Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease

NCT03542474 | Completed Results

• 1 other identifier: STU00202794
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Mean Change in Cognitive Function

  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: * Attention/Working Memory - Trail Making Test-Part A * Executive Function - Trail Making Test-Part B, Clock Draw, Raven's Progressive Matrices * Memory - Hopkin Verbal Learning Test-Revised, Free and Cued Selective Reminding Test, Figural Memory Test * Processing Speed - Symbol Digit Modality Test

  Baseline and 6 Months

Secondary Outcomes (26)

• 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score

  Baseline and 6 Months

• 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Motor Experiences of Daily Living)

  Baseline and 6 Months

• 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Non Motor Experiences of Daily Living Score

  Baseline and 6 Months

• 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Motor Complications Score

  Baseline and 6 Months

• 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Motor (Part III) Score

  Baseline and 6 Months

Study Arms (1)

Exercise

EXPERIMENTAL

6 months of high intensity endurance exercise on a treadmill (3 times per week)

Behavioral: High Intensity Endurance Exercise

Interventions

High Intensity Endurance Exercise BEHAVIORAL

Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months.

Exercise

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Rush University Medical Center: collaborator
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Daniel Corcos
• Organization: Northwestern University

daniel.corcos@northwestern.edu

312-908-6792

Study Officials

• Daniel Corcos, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Jennifer Goldman, MD

  Rush University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy and Human Movement Sciences

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 31, 2018
• Study Start: May 15, 2017
• Primary Completion: November 5, 2018
• Study Completion: August 31, 2019
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)