Trial results for the Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease were posted on ClinicalTrials.gov on 2025-06-18, indicating a significant improvement in motor examination scores. The study enrolled 256 participants, with key analyses showing a -3.62 difference in slopes for motor scores (p=0.0001) in favor of the exercise group.
Background
Parkinson's Disease (PD) is a progressive neurodegenerative disorder. A significant unmet need in PD treatment is the identification of effective disease-modifying interventions. Increasing evidence suggests that high-intensity aerobic exercise may alter PD progression. This trial aimed to examine the capabilities of a long-term, high-intensity aerobic exercise intervention.
Trial design
This completed, multi-site pragmatic randomized controlled trial (Phase NA) enrolled 256 individuals with Parkinson Disease. Participants were randomized into a home-based aerobic exercise program or a usual and customary care (UCC) group. The primary aim was to examine the disease-altering capabilities of the long-term, high-intensity aerobic exercise intervention.
Key results
The trial reported key measurements and analyses related to motor function and gait velocity. For the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score, mean scores for the Aerobic Exercise Group ranged from 35.9 (Standard Deviation 14.1) to 38.5 (Standard Deviation 15.6). For the Usual and Customary Care Group, mean scores ranged from 36.9 (Standard Deviation 14.2) to 40.5 (Standard Deviation 16.4).
For the 10 Meter Walk Test (10MWT) Comfortable Pace Velocity, median velocities for the Aerobic Exercise Group ranged from 1.22 to 1.24 meters/second. For the Usual and Customary Care Group, median velocities ranged from 1.24 to 1.26 meters/second.
Key analyses using a Mixed Models Analysis for baseline, 6-month, and 12-month data revealed significant findings:
- For the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score, there was a significant "Difference in slopes" of -3.62 (95.0% Confidence Interval: -5.4 to -1.85) between the treatment arms, with a p-value of 0.0001. This analysis used a linear mixed model with fixed effects of clinical site, treatment, and linear time nested in treatment arm.
- For the 10 Meter Walk Test (10MWT) Comfortable Pace Velocity (modeled as squared velocity), a "Difference in squared velocity slopes" of 12.07 (95.0% Confidence Interval: 3.1 to 21.32) was observed, with a p-value of 0.043. This analysis also used a linear mixed model, noting that the study's sample size was based on the primary outcome, and power was not calculated for this outcome.
- Other analyses, including those for other outcomes, did not show statistical significance, with p-values of 0.48, 0.16, 0.69, and 0.72 for various "Difference in slopes" parameters.
What this means
The results from this pragmatic trial suggest that a home-based aerobic exercise program can significantly improve motor function in individuals with Parkinson's Disease compared to usual care. The statistically significant reduction in the slope of the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III motor examination scores for the exercise group indicates a beneficial effect on disease progression or symptom management over time. The observed improvement in 10-meter walk test velocity further supports the potential for exercise to positively impact gait and mobility. These findings underscore the importance of high-intensity aerobic exercise as a potential strategy in PD management.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04000360, titled "Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease", were posted on 2025-06-18 on clinicaltrials.gov.