AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

United States1 site
  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

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.

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 groups in NCT03542474
Study groupRoleWhat they receive
ExerciseExperimental6 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.

  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

    Measured: Baseline and 6 Months

Secondary outcomes (26)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Six Minute Walk Test

    Distance traveled during 6 minute walk

    Measured: Baseline and 6 Months

  19. 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

  20. 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

  21. 6 Month Change in Hippocampus Volumes on Structural MRI

    Change in hippocampus volumes on structural MRI

    Measured: Baseline and 6 Months

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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.

  1. First posted31 May 2018
  2. Study start15 May 2017
  3. Primary completion5 Nov 2018
  4. Study completion31 Aug 2019

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in