Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial.
Level 2 - randomized trial
Phase 2 multicenter randomized controlled trial with masked outcome assessors
PubMed 29228079 · doi:10.1001/jamaneurol.2017.3517
What was done
A phase 2, multicenter randomized clinical trial (SPARX) evaluated 128 unmedicated patients with de novo idiopathic Parkinson disease (Hoehn and Yahr stage 1–2, aged 40–80 years, diagnosed within 5 years). Participants were randomly assigned to 6 months of high-intensity treadmill exercise (4 days/week, 80%–85% maximum heart rate [HRmax], n=43), moderate-intensity treadmill exercise (4 days/week, 60%–65% HRmax, n=45), or a wait-list control group (n=40). Primary outcomes included feasibility/safety and the 6-month change in Unified Parkinson's Disease Rating Scale (UPDRS) motor score assessed by masked examiners.
What was found
Participants in the high-intensity group achieved a mean exercise frequency of 2.8 days/week (95% CI, 2.4 to 3.2) at 80.2% HRmax (95% CI, 78.8% to 81.7%). The moderate-intensity group achieved 3.2 days/week (95% CI, 2.8 to 3.6) at 65.9% HRmax (95% CI, 64.2% to 67.7%). The mean 6-month change in UPDRS motor score was 0.3 (95% CI, -1.7 to 2.3) in the high-intensity group versus 3.2 (95% CI, 1.4 to 5.1) in the control group (P = .03). The high-intensity group met the predefined nonfutility threshold compared to control, whereas the moderate-intensity group did not. Musculoskeletal adverse events occurred as anticipated but were not severe.
Why it matters
This study shows that high-intensity endurance exercise is safe and feasible for patients with early-stage, untreated Parkinson disease and may stabilize motor symptoms compared to standard care, supporting progression to a phase 3 trial.
Limits
The study was a phase 2 futility trial with a modest sample size and short duration (6 months), not powered as a definitive efficacy trial. Enrollment was restricted to sedentary, unmedicated patients with early-stage disease (Hoehn and Yahr 1–2), limiting generalizability to patients with advanced disease or those taking dopaminergic medications. The cohort was predominantly non-Hispanic white (84.4%), and the abstract does not report the specific UPDRS motor score change for the moderate-intensity group.
Cited by
- supports A six-month study showed that Parkinson's patients doing high-intensity exercise experienced no disease progression, while non-exercisers had a 15% worsening of motor symptoms.
- supports In a 6-month randomized trial published in JAMA Neurology in December 2017, Parkinson's patients who did not exercise progressed 15% worse on clinical disease progression tests, those doing moderate-intensity exercise progressed 7.5% worse, and those doing high-intensity exercise showed zero progression.