Clinical trial NCT03921359: SMARTfit Training for Parkinson's Disease
Official title: Effect of SMARTfit Training on Motor, Cognitive Functions and Brain Connectivity in Individuals With Parkinson's Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Exercise Training
Cognitive Change
Keywords: Parkinson Disease
Exercise Training
Cognitive function
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
First posted: 2019-04-19
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 50-85 years of age
2. 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
3. No contraindications to exercise including untreated cardiovascular disease or stroke
4. Medically stable and optimized on their medications
5. Able to ambulate independently with or without device
6. No other neurologic, neuromuscular, or orthopedic disease
7. No serious cognitive deficits and able to participate in the informed consent process
8. With medical clearance from primary care physician to participate in the physical therapy intervention
9. No contraindications for MRI

Exclusion Criteria:

1. Severe cardiac disease (New York Heart Association classification II-IV)
2. Systolic blood pressure reduction of greater than 20 mmHg with standing
3. A history of poorly controlled or brittle diabetes
4. A history of lower limb amputation
5. Been prescribed any new dopamine replacement medications or new mood stabilizer medications.
6. Presence of a lower limb non-healing ulcer
7. Montreal cognitive assessment score of less than 21
8. 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
9. Electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
10. Metal in any part of the body including metal injury to the eye
11. History of brain lesions (such as stroke), seizures, or unexplained spells of loss of consciousness
12. Pregnant or breast-feeding
13. With other neurologic, neuromuscular, or orthopedic disease that would interfere with ability to participate in exercise training
14. Currently participating in other studies

Primary outcomes:
measure: Pre-post training change in Modified Physical Performance Test score (mPPT)
timeFrame: 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)
Secondary outcomes:
measure: Pre-post training change in MDS-UPDRS score
timeFrame: 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)
measure: Pre-post training change in Self-Efficacy for Exercise scale (SEES)
timeFrame: 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)
measure: Pre-post training change in trail-making test (TMT)
timeFrame: 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)
measure: Pre-post training change in Parkinson's Disease-Cognitive Rating Scale (PDCRS)
timeFrame: 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)
measure: Pre-post training change in Quotient system test
timeFrame: 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)
measure: Pre-post training change in functional connectivity
timeFrame: 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)
measure: Pre-post training change in EEG delta (2.5-4 Hz) bandpower
timeFrame: 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)
measure: Change in the concentration of α-synuclein and DJ-1
timeFrame: 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)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Center for Neurorestoration
state: California
Study officials:
affiliation: University of Southern California
name: Charles Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: