Parkinson DiseaseNCT03921359
SMARTfit Training for Parkinson's Disease
A study testing SMARTfit training and Conventional physical training in people with Parkinson Disease and Exercise Training, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease, Exercise Training, Cognitive Change
- What is being tested?
- SMARTfit training and Conventional physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2018to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Center for Neurorestoration
Los Angeles, California, 90033
About this study
Official title: Effect of SMARTfit Training on Motor, Cognitive Functions and Brain Connectivity in Individuals With Parkinson's Disease: a Pilot Study
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.
Read the 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.
- Conditions
- Parkinson Disease, Exercise Training, Cognitive Change
- Being tested
- SMARTfit training, Conventional physical training
- Keywords
- Parkinson Disease, Exercise Training, Cognitive function
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTfit trainingBehavioural
For SMARTfit training, participants receive three 1-hour training sessions per week for 8 weeks. During each week, participants will receive physical training focused on six tasks, which are the functional tasks individuals with PD commonly have difficulty with. The six tasks are paired into 3 pairs: (1) sit-to-stand and multi-plane locomotor tasks, (2) gait and reach \& grasp, and (3) floor-to-stand; stand-to-floor and single limb standing. Participants will focus on practicing one pair of tasks during each session. There is an additional cognition component that can be manipulated using features provided by SMARTfit.
Conventional physical trainingBehavioural
For conventional physical training, participants receive three 1-hour training sessions per week for 8 weeks. During each week, participants will receive physical training focused on six tasks, which are the functional tasks individuals with PD commonly have difficulty with. The six tasks are paired into 3 pairs: (1) sit-to-stand and multi-plane locomotor tasks, (2) gait and reach \& grasp, and (3) floor-to-stand; stand-to-floor and single limb standing. Participants will focus on practicing one pair of tasks during each session.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical training | Experimental | Participants assigned to this arm will receive the conventional physical training. Receives: Behavioral: SMARTfit training; Behavioral: Conventional physical training |
| SMARTfit training | Experimental | Participants assigned to this arm will receive the SMARTfit training. Receives: Behavioral: SMARTfit training; Behavioral: Conventional physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-post training change in Modified Physical Performance Test score (mPPT)
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.
Measured: 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 (8)
Pre-post training change in MDS-UPDRS score
The UPDRS is an assessment of Parkinson's disease severity and progress. The UPDRS has four sections. The first section assesses mental, mood, and behavioral changes. The second section assesses historical activities of daily living. The third section is the motor examination portion of the UPDRS and includes evaluations of tremor, rigidity, bradykinesia, gait, and postural instability. The fourth section evaluates complications of therapy including motor fluctuations and dyskinesias. Total score ranges from 0 to 260, with a higher score indicating greater disease severity.
Measured: 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)
The SEE is to capture an individual's confidence in their ability to continue exercising in the face of barriers to exercise. The SEE consists of 9 items describing potential barriers to participation in exercise (e.g., "too busy with other activities," "did not enjoy exercise," "felt pain with exercise," "bored by the exercise"). For each item, participants circled a number from 0 ("not confident") to 10 ("very confident") that best described their belief that they could exercise 3 times a week for 20 minutes. Total score ranges from 0 to 90, with a higher score indicating higher self-efficacy for exercise.
Measured: 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)
The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.
Measured: 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)
The PDCRS is is a valid, reliable and useful neuropsychological battery designed to cover the full spectrum of cognitive defects associated with PD. The PDCRS includes 10 'subcortical-type' items (attention, working memory, Stroop test, four verbal fluencies, immediate and delayed verbal memory, clock drawing), and two 'cortical-type' items (naming, copy of a clock). Total score ranges from 0 to 204, subcortical score from 0 to 174, and cortical score from 0 to 30, with higher scores indicating a better functioning.
Measured: 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 Quotient system test
The Quotient test is an innovative device that objectively measures three domains of cognition: hyperactivity, inattention and impulsivity.
Measured: 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
Participants will receive resting state fMRI, in which they will be instructed to keep their eyes open fixation on a projected image of a white cross on a black background. Participants will also receive task-based fMRI, in which they will be asked to perform a word-color Stroop task.
Measured: 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
A 19-channel EEG acquisition system will be used in recording. Participants will be instructed to sit quietly with eyes closed whilst wearing a skull cap.
Measured: 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
A venous blood sample of up to 40 ml will be obtained from participants.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start19 May 2018
- Primary completion2 Feb 2020
- Study completion16 Mar 2020
Why it stopped: In compliance with research restrictions imposed due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Principal investigator, Charles Liu, University of Southern California
- Investigators
- Charles Liu, MD, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921359
- Sponsor's protocol ID
- HS-17-00928
- Status last verified
- Jul 2020
- First submitted
- 8 Jan 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SMARTfit Training on Motor, Cognitive Functions and Brain Connectivity in Individuals With Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT03921359
- Acronym / sponsor ID
- HS-17-00928
- Conditions
- Parkinson Disease, Exercise Training, Cognitive Change
- Keywords
- Parkinson Disease, Exercise Training, Cognitive function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In compliance with research restrictions imposed due to the COVID-19 pandemic.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 19 May 2018 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physical training | Experimental | Behavioral: SMARTfit training, Behavioral: Conventional physical trainingParticipants assigned to this arm will receive the conventional physical training. |
| SMARTfit training | Experimental | Behavioral: SMARTfit training, Behavioral: Conventional physical trainingParticipants assigned to this arm will receive the SMARTfit training. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMARTfit trainingFor SMARTfit training, participants receive three 1-hour training sessions per week for 8 weeks. During each week, participants will receive physical training focused on six tasks, which are the functional tasks individuals with PD commonly have difficulty with. The six tasks are paired into 3 pairs: (1) sit-to-stand and multi-plane locomotor tasks, (2) gait and reach \& grasp, and (3) floor-to-stand; stand-to-floor and single limb standing. Participants will focus on practicing one pair of tasks during each session. There is an additional cognition component that can be manipulated using features provided by SMARTfit. | Behavioural | Conventional physical training, SMARTfit training |
| Conventional physical trainingFor conventional physical training, participants receive three 1-hour training sessions per week for 8 weeks. During each week, participants will receive physical training focused on six tasks, which are the functional tasks individuals with PD commonly have difficulty with. The six tasks are paired into 3 pairs: (1) sit-to-stand and multi-plane locomotor tasks, (2) gait and reach \& grasp, and (3) floor-to-stand; stand-to-floor and single limb standing. Participants will focus on practicing one pair of tasks during each session. | Behavioural | Conventional physical training, SMARTfit training |
Primary outcome
Pre-post training change in Modified Physical Performance Test score (mPPT)
Time frame: 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.
8 secondary outcomes
Pre-post training change in MDS-UPDRS score
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Quotient system test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study was stopped early (reason given: In compliance with research restrictions imposed due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Liu, MD, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMARTfit training and Conventional physical training in people with Parkinson Disease and Exercise Training, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: In compliance with research restrictions imposed due to the COVID-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-post training change in Modified Physical Performance Test score (mPPT) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.