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| Name | Class |
|---|---|
| Rush University Medical Center | OTHER |
| Shirley Ryan AbilityLab | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | 6 months of high intensity endurance exercise on a treadmill (3 times per week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Baseline and 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Corcos, PhD | Northwestern University | Principal Investigator |
| Jennifer Goldman, MD | Rush University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | 6 months of high intensity endurance exercise on a treadmill (3 times per week) High Intensity Endurance Exercise: Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | 6 months of high intensity endurance exercise on a treadmill (3 times per week) High Intensity Endurance Exercise: Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Raw scores for cognitive tests were transformed to Z-scores based upon normative data. Cognitive domain scores were calculated by averaging Z-scores for neuropsychological tests within specific domains, thereby accounting for any unequal distribution of tests per domain. Higher (more positive) scores indicate better outcome. | Posted | Mean | Standard Deviation | z-score | Baseline and 6 Months |
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | 6 months of high intensity endurance exercise on a treadmill (3 times per week) High Intensity Endurance Exercise: Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Corcos | Northwestern University | 312-908-6792 | daniel.corcos@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2019 | Jun 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | Baseline and 6 Months |
| Mini Balance Evaluation Systems Test | Measure of dynamic balance, scores range from 0 (no Balance) to 28 good dynamic balance | 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 | Baseline and 6 Months |
| Six Minute Walk Test | Distance traveled during 6 minute walk | 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) | 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. | Baseline and 6 Months |
| 6 Month Change in Hippocampus Volumes on Structural MRI | Change in hippocampus volumes on structural MRI | 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 | 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 | 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). | 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 | 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 | Baseline and 6 Months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| 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 | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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). | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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 | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | Mini Balance Evaluation Systems Test | Measure of dynamic balance, scores range from 0 (no Balance) to 28 good dynamic balance | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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 | Not Posted | Baseline and 6 Months | Participants |
| Secondary | Six Minute Walk Test | Distance traveled during 6 minute walk | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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) | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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. | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 6 Month Change in Hippocampus Volumes on Structural MRI | Change in hippocampus volumes on structural MRI | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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 | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 6 Month Change in Functional Connectivity Among Brain Networks on Resting State fMRI | Change in Functional connectivity among brain networks on resting state fMRI | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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). | Posted | Mean | Standard Error | nmol/l | Baseline and 6 Months |
|
|
|
| Secondary | 6 Month Change in Soluble Inflammatory Biomarkers in Plasma | Change in soluble inflammatory biomarkers in plasma between baseline and 6 months post exercise | Not Posted | Baseline and 6 Months | Participants |
| Secondary | 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 | Not Posted | Baseline and 6 Months | Participants |
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| Back pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Outpatient surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Hip Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| 0.25 Post |
|
| 0.5 Pre |
|
| 0.5 Post |
|
| 0.75 Pre |
|
| 0.75 Post |
|
| 3 Pre |
|
| 3 Post |
|
| 6 Pre |
|
| 6 Post |
|
| 9 Pre |
|
| 9 Post |
|
| 12 Pre |
|
| 12 Post |
|