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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
256
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.
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).
Cleveland Clinic
Cleveland, Ohio, United States
University of Utah
Salt Lake City, Utah, United States
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.
Time frame: Baseline, 6 months, 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months, 12 months
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