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SMARTfit Training for Parkinson's Disease

Primary Purpose

Parkinson Disease, Exercise Training, Cognitive Change

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMARTfit training
Conventional physical training
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Exercise Training, Cognitive function

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC Center for Neurorestoration

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional physical training

SMARTfit training

Arm Description

Participants assigned to this arm will receive the conventional physical training.

Participants assigned to this arm will receive the SMARTfit training.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Change in the concentration of α-synuclein and DJ-1
A venous blood sample of up to 40 ml will be obtained from participants.

Full Information

First Posted
January 8, 2019
Last Updated
July 2, 2020
Sponsor
University of Southern California
Collaborators
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT03921359
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
In compliance with research restrictions imposed due to the COVID-19 pandemic.
Study Start Date
May 19, 2018 (Actual)
Primary Completion Date
February 2, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Exercise Training, Cognitive Change
Keywords
Parkinson Disease, Exercise Training, Cognitive function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical training
Arm Type
Experimental
Arm Description
Participants assigned to this arm will receive the conventional physical training.
Arm Title
SMARTfit training
Arm Type
Experimental
Arm Description
Participants assigned to this arm will receive the SMARTfit training.
Intervention Type
Behavioral
Intervention Name(s)
SMARTfit training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional physical training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre-post training change in Modified Physical Performance Test score (mPPT)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Pre-post training change in MDS-UPDRS score
Description
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.
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)
Title
Pre-post training change in Self-Efficacy for Exercise scale (SEES)
Description
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.
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)
Title
Pre-post training change in trail-making test (TMT)
Description
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.
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)
Title
Pre-post training change in Parkinson's Disease-Cognitive Rating Scale (PDCRS)
Description
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.
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)
Title
Pre-post training change in Quotient system test
Description
The Quotient test is an innovative device that objectively measures three domains of cognition: hyperactivity, inattention and impulsivity.
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)
Title
Pre-post training change in functional connectivity
Description
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.
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)
Title
Pre-post training change in EEG delta (2.5-4 Hz) bandpower
Description
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.
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)
Title
Change in the concentration of α-synuclein and DJ-1
Description
A venous blood sample of up to 40 ml will be obtained from participants.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Liu, MD, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Center for Neurorestoration
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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SMARTfit Training for Parkinson's Disease

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