Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2R01NS073717-06A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| University of Utah | OTHER |
Not provided
Not provided
Not provided
Not provided
Identification of an effective disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral) is an unmet need in Parkinson's disease (PD). Increasing evidence indicates high intensity aerobic exercise is a candidate to alter PD progression. The primary aim of this study is to examine the disease-altering capabilities of a long-term, high-intensity aerobic exercise intervention. A multi-site pragmatic randomized controlled trial design has been selected. Individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive an indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Motor and non-motor assessments will be conducted at the main campus of the Cleveland Clinic or the University of Utah at enrollment, 6 months, and 12 months. Each assessment will last approximately one hour.
Overview of Experimental Design: The study is a randomized controlled clinical trial designed to examine the disease-altering capabilities of a 12 month aerobic exercise program for individuals with PD. A total of 252 individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive a commercially available Peloton indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Both groups will undergo a series of motor and non-motor assessments at enrollment, 6 months, and 12 months to measure disease progression of the 12 month period. Additionally, data will be used to develop a prognostic model to predict 12-month change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) for patients participating in a home-based high-intensity aerobic exercise program.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Exercise Group | Experimental | Mild to moderate Parkinson's disease patients: The exercise group will be asked to cycle 3x/week for 12 months on a Peloton bicycle which will be delivered to their home. |
|
| Usual and Customary Care Group | Other | Mild to moderate Parkinson's disease patients, receiving no exercise intervention through the research but monitored with a parallel attention control. They will continue to receive usual and customary care for their Parkinson's disease during the 12 month period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Aerobic Exercise (AE) | Other | The home-based exercise group will have a Peloton indoor cycle, heart rate monitor strap, and Garmin activity monitor to track daily activity levels delivered to the home. Participants will be asked to cycle 3x/week for 12 months on this bike with heart rate monitor at aerobic intensity 60-80% of heart rate reserve and target cadence 80-90 revolutions per minute. Study team members will telephone all participants biweekly for similar contact times between treatment groups. During these calls, a study team member reviews fall diary information, inquires about possible adverse events, and reviews participants' activity monitor wear times on the Garmin Connect website (https://connect.garmin.com). For those in the AE group, exercise recommendations, e.g., increase duration, cadence or heart rate, are given based on review of exercise session data on the Peloton portal (onepeloton.com). Compliance barriers or technical challenges with the activity monitor or exercise cycle are addressed. |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meter Walk Test (10MWT) Comfortable Pace Velocity | The 10 Meter Walk Test (10MWT) evaluates gait speed similarly in separate trials with the participant instructed to walk at comfortable and fast pace, and velocity timed over the middle six meters. This outcome is the velocity (meters/second) with instructions to walk at a comfortable pace, performed off medication. Higher velocities indicate better motor function. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jay L Alberts, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| University of Utah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25046650 | Background | Rudick RA, Miller D, Bethoux F, Rao SM, Lee JC, Stough D, Reece C, Schindler D, Mamone B, Alberts J. The Multiple Sclerosis Performance Test (MSPT): an iPad-based disability assessment tool. J Vis Exp. 2014 Jun 30;(88):e51318. doi: 10.3791/51318. | |
| 31054035 | Background | Rhodes JK, Schindler D, Rao SM, Venegas F, Bruzik ET, Gabel W, Williams JR, Phillips GA, Mullen CC, Freiburger JL, Mourany L, Reece C, Miller DM, Bethoux F, Bermel RA, Krupp LB, Mowry EM, Alberts J, Rudick RA. Multiple Sclerosis Performance Test: Technical Development and Usability. Adv Ther. 2019 Jul;36(7):1741-1755. doi: 10.1007/s12325-019-00958-x. Epub 2019 May 3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aerobic Exercise Group | Aerobic Exercise on a Stationary Bike |
| FG001 | Usual and Customary Care Group | Continue regular activity. No aerobic exercise intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Mild to moderate Parkinson's disease patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High-Intensity Aerobic Exercise Group | Mild to moderate Parkinson's disease patients receiving a Peloton indoor cycle and a heart rate monitor strap delivered to the home, and asked to cycle 3x/week for 12 months with goal of progressing to 45 minute sessions with the heart rate monitor at an aerobic intensity between 60-80% of heart rate reserve with a target cadence between 80-90 revolutions per minute (RPMs). Participants also receive and are asked to wear activity monitors throughout the day to monitor daily. activity levels. Participants also receive biweekly telephone calls to review electronic activity monitoring and exercise data, monitor falls and adverse events, and for guidance on progressing their cycling exercise sessions. See Alberts JL et al., Physical Therapy, 2021;101:1-10. |
| 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 | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. | Means and standard deviations are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic modeling results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 6 months, 12 months |
|
12 Months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aerobic Exercise Group | Aerobic Exercise on a Stationary Bike | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay L. Alberts | The Cleveland Clinic Foundation | 440-708-3735 | albertj@ccf.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 9, 2021 | Apr 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2024 | Apr 7, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 28, 2021 | Mar 31, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
252 mild to moderate PD patients will be randomized into a home cycling high-intensity aerobic exercise (AE) group or a Usual and Customary Care (UCC) group, asked to continue normal activity level and not initiate a formal cycling program during study participation.
Not provided
Not provided
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) will be conducted by a consistent rater, blinded as to participant randomization group.
|
| Usual and Customary Care (UCC) | Other | Participants in this group will continue to receive their usual care. They will also receive activity monitors to monitor their daily activity levels, and telephone monitoring throughout the study. Study team members telephone all participants every 2 weeks for similar amounts of contact time between treatment groups. During the calls, a study team member of the reviews fall diary information, inquires about possible adverse events, and reviews participants' activity monitor wear times via the Garmin Connect website (https://connect.garmin.com). |
|
| Baseline, 6 months, 12 months |
| 10 Meter Walk Test (10MWT) Fast Pace Velocity | The 10 Meter Walk Test (10MWT) evaluates gait speed similarly in separate trials with the participant instructed to walk at comfortable and fast pace, and velocity timed over the middle six meters. This outcome is the velocity (meters/second) with instructions to walk at a fast pace, performed off medication. Higher velocities indicate better motor function. | Baseline, 6 months, 12 months |
| Timed Up and Go (TUG) Test Duration | iPad-facilitated Timed Up and Go Test duration, measured off medication. The Timed "Up & Go" (TUG) Test requires an individual to (1) stand from a chair, (2) ambulate 3 m, (3) turn 180 degrees, (4) ambulate back to the chair, and (5) turn and sit. To perform an instrumented TUG, an Apple iPad is attached to the individual's waist (sacral level) via an adjustable belt. This outcome is the total time to complete this test, in seconds, measured off medication. Lower times indicate better motor function. | Baseline, 6 months, 12 months |
| Timed Up and Go (TUG) Test Turning Velocity | iPad-facilitated Timed Up and Go Test mean turning velocity, measured off medication. The Timed "Up & Go" (TUG) Test requires an individual to (1) stand from a chair, (2) ambulate 3 m, (3) turn 180 degrees, (4) ambulate back to the chair, and (5) turn and sit. To perform an instrumented TUG, an Apple iPad is attached to the individual's waist (sacral level) via an adjustable belt. This outcome is the mean velocity during performance of step (3), turn 180 degrees, in degrees/second, measured off medication. Higher turn velocities indicate better motor function. | Baseline, 6 months, 12 months |
| Manual Dexterity Test Completion Time | Manual Dexterity Test time to completion in seconds, measured off medication. This test is an electronic (iPad-based), modified version of the 9-hole peg test, where an individual is required to grasp, transfer, and release pegs into a 3×3 grid. Participants are asked to grasp and place pegs into holes, and then to return them to their starting locations, as rapidly as possible. Completion times for two repetitions conducted with each hand were averaged. Shorter completion times indicate better motor function. | Baseline, 6 months, 12 months |
| Processing Speed Test Match Score | The Processing Speed Test is a self-administered electronic (iPad) facilitated symbol-number matching task that is similar to the Symbol Digital Modalities Test. Participants are shown a table with numerical labels for 9 disparate symbols, and a second table with a row of such symbols and a blank row beneath it, and asked to complete the second table with the numbers from the first table corresponding to each symbol in the second. When the table is completed, additional tables are shown. The response recorded is the number of correct matches of symbols with numbers in 120 seconds, measured off medication. Higher values indicate faster neural processing. | Baseline, 6 months, 12 months |
| Trail Making Test (TMT) B to A Duration Ratio | Participants completed iPad versions of Trail Making Tests A and B (TMT A and B, respectively), with durations in seconds recorded for each. TMT A, considered predominantly a motor task, requires the participant to use a stylus to connect dots in ascending numeric order (1-2-3-4 . . . ). The TMT B, requires the participant to connect dots in an ascending and alternating alpha and numeric order (1-A-2-B . . . .). The total times to complete each of the TMT A and B tasks are automatically recorded by the iPad. This outcome is the (unitless) ratio of the duration to complete Trail Making Test B to the duration to complete Trail Making Test A, reflecting the cognitive burden of visual attention and set-switching, measured off medication. Higher values reflect greater relative burden of the additional cognitive component. | Baseline, 6 months, 12 months |
| Visual Memory Test Symbol Recall Score | Electronics-based test of episodic memory performed on an iPad, reported as number of correctly recalled symbols arrayed on a grid, with values ranging from 0 to 70 and higher numbers reflective of better memory, measured off medication. | Baseline, 6 months, 12 months |
| Salt Lake City |
| Utah |
| 84108 |
| United States |
| 40194736 | Background | Rosenfeldt AB, Penko AL, Jansen AE, Lopez-Lennon C, Zimmerman E, Imrey PB, Singh TK, Dibble LE, Alberts JL. Refining Maximal Heart Rate Estimation to Enhance Exercise Recommendations for Persons With Parkinson Disease. Arch Phys Med Rehabil. 2025 Nov;106(11):1680-1684. doi: 10.1016/j.apmr.2025.03.046. Epub 2025 Apr 5. |
| 34363478 | Background | Alberts JL, Rosenfeldt AB, Lopez-Lennon C, Suttman E, Jansen AE, Imrey PB, Dibble LE. Effectiveness of a Long-Term, Home-Based Aerobic Exercise Intervention on Slowing the Progression of Parkinson Disease: Design of the Cyclical Lower Extremity Exercise for Parkinson Disease II (CYCLE-II) Study. Phys Ther. 2021 Nov 1;101(11):pzab191. doi: 10.1093/ptj/pzab191. |
| 28080262 | Background | Rao SM, Losinski G, Mourany L, Schindler D, Mamone B, Reece C, Kemeny D, Narayanan S, Miller DM, Bethoux F, Bermel RA, Rudick R, Alberts J. Processing speed test: Validation of a self-administered, iPad(R)-based tool for screening cognitive dysfunction in a clinic setting. Mult Scler. 2017 Dec;23(14):1929-1937. doi: 10.1177/1352458516688955. Epub 2017 Jan 12. |
| 32925109 | Background | Alberts JL, Rosenfeldt AB. The Universal Prescription for Parkinson's Disease: Exercise. J Parkinsons Dis. 2020;10(s1):S21-S27. doi: 10.3233/JPD-202100. |
| 39604309 | Result | Jansen AE, Rosenfeldt AB, Lopez-Lennon C, Fernandez H, Zimmerman E, Imrey PB, Dibble LE, Alberts JL. Characterizing Hand Function in Parkinson's Disease Patients with a Self-Administered Electronic Manual Dexterity Test. Mov Disord Clin Pract. 2025 Mar;12(3):333-339. doi: 10.1002/mdc3.14286. Epub 2024 Nov 27. |
| 39589012 | Result | Rosenfeldt AB, Jansen AE, Lopez-Lennon C, Zimmerman E, Imrey PB, Dibble LE, Alberts JL. Physical Activity Declines over a 12-Month Period in Parkinson's Disease: Considerations for Longitudinal Activity Monitoring. Med Sci Sports Exerc. 2025 Apr 1;57(4):738-745. doi: 10.1249/MSS.0000000000003615. Epub 2024 Nov 26. |
| 39956037 | Result | Anis S, Zimmerman E, Jansen AE, Kaya RD, Fernandez HH, Lopez-Lennon C, Dibble LE, Rosenfeldt AB, Alberts JL. Cognitive measures predict falls in Parkinson's disease: Insights from the CYCLE-II cohort. Parkinsonism Relat Disord. 2025 Apr;133:107328. doi: 10.1016/j.parkreldis.2025.107328. Epub 2025 Feb 11. |
| 38206881 | Result | Rosenfeldt AB, Lopez-Lennon C, Suttman E, Jansen AE, Owen K, Dibble LE, Alberts JL. Use of a Home-Based, Commercial Exercise Platform to Remotely Monitor Aerobic Exercise Adherence and Intensity in People With Parkinson Disease. Phys Ther. 2024 Feb 1;104(2):pzad174. doi: 10.1093/ptj/pzad174. |
| 42224911 | Derived | Jansen AE, Cantlay P, Felix C, Rosenfeldt AB, Lopez-Lennon C, Fernandez H, Zimmerman E, Imrey PB, Dibble LE, Alberts JL. A machine learning approach to quantifying fall conversion risk in fall-naive Parkinson's patients. Parkinsonism Relat Disord. 2026 May 25;148:108368. doi: 10.1016/j.parkreldis.2026.108368. Online ahead of print. |
| 38588457 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3. |
| 36602886 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2. |
| BG001 | Usual and Customary Care Group | Mild to moderate Parkinson's disease patients receiving no active exercise intervention through the research. These participants continued to receive usual and customary care (UCC) for their Parkinson's disease during the 12 month follow-up period. Participants receive and are asked to wear activity monitors throughout the day to monitor daily activity levels, and not to commence a cycling exercise program for the duration of the 12 month follow-up period. Participants also receive biweekly telephone calls to review electronic activity monitoring data, monitor falls and adverse events, and to provide them similar contact time as for the active exercise group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination) | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. | All observed data are summarized; 5 participants, 3 in the aerobic exercise (AE) and 2 in the usual care (UC) arm, withdrew prior to initiating randomized treatment and follow-up, of whom 4 had not yet completed the baseline MDS-UPDRS III. One participant was withdrawn by the study PI due to periodic atrial fibrillation, 2 withdrew due to COVID-19 pandemic-related logistical issues and safety concerns, and 2 withdrew due to dissatisfaction with their randomized usual care assignments. | Mean | Standard Deviation | units on a scale |
|
| Clinical Site | Count of Participants | Participants |
|
Continue regular activity. No aerobic exercise intervention. |
|
|
|
| Secondary | 10 Meter Walk Test (10MWT) Comfortable Pace Velocity | The 10 Meter Walk Test (10MWT) evaluates gait speed similarly in separate trials with the participant instructed to walk at comfortable and fast pace, and velocity timed over the middle six meters. This outcome is the velocity (meters/second) with instructions to walk at a comfortable pace, performed off medication. Higher velocities indicate better motor function. | Medians and interquartile ranges are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Median | Inter-Quartile Range | meters/second | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | 10 Meter Walk Test (10MWT) Fast Pace Velocity | The 10 Meter Walk Test (10MWT) evaluates gait speed similarly in separate trials with the participant instructed to walk at comfortable and fast pace, and velocity timed over the middle six meters. This outcome is the velocity (meters/second) with instructions to walk at a fast pace, performed off medication. Higher velocities indicate better motor function. | Means and standard deviations are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Mean | Standard Deviation | meters/second | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | Timed Up and Go (TUG) Test Duration | iPad-facilitated Timed Up and Go Test duration, measured off medication. The Timed "Up & Go" (TUG) Test requires an individual to (1) stand from a chair, (2) ambulate 3 m, (3) turn 180 degrees, (4) ambulate back to the chair, and (5) turn and sit. To perform an instrumented TUG, an Apple iPad is attached to the individual's waist (sacral level) via an adjustable belt. This outcome is the total time to complete this test, in seconds, measured off medication. Lower times indicate better motor function. | Medians and interquartile ranges are reported for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic modeling results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Median | Inter-Quartile Range | seconds | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | Timed Up and Go (TUG) Test Turning Velocity | iPad-facilitated Timed Up and Go Test mean turning velocity, measured off medication. The Timed "Up & Go" (TUG) Test requires an individual to (1) stand from a chair, (2) ambulate 3 m, (3) turn 180 degrees, (4) ambulate back to the chair, and (5) turn and sit. To perform an instrumented TUG, an Apple iPad is attached to the individual's waist (sacral level) via an adjustable belt. This outcome is the mean velocity during performance of step (3), turn 180 degrees, in degrees/second, measured off medication. Higher turn velocities indicate better motor function. | Means and standard deviations are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Mean | Standard Deviation | degrees/second | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | Manual Dexterity Test Completion Time | Manual Dexterity Test time to completion in seconds, measured off medication. This test is an electronic (iPad-based), modified version of the 9-hole peg test, where an individual is required to grasp, transfer, and release pegs into a 3×3 grid. Participants are asked to grasp and place pegs into holes, and then to return them to their starting locations, as rapidly as possible. Completion times for two repetitions conducted with each hand were averaged. Shorter completion times indicate better motor function. | Medians and interquartile ranges are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Median | Inter-Quartile Range | Time (seconds) to completion | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | Processing Speed Test Match Score | The Processing Speed Test is a self-administered electronic (iPad) facilitated symbol-number matching task that is similar to the Symbol Digital Modalities Test. Participants are shown a table with numerical labels for 9 disparate symbols, and a second table with a row of such symbols and a blank row beneath it, and asked to complete the second table with the numbers from the first table corresponding to each symbol in the second. When the table is completed, additional tables are shown. The response recorded is the number of correct matches of symbols with numbers in 120 seconds, measured off medication. Higher values indicate faster neural processing. | Medians and interquartile ranges are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Median | Inter-Quartile Range | Correct symbol/number matches | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | Trail Making Test (TMT) B to A Duration Ratio | Participants completed iPad versions of Trail Making Tests A and B (TMT A and B, respectively), with durations in seconds recorded for each. TMT A, considered predominantly a motor task, requires the participant to use a stylus to connect dots in ascending numeric order (1-2-3-4 . . . ). The TMT B, requires the participant to connect dots in an ascending and alternating alpha and numeric order (1-A-2-B . . . .). The total times to complete each of the TMT A and B tasks are automatically recorded by the iPad. This outcome is the (unitless) ratio of the duration to complete Trail Making Test B to the duration to complete Trail Making Test A, reflecting the cognitive burden of visual attention and set-switching, measured off medication. Higher values reflect greater relative burden of the additional cognitive component. | Medians and interquartile ranges are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Median | Inter-Quartile Range | unitless ratio | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | Visual Memory Test Symbol Recall Score | Electronics-based test of episodic memory performed on an iPad, reported as number of correctly recalled symbols arrayed on a grid, with values ranging from 0 to 70 and higher numbers reflective of better memory, measured off medication. | Medians and quartiles are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic modeling results reported below are based on the full intention-to-treat population, with missing data multiply-imputed. | Posted | Median | Inter-Quartile Range | Number correct | Baseline, 6 months, 12 months |
|
|
|
|
| 129 |
| 10 |
| 129 |
| 27 |
| 129 |
| EG001 | Usual and Customary Care Group | Continue regular activity. No aerobic exercise intervention. | 0 | 127 | 15 | 127 | 0 | 127 |
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Psychiatric disorder | Psychiatric disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Surgical and medical procedure | Surgical and medical procedures | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous System Disorder | Nervous system disorders | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 6 months |
|
|
| 12 months |
|
|
The reported effect is the difference in annual slope of meters^2/second, in 100ths of meters^2/second/year. The confidence interval is not multiple comparison adjusted. Parkinson's progression limits mobility; higher slope reflects less progression. |
| Superiority |
Equality of annual slopes in squared 10 Meter Walk Test Comfortable Pace Velocity for the AE and UCC groups. |
| 6 months |
|
|
| 12 months |
|
|
| Superiority |
Equality of annual slopes in 10 Meter Walk Test Fast Pace Velocity for the AE and UCC groups. |
| 6 months |
|
|
| 12 months |
|
|
| 7.89 |
Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a TUG completion/second/year. |
| Superiority |
Equality of annual slopes of inverse Timed Up and Go Test duration, i.e., of TUG completions/second, the speed of completing the test. |
| 6 months |
|
|
| 12 months |
|
|
| Superiority |
Test of equality of average turning velocities. |
| 6 months |
|
|
| 12 months |
|
|
Manual dexterity expressed as peg transfers/second is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a peg transfer/second/year. |
| Superiority |
Test of equality of slopes of test performance speed (peg transfers/second/year) for AE and UCC groups. |
| 6 month |
|
|
| 12 month |
|
|
Processing speed is expected to decline with Parkinson's, hence duration of the test to increase. The reported effect is the difference in annual slopes (matches^2/year) between the AE and UCC treatment arms. |
| Superiority |
Test of equality of slopes of squared match scores (matches^2/year) between AE and UCC groups. |
| 6 months |
|
|
| 12 months |
|
|
Visual attention and set switching speed decline with Parkinson's, hence duration of Trail Making Test B increases. The reported effect is the difference in annual slopes of (log TMT B/TMT A), i.e., change/year, between AE and UCC treatment arms. |
| Superiority |
Test of equality of annual slopes of log(TMT B to TMT A duration ratio) for AE and UCC groups. |
| 6 month |
|
|
| 12 month |
|
|
Visual memory declines with Parkinson's, hence the score declines. The reported effect is the difference in annual slopes, i.e., changes in mean score^2/year, for AE and UCC treatment arms, shown in hundreds. Higher slope indicates slower decline.
| Superiority |
Test of equality of annual slopes of squared test score. |