- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542474
Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female, ages 40-85
- A diagnosis of idiopathic PD
- A diagnosis of PD-MCI
- Due to the stringent head motion during fMRI, we will only include a patient with a head tremor of < 2.
- Hoehn and Yahr stage < or equal to 3
- Stable medication regimen for > or equal to 30 days before entering the study
- Living with a carepartner
Exclusion Criteria:
- PD subjects meeting MDS criteria for PD dementia or having a SCOPA-Cog score less than or equal to 16, or PD subjects having normal cognition defined as a SCOPA-Cog Score of is greater or equal to 25.
- Atypical or secondary parkinsonism as determined by referring Neurologist
- Other disorders that might interfere with ability to perform high intensity endurance exercise (e.g. history of stroke, respiratory problems, traumatic brain injury, known advanced osteoarthritis, or neuromuscular disease).
- Individuals with known injury, disease, or condition that would affect the ability to perform endurance exercise.
- Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse that would, in the judgment of the investigator, interfere with the subject's ability to participate in the study.
- "Vigorous athletes" participating in any exercise program 2X/week or more will be excluded.
- Individuals with any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip (i.e., an ° Persons who have had a long history of working in metal shops will be excluded unless they have had a previous orbital x-ray scan clearing them for participation in MRI studies.
- Females who are pregnant or might be pregnant will be excluded from participation.
- Individuals who are claustrophobic and unable to tolerate a brain MRI scan will be excluded.
- Treatment with cholinesterase inhibitors or memantine (i.e., medications approved for treatment of dementia) or medications affecting cognition (i.e., anticholinergics)
- Use of medications that might interfere with neuromuscular junction function such as D-penicillamine and aminoglycoside antibiotics.
- Use of medications that might interfere with the BOLD contrast or heart response to exercise (e.g. β blockers).
- Individuals at high risk for cardiovascular disease as defined in Table 2.2 by the new ACSM guidelines.(Medicine 2014)
- Younger than 40 and older than 85. We exclude participants younger than 40 because these young onset patients may not be typical of the majority of patients who get the disease later in life. We exclude participants older than 85 because of the limited evidence they can successfully complete a high-intensity endurance exercise program. We also exclude patients whose disease was diagnosed before the age of 40.
- Individuals with known endocrine abnormalities or steroid use that could affect cortisol levels (e.g., Cushing's syndrome, pituitary or adrenal gland disease or adrenalectomy, use of steroid-based medications.
- Individuals with strong history of chronic inflammatory or autoimmune diseases or history of chronic use of NSAIDs, which could cause abnormal levels of inflammatory markers in the plasma.
- We will exclude adults unable to consent, individuals who are not yet adults, pregnant women, prisoners and children from this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Exercise
6 months of high intensity endurance exercise on a treadmill (3 times per week)
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Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Cognitive Function
Time Frame: Baseline and 6 Months
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Mean change in cognitive function from baseline to 6-months as measured by global statistical test (GST) for cognitive domains. This will be a composite score reported as Z-scores. The Z-score indicates the number of standard deviations away from the mean, which is based on normative (healthy control) data. A Z-score of 0 is equal to the mean of the normative data with negative numbers indicating values lower than the mean and positive values higher. A positive change in Z-scores indicates a favorable outcome. The GSTs will be calculated from the following neuropsychological tests administered in the cognitive test battery reflecting specific cognitive domains:
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Baseline and 6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Time Frame: Baseline and 6 Months
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Mean change in total MDS-UPDRS score.
This is a summed total from Part I (non-motor experiences of daily living), Part II (motor experiences of daily living, Part III (motor examination) and Part IV (motor complications).
The minimum score on the MDS-UPDRS is 0 and the maximum is 260 with higher scores representing worse symptoms.
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Baseline and 6 Months
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6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Motor Experiences of Daily Living)
Time Frame: Baseline and 6 Months
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Mean change in total MDS-UPDRS Part II (motor experiences of daily living) score.
Part II comprises 13 items evaluating the impact of PD on patients' activities of daily living (ADL) over the week prior to the visit such as speech, salivation, swallowing, eating, handwriting, dressing, turning in bed, walking.
The total score, being the sum of all these items, can be between 0 to 52.
Higher scores represent worse symptoms.
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Baseline and 6 Months
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6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Non Motor Experiences of Daily Living Score
Time Frame: Baseline and 6 Months
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Mean change in total MDS-UPDRS Part I (non-motor experiences of daily living) score.
Part I assesses 15 items of non-motor aspects of experiences of daily living.
Part IA is assessed by a qualified rater, Part IB is completed by the patient.
The total score, being the sum of all these items, can be between 0 to 60. Higher scores represent worse symptoms.
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Baseline and 6 Months
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6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Motor Complications Score
Time Frame: Baseline and 6 Months
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Mean change in total MDS-UPDRS Part IV (motor complications) score.
Part IV assesses motor complications of therapy, such as dyskinesias, motor fluctuations.
This part (6 items) is completed by a qualified rater.
The total score, being the sum of all these items, can be between 0 to 24.
Higher scores represent worse symptoms.
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Baseline and 6 Months
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6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Motor (Part III) Score
Time Frame: Baseline and 6 Months
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Mean change in total MDS-UPDRS Part III (motor examination) score.
The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms.
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Baseline and 6 Months
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6 Month Change in Sleep Quality Evaluated by the Epworth Sleepiness Scale (ESS)
Time Frame: Baseline and 6 Months
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The ESS assesses the overall level of daytime sleepiness.
Eight items describe normative daily situations known to vary in their soporific qualities.
Patients rate the likelihood of dozing off or falling asleep.
The test is rated on a 4-point scale (0=would never doze off to 3=high chance of dozing off).
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Baseline and 6 Months
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6 Month Change in Sleep Quality Evaluated by the Pittsburg Sleep Quality Index (PSQI)
Time Frame: Baseline and 6 Months
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The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available).
Only self-rated questions are included in the scoring.
The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points.The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
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Baseline and 6 Months
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6 Month Change in Fatigue Evaluated by the Fatigue Severity Scale
Time Frame: Baseline and 6 Months
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A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale.
The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.
The minimum score = 9 and maximum score possible = 63.
Higher the score = greater fatigue severity.
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Baseline and 6 Months
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6 Month Change in Mood Evaluated by the Hamilton Depression Scale (HAM-D)
Time Frame: Baseline and 6 Months
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Although the HAM-D form lists 21 items, the scoring is based on the first 17.
Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe.
Nine are scored from 0-2.
Higher scores represent more severe depression.
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Baseline and 6 Months
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6 Month Change in Quality of Life Evaluated by the Parkinson Disease Neuro Quality of Life (Neuro-QOL)
Time Frame: Baseline and 6 Months
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The NeuroQOL is a self-report of health related quality of life in 17 domains and sub-domains for adults.
Item banks consist of 302 items in total (range from 5 to 45) which are used adaptively to test a variable number and content of items in a computer assisted testing format.
All items are rated on a five option scale based on intensity (e.g. 1 = not at all, 2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = very much) or frequency ("never" to "always").
Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10.
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Baseline and 6 Months
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6 Month Change in Quality of Life Evaluated by the Parkinson Disease Questionnaire 39 (PDQ-39)
Time Frame: Baseline and 6 Months
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The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month covering 8 dimensions 1) Mobility (10, #1-10) 2) Activities of daily living (ADL) (6, #11-16) 3) Emotional well-being (6, #17-22) 4) Stigma (4, #23-26) 5) Social support (3, #27-29) 6) Cognition (4, #30-33) 7) Communication (3, #34-36) 8) Bodily discomfort (3, #37-39) on a 5 point ordinal system (0=never, 4=always).
Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100.
Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
Lower scores reflect better QoL.
Overall score can be summarized in the Parkinson's Disease Summary Index (PDSI) or PDQ-39 Summary Index (PDQ-39 SI).PDSI or PDQ-39 SI = sum of dimension total scores divided by 8.
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Baseline and 6 Months
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The Boston Naming Test
Time Frame: Baseline and 6 Months
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The examiner begins with Item 1 and continues through Item 60, unless the patient is in distress or refuses to continue.
The patient is told to tell the examiner the name of each picture and is given about 20 seconds to respond for each trial.
The examiner writes down the patient's responses in detail, using codes.
If the patient fails to give the correct response, the examiner at her or his discretion may give the patient a phonemic cue, which is the initial sound of the target word.
After the patient completes the test, the examiner scores each item + or - according to the response coding and scoring procedures.
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Baseline and 6 Months
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Verbal Fluency Test
Time Frame: Baseline and 6 Months
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The Verbal Fluency Test has two conditions, Letter Verbal Fluency and Category Verbal Fluency.
Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds, the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds.
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Baseline and 6 Months
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Benton Judgement of Line Orientation Test
Time Frame: Baseline and 6 Months
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Benton Judgment of Line Orientation Test is a standardized test with 30 items that is specific for visual spatial cognition. Tests will be administered at baseline, after 3, 6, 9 and 12 months of treatment. The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition |
Baseline and 6 Months
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Intersecting Pentagon Copying Test
Time Frame: Baseline and 6 Months
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This involves the participant copying an intersecting double pentagon and is given a maximum score of 1 point based on the correctness of copying.
The IPC addresses visuospatial constructional skills and executive function.
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Baseline and 6 Months
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Mini Balance Evaluation Systems Test
Time Frame: Baseline and 6 Months
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Measure of dynamic balance, scores range from 0 (no Balance) to 28 good dynamic balance
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Baseline and 6 Months
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Timed Up and Go Test (TUG)
Time Frame: Baseline and 6 Months
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This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again
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Baseline and 6 Months
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Six Minute Walk Test
Time Frame: Baseline and 6 Months
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Distance traveled during 6 minute walk
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Baseline and 6 Months
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Activities Specific Balance Confidence Scale
Time Frame: Baseline and 6 Months
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The activities specific balance confidence scale is used to assess the level of fear of falling.
It consists of 16 items reflecting the level of balance confidence from 0% (no confidence) to 100% (complete confidence)
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Baseline and 6 Months
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New Freezing of Gait Questionnaire
Time Frame: Baseline and 6 Months
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The New Freezing of Gait Questionnaire (NFOG-Q) is a clinician-administered tool that aims to assess both the clinical aspects of FOG as well as its subsequent impairments on quality of life.
The task ratings and scales are calculated into a summed NFOG-Q score.
Part I detected the presence of FOG using a dichotomous item in which individuals were classified as a freezer (FR) or a non-freezer (NFR) if they had experienced FOG-episodes during the past month.
Parts II and III were designed for FRs only, providing a total summed score between 0 and 28.
Part II (items 2-6, scoring range 0-19) rated the severity of FOG based on its duration and frequency in its most common manifestation, i.e. during turning and initiation of gait.
Part III rated the impact of FOG on daily life (items 7-9, scoring range 0-9).
No separate on and off rating of parts II and III was considered to avoid unreliable assessment.
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Baseline and 6 Months
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6 Month Change in Hippocampus Volumes on Structural MRI
Time Frame: Baseline and 6 Months
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Change in hippocampus volumes on structural MRI
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Baseline and 6 Months
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6 Month Change in Microstructural Integrity of White Matter Pathways on Diffusion Tensor Imaging
Time Frame: Baseline and 6 Months
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Change in Microstructural integrity of white matter pathways on diffusion tensor imaging
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Baseline and 6 Months
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6 Month Change in Functional Connectivity Among Brain Networks on Resting State fMRI
Time Frame: Baseline and 6 Months
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Change in Functional connectivity among brain networks on resting state fMRI
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Baseline and 6 Months
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6 Month Change in Salivary Cortisol Levels
Time Frame: Baseline and 6 Months
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Change in salivary cortisol levels between baseline and 6 months post exercise.
Cortisol samples were taken before the exercise intervention (Pre) and after the exercise intervention (Post) at 8 different time points: At awakening (0), 15 minutes post awakening (0.25), 30 minutes post awakening (0.5), 45 minutes post awakening (0.75), 3 hours post awakening (3), 6 hours post awakening (6), 9 hours post awakening (9), and 12 hours post awakening (12).
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Baseline and 6 Months
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6 Month Change in Soluble Inflammatory Biomarkers in Plasma
Time Frame: Baseline and 6 Months
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Change in soluble inflammatory biomarkers in plasma between baseline and 6 months post exercise
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Baseline and 6 Months
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6 Month Change in Peripheral Levels of Neurotrophic Factors in Plasma
Time Frame: Baseline and 6 Months
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Change in peripheral levels of neurotrophic factors in plasma between baseline and 6 months post exercise
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Baseline and 6 Months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Corcos, PhD, Northwestern University
- Principal Investigator: Jennifer Goldman, MD, Rush University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00202794
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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