकन की योजना है। इलिनॉय विश्वविद्यालय, शिकागो इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 दिसंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 17 सितंबर 2025 को अंतिम बार अपडेट की गई थी
संक्षिप्त सारांश
The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years).

Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention.

Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition.

विस्तृत विवरण
Multiple sclerosis (MS) is a prevalent neurological disease of the central nervous system that is the leading cause of neurological disability among young adults in the United States. This disease results in the progressive loss of walking, substantial worsening of cognition, symptoms of fatigue, as well as compromised quality of life (QoL). There is evidence that physical activity is beneficially associated with walking mobility, cognitive function, symptoms of fatigue, depression, anxiety, and pain in persons with MS. Nonetheless, this population is strikingly sedentary and physically inactive, including persons newly diagnosed with MS (diagnosed with MS for two years or less). Indeed, approximately 40% of persons with MS reported stopping physical activity after an MS diagnosis, and persons recently diagnosed with MS have not been included in physical activity intervention research. Yet, the early stage of MS represents an ideal time point for initiating physical activity for life-long benefits. There is further evidence that physical activity and exercises interventions delivered remotely can yield benefits in managing MS symptoms and comorbidities, and disability progression. To this end, the objective of this current study is to examine the efficacy of a 16-week remotely delivered behavioral intervention, compared with a control condition (i.e., waitlist control), for increasing physical activity and improving secondary outcomes in persons newly diagnosed with MS (disease duration ≤ 2 years). Participants will complete a series of assessments of physical activity, MS symptoms, and physical and cognitive function before and immediately after the 16-week program. The assessments involve the completion of a battery of questionnaires remotely over the Internet. The investigators will also ask that participants wear an accelerometer (like a pedometer) during the waking hours of the day for a 7-day period as an assessment of physical activity. The first assessments occur upon enrollment in the study (Baseline Assessment) and the second occurs right after the intervention (16- week Assessment). In this study, participants will be randomly assigned into 1 of 2 conditions: a physical activity condition (receive the intervention immediately after baseline assessment) or a waitlist condition (receive the intervention after the 16-week assessment). Participants in both conditions will receive access to an Internet delivered program for 16 weeks as well as one-on-one coaching through Zoom. The investigators will ask that participants in the physical activity condition wear a Fitbit (this is different from the accelerometer) for tracking physical activity daily during the 16- week period. The investigators will further ask that information from the Fitbit be recorded into a logbook daily.
आधिकारिक शीर्षक

Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis

चिकित्सीय स्थितियाँ
कई स्क्लेरोसिस
अन्य अध्ययन आईडी
  • STUDY2023-1565
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-04-29
अंतिम अद्यतन प्रकाशित
2025-09-17
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-12-01
नामांकन (अनुमानित)
52
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
Physical activity
Behavior change
Behavioral intervention
प्राथमिक उद्देश्य
निवारण (रोकथाम)
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुलें लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/हाथहस्तक्षेप/इलाज
प्रयोगात्मकPhysical activity condition
Participants in this arm will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15 - 30 minutes) over Zoom with a behavioral coach after the baseline assessment. Throughout the 16-week period, The investigators will ask participants to wear a Fitbit (provided) for tracking daily physical activity.
Physical Activity Condition
Participants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: * The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels. * Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity. * The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS. * The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded.
अन्यWaitlist condition
Participants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15-30 minutes) over Zoom with a behavioral coach after the follow-up assessment.
Waitlist Condition
Participants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: * The newsletters provide information on the benefits of physical activity, goal setting and monitoring, and other behavioral strategies for increasing and maintaining physical activity levels. * The newsletter will be emailed to participants weekly throughout the program. * Content on the newsletter includes knowledge and skills related to physical activity in the early stages of MS, text of individuals with MS discussing their experiences, web links, worksheets, and brochures. * The program also involves 7 one-on-one video coaching chats with a behavioral coach to guide participants through the program and navigate challenges. These chats are conducted face- to-face over Zoom and generally last about 15 - 30 minutes each. The investigators do not record these sessions.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Physical Activity Behavior
Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
Changes in the GLTEQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Physical Activity Behavior
International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
Changes in the IPAQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Physical Activity Level (Light physical activity)
Time (minutes/day) spent in light physical activity (LPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of LPA reflects a higher level of physical activity.
Changes in time spent in LPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Physical Activity Level (Moderate-to-vigorous physical activity)
Time (minutes/day) spent in moderate-to-vigorous physical activity (MVPA) will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a longer time of MVPA reflects a higher level of physical activity.
Changes in time spent in MVPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Physical Activity Level (Daily step count)
Daily step count will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); participants will wear the accelerometer on a belt around their waist during the waking hours of a 7 day period; a greater number of steps per day reflects a higher level of physical activity.
Changes in time spent in daily step count from Baseline (pre-intervention) and after 16 weeks (post-intervention)
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Health-related quality of Life
Short Form Health Status Survey (SF-12); scores range between 0 (min) and 100 (max), higher scores indicate better physical and mental aspects of quality of life.
Changes in SF-12 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Health-related Quality of Life
Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes).
Changes in MSIS-29 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Changes in fatigue severity scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Depressive Symptoms
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Changes in depressive symptoms scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
Anxiety
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Changes in anxiety scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  • aged 18 years or older
  • self-reported diagnosis of MS by a neurologist within the past 2 years
  • relapse-free for the past 30 days
  • ability to speak and read English as primary language
  • internet and e-mail access, and willingness to complete the testing and questionnaires
  • ambulatory without an assistive device (e.g., cane)
  • insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) < 14)
  • visual ability and literacy to read newsletter with font size 14 points
  • on a disease-modifying therapy.

  • pregnant
  • have elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)
University of Illinois at Chicago logoइलिनॉय विश्वविद्यालय, शिकागो
अध्ययन उत्तरदायी पक्ष
Robert W Motl, मुख्य अन्वेषक, Professor, University of Illinois at Chicago
कोई संपर्क डेटा नहीं।
1 1 देशों में अध्ययन स्थल

Illinois

University of Illinois Chicago, Chicago, Illinois, 60612, United States