Parkinson DiseaseNCT03542474
Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease
A study testing High Intensity Endurance Exercise in people with Parkinson Disease and Mild Cognitive Impairment, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment
- What is being tested?
- High Intensity Endurance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Being tested
- High Intensity Endurance Exercise
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Endurance ExerciseBehavioural
Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 6 months of high intensity endurance exercise on a treadmill (3 times per week) Receives: Behavioral: High Intensity Endurance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 Months
Secondary outcomes (26)
6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Baseline and 6 Months
6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Motor Complications Score
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.
Measured: Baseline and 6 Months
6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Motor (Part III) Score
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.
Measured: Baseline and 6 Months
6 Month Change in Sleep Quality Evaluated by the Epworth Sleepiness Scale (ESS)
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).
Measured: Baseline and 6 Months
6 Month Change in Sleep Quality Evaluated by the Pittsburg Sleep Quality Index (PSQI)
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.
Measured: Baseline and 6 Months
6 Month Change in Fatigue Evaluated by the Fatigue Severity Scale
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.
Measured: Baseline and 6 Months
6 Month Change in Mood Evaluated by the Hamilton Depression Scale (HAM-D)
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.
Measured: Baseline and 6 Months
6 Month Change in Quality of Life Evaluated by the Parkinson Disease Neuro Quality of Life (Neuro-QOL)
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.
Measured: Baseline and 6 Months
6 Month Change in Quality of Life Evaluated by the Parkinson Disease Questionnaire 39 (PDQ-39)
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.
Measured: Baseline and 6 Months
The Boston Naming Test
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.
Measured: Baseline and 6 Months
Verbal Fluency Test
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.
Measured: Baseline and 6 Months
Benton Judgement of Line Orientation Test
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
Measured: Baseline and 6 Months
Intersecting Pentagon Copying Test
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.
Measured: Baseline and 6 Months
Mini Balance Evaluation Systems Test
Measure of dynamic balance, scores range from 0 (no Balance) to 28 good dynamic balance
Measured: Baseline and 6 Months
Timed Up and Go Test (TUG)
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
Measured: Baseline and 6 Months
Six Minute Walk Test
Distance traveled during 6 minute walk
Measured: Baseline and 6 Months
Activities Specific Balance Confidence Scale
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)
Measured: Baseline and 6 Months
New Freezing of Gait Questionnaire
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.
Measured: Baseline and 6 Months
6 Month Change in Hippocampus Volumes on Structural MRI
Change in hippocampus volumes on structural MRI
Measured: Baseline and 6 Months
6 Month Change in Microstructural Integrity of White Matter Pathways on Diffusion Tensor Imaging
Change in Microstructural integrity of white matter pathways on diffusion tensor imaging
Measured: Baseline and 6 Months
6 Month Change in Functional Connectivity Among Brain Networks on Resting State fMRI
Change in Functional connectivity among brain networks on resting state fMRI
Measured: Baseline and 6 Months
6 Month Change in Salivary Cortisol Levels
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).
Measured: Baseline and 6 Months
6 Month Change in Soluble Inflammatory Biomarkers in Plasma
Change in soluble inflammatory biomarkers in plasma between baseline and 6 months post exercise
Measured: Baseline and 6 Months
6 Month Change in Peripheral Levels of Neurotrophic Factors in Plasma
Change in peripheral levels of neurotrophic factors in plasma between baseline and 6 months post exercise
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start15 May 2017
- Primary completion5 Nov 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, Shirley Ryan AbilityLab
- Responsible party
- Principal investigator, Daniel Corcos, Northwestern University
- Investigators
- Daniel Corcos, PhD, Principal investigator, Northwestern UniversityJennifer Goldman, MD, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542474
- Sponsor's protocol ID
- STU00202794
- Status last verified
- Jun 2020
- First submitted
- 16 Apr 2018
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03542474
- Acronym / sponsor ID
- STU00202794
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Rush University Medical Center, Shirley Ryan AbilityLab
- Study start
- 15 May 2017 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: High Intensity Endurance Exercise6 months of high intensity endurance exercise on a treadmill (3 times per week) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Endurance ExerciseTreadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months. | Behavioural | Exercise |
Primary outcome
Mean Change in Cognitive Function
Time frame: Baseline and 6 Months
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
26 secondary outcomes
6 Month Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Time frame: 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)
Time frame: 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
Time frame: Baseline and 6 Months
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
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
6 Month Change in Sleep Quality Evaluated by the Epworth Sleepiness Scale (ESS)
Time frame: Baseline and 6 Months
6 Month Change in Sleep Quality Evaluated by the Pittsburg Sleep Quality Index (PSQI)
Time frame: Baseline and 6 Months
6 Month Change in Fatigue Evaluated by the Fatigue Severity Scale
Time frame: Baseline and 6 Months
6 Month Change in Mood Evaluated by the Hamilton Depression Scale (HAM-D)
Time frame: Baseline and 6 Months
6 Month Change in Quality of Life Evaluated by the Parkinson Disease Neuro Quality of Life (Neuro-QOL)
Time frame: Baseline and 6 Months
6 Month Change in Quality of Life Evaluated by the Parkinson Disease Questionnaire 39 (PDQ-39)
Time frame: Baseline and 6 Months
The Boston Naming Test
Time frame: Baseline and 6 Months
Verbal Fluency Test
Time frame: Baseline and 6 Months
Benton Judgement of Line Orientation Test
Time frame: Baseline and 6 Months
Intersecting Pentagon Copying Test
Time frame: Baseline and 6 Months
Mini Balance Evaluation Systems Test
Time frame: Baseline and 6 Months
Timed Up and Go Test (TUG)
Time frame: Baseline and 6 Months
Six Minute Walk Test
Time frame: Baseline and 6 Months
Activities Specific Balance Confidence Scale
Time frame: Baseline and 6 Months
New Freezing of Gait Questionnaire
Time frame: Baseline and 6 Months
6 Month Change in Hippocampus Volumes on Structural MRI
Time frame: Baseline and 6 Months
6 Month Change in Microstructural Integrity of White Matter Pathways on Diffusion Tensor Imaging
Time frame: Baseline and 6 Months
6 Month Change in Functional Connectivity Among Brain Networks on Resting State fMRI
Time frame: Baseline and 6 Months
6 Month Change in Salivary Cortisol Levels
Time frame: Baseline and 6 Months
6 Month Change in Soluble Inflammatory Biomarkers in Plasma
Time frame: Baseline and 6 Months
6 Month Change in Peripheral Levels of Neurotrophic Factors in Plasma
Time frame: Baseline and 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Corcos, PhD principal investigator
Northwestern University
Jennifer Goldman, MD principal investigator
Rush University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Endurance Exercise in people with Parkinson Disease and Mild Cognitive Impairment, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Cognitive Function (time frame: Baseline and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.