ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT06410261 (MSGH) के लिए कई स्क्लेरोसिस वर्तमान में भर्ती जारी 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
खोज पर वापस जाएँ
इलिनॉय विश्वविद्यालय, शिकागोExercise Rehabilitation Program in MS Who Use Wheelchairs as a Primary Mobility Device (MSGH)
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 NCT06410261 (MSGH) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो कई स्क्लेरोसिस से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 29 अप्रैल 2024 को हुई थी, और इसमें कुल 24 प्रतिभागियों के नामांकन की योजना है। इलिनॉय विश्वविद्यालय, शिकागो इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 जुलाई 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 20 सितंबर 2024 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Approximately 50% of people with multiple sclerosis (MS) use a wheelchair within 30 years of the initial diagnosis. Wheelchair use in MS is often associated with fatigue as a consequence of muscle weakness. Indeed, fatigue, a prevalent consequence of MS, often becomes debilitating and exhausts energetic resources when carrying-out tasks of daily life and/or interacting with the community, as these require ambulatory mobility. This experience of excessive fatigue has its roots in muscle weakness and results in reliance on a wheelchair for mobility, and the dependency on a wheelchair may further reduce muscular strength, particularly of the lower extremities. We propose that wheelchair users with MS can increase muscular strength through a personalized exercise rehabilitation, and this in turn will improve ambulatory performance and possibly reduce fatigue. To date, no research has examined the effects of this specific exercise rehabilitation program (GH method) on physical function and other disease-related outcomes in persons with MS who use wheelchairs as a primary mobility device.
विस्तृत विवरण
To date, there is a dearth of clinical trials examining exercise programs targeting wheelchair users with MS, but exercise programs are ideally suited for targeting the underlying causes of wheelchair use in this population, namely reduced lower extremity strength that manifests as excessive fatigue when undertaking tasks of daily life and/or interacting with the community. We propose examining a novel and highly relevant exercise rehabilitation program (GH method) on physical function and other disease-related outcomes in persons with MS who use wheelchairs as a primary mobility device.
There are no relevant preliminary data in wheelchair users with MS, but the GH method has been successfully applied in other chronic, disabling diseases such as chronic kidney disease (CKD). The data from our previous and ongoing application of GH in CKD has supported improvements in a range of outcomes from physical frailty through quality of life.
This proposed research will test the effects of a 6-month exercise rehabilitation program on physical function, self-reported health-related outcomes, and cognitive function in persons with MS who use wheelchairs as a primary mobility device in the community, but who are still ambulatory. These findings may guide researchers, clinicians, and exercise specialists in the advancement of future interventions for improving the lives of persons from this segment of the population with MS.
आधिकारिक शीर्षक
Randomized Pilot Study Evaluating the Effect of a 6-Month Exercise Rehabilitation Program on Physical and Cognitive Function in Persons With MS Who Use Wheelchairs as a Primary Mobility Device
चिकित्सीय स्थितियाँ
कई स्क्लेरोसिसअन्य अध्ययन आईडी
- MSGH
- STUDY2024-0273
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-04-29
अंतिम अद्यतन प्रकाशित
2024-09-20
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-07-31
नामांकन (अनुमानित)
24
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
Exercise
Rehabilitation
Physical function
Cognition
Rehabilitation
Physical function
Cognition
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
प्रयोगात्मकExercise rehabilitation program • Participants will take part in a personalized, one-hour, one-on-one muscle therapy session, two days a week, for 6 months. | Exercise Rehabilitation Program * The sessions will consist of a customized low-impact, resistance-base rehabilitation regime to increase muscle strength and functionality by focusing on isolating each targeted muscle, without increasing the participant's fatigue or pain level.
* The goal of phase one will be to start muscle activation without increasing fatigue or pain. Low intensity, single set of 30-35 repetitions for each of the targeted muscles will be performed by the participants, followed by stretching; the goal of phase two will be to progressively develop muscle strength, without increasing pain or fatigue. A single set of 20-25 repetitions for each muscle will be prescribed, followed by stretching; during phase three, the emphasis will be on further development of muscle strength, function, and endurance. |
कोई हस्तक्षेप नहींControl • Participants will complete the study measures on three separate occasions and will have the option to complete the exercise rehabilitation intervention once the study reaches completion. | निर्दिष्ट नहीं |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Physical Function | Short Physical Performance Battery (SPPB); the performance scores range between 0 (min) and 12 (max) points, higher scores reflect better physical function | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
Walking Speed | Timed 25-foot Walking Test (T25FW); the score is the average speed (25 feet divided by time, ft/s) for completing two trials. The minimum and maximum scores (time) depend on individuals' performance. A faster speed represents better ambulatory performance | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
Lower-Extremity Function | 30-Second Sit to Stand Test (30STS). The score is the number of complete repetitions of sit-to-stand movements performed during 30 seconds; the minimum value is 0 repetitions, and the maximum value depends on individuals' performance. Higher scores reflect better lower extremity function | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
Walking Endurance | Six-Minute Walk Test (6MW); the score is the total walking distance (in meters) during the 6 minutes. The minimum value is 0 meter, and the maximum value depends on individuals' performance. A longer distance (higher scores) indicates better walking endurance | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Cognitive Function | Symbol Digits Modalities Test (SDMT); the total test scores range between 0 (min) and 110 (max), higher scores indicate better cognitive function | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
Cognitive Function | California Verbal Learning Test - Second Edition (CVLT-II); the total test scores range between 0 (min) and 80 (max), higher scores indicate better cognitive function | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
Fatigue Severity | Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
Fatigue Impact | Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores reflect a greater impact of fatigue on daily life | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (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 physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (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 physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (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 physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
Exercise Behavior | Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in exercise behavior | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) |
Usual Pattern of Mobility in Various Life-Space Levels | The University of Alabama at Birmingham Study of Aging Life-Space Assessment (UAB-LSA); scores range between 0 (min) and 120 (max), higher scores indicate better mobility in various life-space levels | Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (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
- diagnosis of MS
- age above 18 years
- no relapse within last 30 days
- use of wheelchair for mobility in the community
- ability to walk at least 50 feet (or 65 steps) using an assistive device
- low risk for contraindications of physical activity indicated by no more than a single "yes"
- response on the Physical Activity Readiness Questionnaire (PAR-Q)
- willingness to complete the assessments and undergo randomization
- no diagnosis of MS
- less than 18 years of age
- not relapse-free within the last 30 days
- no use of wheelchair as primary mobility device
- no ability to walk for at least 50 feet (or 65 steps)
- high risk for contraindications based on more than a single "yes" response on the PAR-Q
- not willing to complete the testing procedures and undergo randomization
इलिनॉय विश्वविद्यालय, शिकागो207 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिएअध्ययन उत्तरदायी पक्ष
Enrico Benedetti, मुख्य अन्वेषक, Department Head, University of Illinois at Chicago
अध्ययन केंद्रीय संपर्क
संपर्क: Enrico Benedetti, MD, 312-355-1493, [email protected]
संपर्क: Ilaria Santi, 312-285-9653, [email protected]
1 1 देशों में अध्ययन स्थल
Illinois
University of Illinois at Chicago, Chicago, Illinois, 60612, United States
Enrico Benedetti, MD, संपर्क, 312-636-7778, [email protected]
भर्ती जारी