Clinical trial NCT03542474: Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease
Official title: Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Mild Cognitive Impairment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: Shirley Ryan AbilityLab
First posted: 2018-05-31
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to determine how high intensity endurance exercise affects both cognition and the signs and symptoms of Parkinson's disease as well as if certain brain structures and functions also change with this exercise.

Detailed description: The overall purpose and objective of this project is to test the hypothesis that high intensity endurance exercise causes beneficial brain adaptation in patients with mild cognitive impairment in Parkinson's disease (PD-MCI). Aim 1 will determine the effect of high intensity endurance exercise on cognitive function and other clinical symptoms in PD-MCI. Aim 2 will determine the effect of high intensity endurance exercise on brain structure and function in PD-MCI. Aim 3 will determine the effect of high intensity endurance exercise on cortisol in PD-MCI. Aim 4 will determine the effect of high intensity endurance exercise on inflammation-related biomarkers found in blood in PD-MCI. Aim 5 will determine the effect of high intensity endurance exercise on peripheral levels of neurotrophic factors found in blood in PD-MCI.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change in Cognitive Function
timeFrame: Baseline and 6 Months
Secondary outcomes:
measure: 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Motor Experiences of Daily Living)
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Non Motor Experiences of Daily Living Score
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Motor Complications Score
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Motor (Part III) Score
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Sleep Quality Evaluated by the Epworth Sleepiness Scale (ESS)
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Sleep Quality Evaluated by the Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Fatigue Evaluated by the Fatigue Severity Scale
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Mood Evaluated by the Hamilton Depression Scale (HAM-D)
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Quality of Life Evaluated by the Parkinson Disease Neuro Quality of Life (Neuro-QOL)
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Quality of Life Evaluated by the Parkinson Disease Questionnaire 39 (PDQ-39)
timeFrame: Baseline and 6 Months
measure: The Boston Naming Test
timeFrame: Baseline and 6 Months
measure: Verbal Fluency Test
timeFrame: Baseline and 6 Months
measure: Benton Judgement of Line Orientation Test
timeFrame: Baseline and 6 Months
measure: Intersecting Pentagon Copying Test
timeFrame: Baseline and 6 Months
measure: Mini Balance Evaluation Systems Test
timeFrame: Baseline and 6 Months
measure: Timed Up and Go Test (TUG)
timeFrame: Baseline and 6 Months
measure: Six Minute Walk Test
timeFrame: Baseline and 6 Months
measure: Activities Specific Balance Confidence Scale
timeFrame: Baseline and 6 Months
measure: New Freezing of Gait Questionnaire
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Hippocampus Volumes on Structural MRI
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Microstructural Integrity of White Matter Pathways on Diffusion Tensor Imaging
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Functional Connectivity Among Brain Networks on Resting State fMRI
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Salivary Cortisol Levels
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Soluble Inflammatory Biomarkers in Plasma
timeFrame: Baseline and 6 Months
measure: 6 Month Change in Peripheral Levels of Neurotrophic Factors in Plasma
timeFrame: Baseline and 6 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Daniel Corcos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University
name: Jennifer Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References: