N/A
N=8
Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease
Parkinson Disease · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03542474 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Mean Change in Cognitive Function — -0.6960; -0.6095; 0.6018; 0.6018 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Intensity Endurance Exercise (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Cognitive Function |
-0.6960; -0.6095; 0.6018; 0.6018; -1.657; -1.462 | — |
| SECONDARY 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score |
— | — |
| SECONDARY 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Motor Experiences of Daily Living) |
— | — |
| SECONDARY 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Non Motor Experiences of Daily Living Score |
— | — |
| SECONDARY 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Motor Complications Score |
— | — |
| SECONDARY 6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Motor (Part III) Score |
— | — |
| SECONDARY 6 Month Change in Sleep Quality Evaluated by the Epworth Sleepiness Scale (ESS) |
— | — |
| SECONDARY 6 Month Change in Sleep Quality Evaluated by the Pittsburg Sleep Quality Index (PSQI) |
— | — |
| SECONDARY 6 Month Change in Fatigue Evaluated by the Fatigue Severity Scale |
— | — |
| SECONDARY 6 Month Change in Mood Evaluated by the Hamilton Depression Scale (HAM-D) |
— | — |
| SECONDARY 6 Month Change in Quality of Life Evaluated by the Parkinson Disease Neuro Quality of Life (Neuro-QOL) |
— | — |
| SECONDARY 6 Month Change in Quality of Life Evaluated by the Parkinson Disease Questionnaire 39 (PDQ-39) |
— | — |
| SECONDARY The Boston Naming Test |
— | — |
| SECONDARY Verbal Fluency Test |
— | — |
| SECONDARY Benton Judgement of Line Orientation Test |
— | — |
| SECONDARY Intersecting Pentagon Copying Test |
— | — |
| SECONDARY Mini Balance Evaluation Systems Test |
— | — |
| SECONDARY Timed Up and Go Test (TUG) |
— | — |
| SECONDARY Six Minute Walk Test |
— | — |
| SECONDARY Activities Specific Balance Confidence Scale |
— | — |
| SECONDARY New Freezing of Gait Questionnaire |
— | — |
| SECONDARY 6 Month Change in Hippocampus Volumes on Structural MRI |
— | — |
| SECONDARY 6 Month Change in Microstructural Integrity of White Matter Pathways on Diffusion Tensor Imaging |
— | — |
| SECONDARY 6 Month Change in Functional Connectivity Among Brain Networks on Resting State fMRI |
— | — |
| SECONDARY 6 Month Change in Salivary Cortisol Levels |
13.064; 10.486; 18.996; 15.568; 18.196; 16.29 | — |
| SECONDARY 6 Month Change in Soluble Inflammatory Biomarkers in Plasma |
— | — |
| SECONDARY 6 Month Change in Peripheral Levels of Neurotrophic Factors in Plasma |
— | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT03542474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.