Objective: Our first objective was to determine whether people with de novo Parkinson’s disease (PD) are able to exercise at either 60-65% maximal heart rate (HRmax) or 80-85% HRmax and adhere to the exercise protocol. Our second objective was to determine whether moderate- (60-65%) and/or high-intensity (80-85%) endurance exercise [or both] warrant further investigation as a therapeutic intervention for motor symptoms in the treatment of de novo PD. Our third objective was to determine the incidence of adverse events and 6-month attrition associated with each protocol. 

Background: There is limited evidence that endurance exercise modifies disease severity in PD, and whether there is an effect of exercise intensity. This study determined the feasibility and benefits of moderate- vs high-intensity endurance exercise on changes in disease severity. 

Methods: This was a Phase II, multicenter, randomized, controlled futility trial in early stage, de novo PD. Participants were randomized to high-intensity treadmill exercise (4 days per week at 80%-85% HRmax), moderate-intensity treadmill exercise (4 days per week at 60%-65% HRmax), or wait-list control for 6 months. Primary feasibility measures were percentage of HRmax and adherence to exercise frequency. The primary futility measure was the 6-month change in the motor score of the Unified Parkinson’s Disease Rating Scale (UPDRS).

Results: The high-intensity (n=43) and moderate-intensity groups (n=45) exercised at 80.2% (78.8%, 81.7%) and 65.9% (64.2%, 67.7%) HRmax for an average of 2.8 (2.4, 3.2) and 3.2 (2.8, 3.6) days per week. The UPDRS motor score change after 6 months was 0.3 ± 6.3 in the high-intensity, 2.0 ± 5.3 in the moderate-intensity, and 3.2 ± 5.6 in the control. High-intensity, but not moderate-intensity, exercise reached the non-futility threshold (null-adjusted difference, CI): -0.6 (<1.2) and -2.3 (<-0.7), respectively.  Adverse musculoskeletal events were more frequent for the high intensity group. Five people in the high intensity and 3 people in the moderate-intensity group did not complete 6 months of exercise.

Conclusions: We demonstrate for the first time the feasibility and safety of high-intensity endurance exercise in de novo PD. Our findings further support that a larger trial is warranted to determine whether high-intensity endurance exercise produces meaningful clinical benefits in de novo PD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/study-in-parkinsons-disease-of-exercise-sparx-a-randomized-controlled-futility-trial/