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A high-intensity exercise boot camp for persons with Parkinson disease: a phase II, pragmatic, randomized clinical trial of feasibility, safety, signal of efficacy, and disease mechanisms
Landers MR, Navalta JW, Murtishaw AS, Kinney JW, Richardson SP
Journal of Neurologic Physical Therapy 2019 Jan;43(1):12-25
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND AND PURPOSE: The feasibility, safety, and efficacy of a high-intensity multimodal exercise program (aerobic, strengthening, and balance training) have not been well vetted in persons with Parkinson disease (PD). Thus, the primary aim was to determine whether a high-intensity multimodal exercise boot camp (HIBC) was both feasible and safe in persons with PD. The secondary aim was to determine whether the program would produce greater benefit than a usual care, low-intensity exercise program (UC). An exploratory aim was to determine whether these programs affected putative disease-modifying mechanisms. METHODS: Twenty-seven participants (19 men and 8 women) were randomized into 8 weeks of either the HIBC or UC supervised by physical therapists. For feasibility, participation, and meeting, Centers for Disease Control and Prevention (CDC) exercise guidelines were assessed. For safety, adverse events were monitored. For efficacy, the following outcome domains were assessed before and after participation: balance, motor activity, endurance and fatigue, strength, mental health, and quality of life. For disease-modifying mechanisms, circulating brain-derived neurotrophic factor (BDNF) and its genotype, superoxide dismutase, and cytokines (tumor necrosis factor-alpha, interleukin-6, and interleukin-10) were monitored. RESULTS: The HIBC was better at attaining CDC guidelines (p = 0.013) and spent more minutes in higher-intensity exercise per week (p < 0.001). There were no differences in adverse events (p = 0.419). The HIBC experienced significant improvements in 7/31 outcomes versus 3/31 in the UC arm. BDNF improved significantly for both groups from pre- to posttests (ps <= 0.041) and an improved anti-inflammatory was observed for both groups. DISCUSSION AND CONCLUSIONS: A high-intensity multimodal exercise boot camp was feasible and safe in persons with PD. Compared with usual care, there were no differences in adverse events. Moreover, the high-intensity multimodal exercise program produced more improvement across more domains than usual care. Our results also suggest a possible link between improvement in outcomes and an improved anti-inflammatory milieu.

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