Effect of SMARTfit Training on Motor, Cognitive Functions and Brain Connectivity in Individuals With Parkinson's Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Pre-post training change in Modified Physical Performance Test score (mPPT)
研究概览
简要总结
This pilot study aims to investigate the effects of 8-week SMARTfit training versus conventional physical training on motor function, cognition and brain functional connectivity in individuals with PD. The investigators hypothesize that clinical and physical performance will improve after SMARTfit training more than after conventional physical training.
详细描述
Although Parkinson's disease (PD) has been mainly viewed as a movement disorder, the pathophysiology of declined motor function incorporates impairments of multiple systems, including sensory, motor and cognitive pathways. Specifically, it has been demonstrated that cognitive function may play an essential role in motor function for individuals with PD. Cognitive dysfunction involving set-shifting and attentional control has been found to be associated with movement slowness in performing a finger sequence task and freezing of gait. Furthermore, a recent rodent model indicates that cognitive dysfunction may occur prior to the onset of motor symptoms. Similarly human studies show that 25-30% individuals with PD exhibit cognitive impairments at the time of diagnosis. The overall evidence suggests that cognitive dysfunction may contribute to degraded motor function in PD. Interestingly, several studies demonstrate that aerobic exercise and resistance training can improve cognitive function in individuals with PD, indicating a tight interplay between motor and cognitive function. Targeting cognitive function by incorporating cognitive training into physical rehabilitation may be important for people with PD. Although there is mounting evidence for the benefits of physical exercise in PD, few studies investigate whether combining cognitive training with physical exercise can provide additional benefits than physical exercise alone. Thus, the purpose of this pilot study is to investigate the effect of SMARTfit training, a novel technology that provides an opportunity to combine physical training with cognitive training, in individuals with PD. The hypothesis is that SMARTfit training will promote greater motor and cognition improvements than conventional physical training. To test the above hypothesis, ten individuals with mild PD will receive both SMARTfit training and conventional physical training in a counterbalanced order with a washout period. For each training program, participants will receive a 1-hour training session 3 times per week for 8 weeks. The changes in disease biomarkers before and after training will also be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-85 years of age
- •Diagnosis of idiopathic Parkinson's disease using the UK Brain Bank criteria (as determined by the study movement disorders neurologist) with Hoehn and Yahr stage 1-2
- •No contraindications to exercise including untreated cardiovascular disease or stroke
- •Medically stable and optimized on their medications
- •Able to ambulate independently with or without device
- •No other neurologic, neuromuscular, or orthopedic disease
- •No serious cognitive deficits and able to participate in the informed consent process
- •With medical clearance from primary care physician to participate in the physical therapy intervention
- •No contraindications for MRI
排除标准
- •Severe cardiac disease (New York Heart Association classification II-IV)
- •Systolic blood pressure reduction of greater than 20 mmHg with standing
- •A history of poorly controlled or brittle diabetes
- •A history of lower limb amputation
- •Been prescribed any new dopamine replacement medications or new mood stabilizer medications.
- •Presence of a lower limb non-healing ulcer
- •Montreal cognitive assessment score of less than 21
- •The presence of any medical condition which the investigator believes might present an unacceptable health risk to the subject should they participate in the study
- •Electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
- •Metal in any part of the body including metal injury to the eye
- •History of brain lesions (such as stroke), seizures, or unexplained spells of loss of consciousness
- •Pregnant or breast-feeding
- •With other neurologic, neuromuscular, or orthopedic disease that would interfere with ability to participate in exercise training
- •Currently participating in other studies
结局指标
主要结局
Pre-post training change in Modified Physical Performance Test score (mPPT)
时间窗: pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks)
The mPPT is a 9-item test that assesses multiple dimensions of physical function (basic and complex activities of daily living) with different levels of difficulty. Participants will be asked to complete functional tasks (i.e. writing a sentence, simulated eating, lift a book and put it on a shelf, turning 360 degrees, 50-foot walking test, stair climbing etc.). Total score ranges from 0 to 36, with a higher score indicating better physical function.
次要结局
- Pre-post training change in Quotient system test(pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks))
- Pre-post training change in functional connectivity(pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks))
- Pre-post training change in MDS-UPDRS score(pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks))
- Pre-post training change in Self-Efficacy for Exercise scale (SEES)(pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks))
- Pre-post training change in EEG delta (2.5-4 Hz) bandpower(pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks))
- Change in the concentration of α-synuclein and DJ-1(pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks))
- Pre-post training change in Parkinson's Disease-Cognitive Rating Scale (PDCRS)(pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks))
- Pre-post training change in trail-making test (TMT)(pre-assessment 1 (baseline), post-assessment 1 (8 weeks), pre-assessment 2 (after 2-month washout period after post-assessment 1, 16 weeks), post-assessment 2 (24 weeks))
研究者
Charles Liu
Professor of Clinical Neurological Surgery
University of Southern California