N/A
Completed N=256
Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Source: ClinicalTrials.gov NCT04000360 ↗Enrolled (actual)
256
Serious AEs
9.8%
Results posted
Jun 2025
Primary outcomePrimary: Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score — 38.5; 36.9; 35.9; 38.8 Score on a scale — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score |
38.5; 36.9; 35.9; 38.8; 37.1; 40.5 | <0.0001 sig |
| SECONDARY 10 Meter Walk Test (10MWT) Comfortable Pace Velocity |
1.22; 1.26; 1.23; 1.25; 1.24; 1.24 | 0.043 sig |
| SECONDARY 10 Meter Walk Test (10MWT) Fast Pace Velocity |
1.66; 1.67; 1.67; 1.64; 1.67; 1.64 | 0.48 |
| SECONDARY Timed Up and Go (TUG) Test Duration |
9.9; 10.0; 10.4; 10.3; 9.9; 10.3 | 0.16 |
| SECONDARY Timed Up and Go (TUG) Test Turning Velocity |
77.3; 78.5; 76.3; 74.5; 77.1; 76.8 | 0.69 |
| SECONDARY Manual Dexterity Test Completion Time |
26.4; 26.1; 26.4; 26.0; 26.1; 26.5 | 0.72 |
| SECONDARY Processing Speed Test Match Score |
45.0; 44.0; 46.0; 45.0; 44.0; 45.0 | 0.48 |
| SECONDARY Trail Making Test (TMT) B to A Duration Ratio |
1.58; 1.55; 1.51; 1.52; 1.44; 1.52 | 1.00 |
| SECONDARY Visual Memory Test Symbol Recall Score |
49; 48; 56; 54; 57.5; 52 | 0.91 |
Eligibility Criteria
Inclusion Criteria
- Adult with a diagnosis of idiopathic PD by a physician or physician extender
- Hoehn and Yahr stage I-III
- Demonstrate the ability to safely mount and dismount the Peloton stationary cycle
- In-home wireless network (WiFi; required for Peloton system exercise data transmission)
Exclusion Criteria
- Participation in pharmaceutical or behavioral disease modifying PD-related clinical trial or study
- Diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent
- Implanted deep brain stimulation electrodes
- If the American College of Sports Medicine (ACSM) screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation.
- Any musculoskeletal issue that would limit one's ability to engage in exercise
- Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)
Data sourced from ClinicalTrials.gov (NCT04000360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.