رادار التجارب AI | ||
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حالة التجربة السريرية NCT04122690 (PDAE in PD) لـ مرض باركنسون، علاج التمرين، الإدراك هي نشط (التجنيد مغلق). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
Partnered Dance Aerobic Exercise as a Neuroprotective, Motor and Cognitive Intervention in Parkinson's Disease (PDAE in PD)
Partnered Dance Aerobic Exercise as a Neuroprotective, Motor and Cognitive Intervention in Parkinson's Disease
- Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- PDAE in PD
- F2967-R
- IRB112770 (رقم منحة/تمويل آخر) (United States Department of Affairs)
Parkinson disease
exercise
neural imaging
dance
spatial cognition
executive function
substantia nigra
neurodegeneration
rehabilitation
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةPartnered Dance Aerobic Exercise Partnered Dance-Aerobic Exercise (PDAE) is an adapted form of Argentine tango, aka Adapted tango. Participants with PD will dance the follower role only and will dance with new partners (individuals without PD) every 15-20 minutes, a widely practiced method considered by the dance teaching community to enhance learning. Participants will engage in partnering exercises on how to interpret motor goals through touch, exercises to develop understanding of temporal relationship of movement to music, novel step introduction, connecting previously learned and novel step elements. Frequent repetition and musical stereotypes may foster implicit learning or muscle memory (i.e., motor learning, or procedural memory that involves consolidating a specific motor task into memory through repetition). Participants will not be required to memorize specific step patterns but will learn new steps in each class | PDAE Participants with PD will dance the follower role only and will dance with new partners (individuals without PD) every 15-20 minutes, a widely practiced method considered by the dance teaching community to enhance learning. Participants will engage in partnering exercises on how to interpret motor goals through touch, exercises to develop understanding of temporal relationship of movement to music, novel step introduction, connecting previously learned and novel step elements. Frequent repetition and musical stereotypes may foster implicit learning or muscle memory (i.e., motor learning, or procedural memory that involves consolidating a specific motor task into memory through repetition). Participants will not be required to memorize specific step patterns but will learn new steps in each class |
مقارن نشطWalking Aerobic Exercise Walking Aerobic Exercise (WAE) Participants in WAE will receive equivalent dose, volume, frequency, intensity and duration of exercise to the PDAE group. The investigators will receive equal contact and monitoring from study staff. WAE participants will report to the same facility and interact with the same interventionist and assistants. The investigators will participate in sessions focused on at least 60 minutes of walking with breaks ad libitum, and 1/2 hour balance and stretching. The investigators have a designated, safe and non-cluttered area for walking. WAE will also take place in groups, with research volunteers and assistants to ensure that PDAE and WAE participants both receive a socially engaging intervention. | WAE The participants will receive equal contact and monitoring from study staff. WAE participants will report to the same facility and interact with the same interventionist and assistants. The participants will participate in sessions focused on at least 60 minutes of walking with breaks ad libitum, and 1/2 hour balance and stretching. The investigators have a designated, safe and non-cluttered area for walking. WAE will also take place in groups, with research volunteers and assistants to ensure that PDAE and WAE participants both receive a socially engaging intervention |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Movement disorders Society Unified Parkinson's Disease Rating Scale Part IV total score | The primary outcome, the MDS-UPDRS-IV score measures medication related motor fluctuations, including dyskinesias, OFF-time, functional impact and complexity of fluctuations, and dystonia. The investigators will administer a monthly OFF-state diary for corroboration of these scores. | 16 months |
Corsi Blocks product score | The product score is the product of the span and number of correct trials achieved by the participant. The Corsi Blocks is a test of spatial cognition, specifically visuospatial working memory. | 16 months |
rate of change in iron accumulation in the substantia nigra pars compacta | The investigators will measure R2\* in the NM-MRI defined SNc using a published image processing and analysis method. This method leverages a standard space SNc atlas developed using control population NM-MRI data, enabling R2\* measurement in SNc with no operator-dependent segmentation steps | 16 months |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
6 minute walk test (number of meters walked in 6 minutes) | The six minute walk test is a validated test of endurance in older adults and in those with Parkinson disease. Participants are asked to walk as far as they can in 6 minutes, while being monitored and able to carry on a conversation. The distance is measured in meters. | 16 months |
cardiovascular output: V02 maximum | This sub-maximal test can estimate the participant's VO2max and initial fitness level. This test uses a method in which heart rate (HR) workload values are obtained at 2-4 points and extrapolated to predict workload at the estimated maximum HR (e.g. 220-age). VO2max is then calculated from the predicted maximum workload. | 16 months |
neural measure of spatial cognition (BOLD signal) | At each study visit T1 MPRAGE, and T2\* weighted blood oxygen level dependent (BOLD) fMRI data will be acquired at the Emory CSI, using a Siemens Prisma-Fit 3T MRI scanner with a 64 channel receive-only head coil in a protocol with total scan time one hour. BOLD signal will be measured in response to the functional task, the Block span task. | 16 months |
rate of change in loss of neuromelanin in substantia nigra pars compacta | At each study visit NM-MRI, R2\*, T1 MPRAGE, and T2\* weighted blood oxygen level dependent (BOLD) fMRI data will be acquired. The investigators will carry out image processing to determine SNc volume using an automated approach previously shown to have high scan-rescan reproducibility. | 16 months |
Executive function: Tower Of London achievement score | The Delis Kaplan tower of London test is a validated measure of executive function in PD. | 16 months |
Benton's judgment of line orientation task | Judgment of Line Orientation is a standardized test of visuospatial skills commonly associated with functioning of the parietal lobe in the right hemisphere. The test measures a person's ability to match the angle and orientation of lines in space. Subjects are asked to match two angled lines to a set of 11 lines that are arranged in a semicircle and separated 18 degrees from each other. | 16 months |
gait- forward, fast as possible, backward speeds | Objective, spatiotemporal parameters including velocity, stride length, stance percent, velocity variability and other variables of preferred, backward and fast-as-possible walking will be assessed. | 16 months |
attention: Trails Making Test A | Trails making test A is a validated measure of attention and visuospatial processing in people with PD. The time to complete is considered. | 16 months |
spatial imagery: Brooks spatial memory task percent correct | Brooks spatial memory involves reporting back a specified path of numbers that patients are asked to visualize in a 4 x 4 grid. | 16 months |
Age: older than 40 years (40 is upper limit for young onset PD)
Montreal Cognitive Assessment (MoCA) score >17
Able to walk with or without an assistive device at least 10 feet
Best corrected/aided acuity better than 20/70 in the better eye
Willingness to be randomized to either group
H&Y stages I-III
Report OFF times (reporting >0 on item 4.3 of the UPDRS-IV)
Show clear symptomatic benefit from antiparkinsonian medications
- e.g., alleviated rigidity, bradykinesia, and tremor
Fluent in English to comprehend and participate
Untreated Major Depression and major psychiatric illness
History of stroke, or traumatic brain injury
Pure-tone threshold average sensitivity at 0.5, 1.0, and 2.0 kHz exceeds 40 dB
Previous participation in PDAE or WAE classes.
Alcohol abuse and/or use of antipsychotics
Lives outside of the study site or is planning to move out of the area in next year or leave the area for >1 month during the next year
Taking moderate to high doses of beta-blockers with a resting heart rate below 60 beats/min since exercise intensity is measured through target heart rate.
Severe cardiac disease, including:
New York Heart Association (NYHA) Class III or IV congestive heart failure
clinically significant aortic stenosis
history of cardiac arrest, use of a cardiac defibrillator
uncontrolled angina
- as discussed we are not planning to perform routine exercise tolerance tests prior to enrollment
Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention
- e.g. renal failure on hemodialysis, excessive alcohol use (>14 drinks per wk)
Any contraindications to MRI eg claustrophobia, etc
Georgia