Study in Parkinson's disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial.

BACKGROUND: To date, no medication has slowed the progression of Parkinson's disease (PD). Preclinical, epidemiological, and experimental data on humans all support many benefits of endurance exercise among persons with PD. The key question is whether there is a definitive additional benefit of exercising at high intensity, in terms of slowing disease progression, beyond the well-documented benefit of endurance training on a treadmill for fitness, gait, and functional mobility. This study will determine the efficacy of high-intensity endurance exercise as first-line therapy for persons diagnosed with PD within 3 years, and untreated with symptomatic therapy at baseline. METHODS: This is a multicenter, randomized, evaluator-blinded study of endurance exercise training. The exercise intervention will be delivered by treadmill at 2 doses over 18 months: moderate intensity (4 days/week for 30 min per session at 60-65% maximum heart rate) and high intensity (4 days/week for 30 min per session at 80-85% maximum heart rate). We will randomize 370 participants and follow them at multiple time points for 24 months. The primary outcome is the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor score (Part III) with the primary analysis assessing the change in MDS-UPDRS motor score (Part III) over 12 months, or until initiation of symptomatic antiparkinsonian treatment if before 12 months. Secondary outcomes are striatal dopamine transporter binding, 6-min walk distance, number of daily steps, cognitive function, physical fitness, quality of life, time to initiate dopaminergic medication, circulating levels of C-reactive protein (CRP), and brain-derived neurotrophic factor (BDNF). Tertiary outcomes are walking stride length and turning velocity. DISCUSSION: SPARX3 is a Phase 3 clinical trial designed to determine the efficacy of high-intensity, endurance treadmill exercise to slow the progression of PD as measured by the MDS-UPDRS motor score. Establishing whether high-intensity endurance treadmill exercise can slow the progression of PD would mark a significant breakthrough in treating PD. It would have a meaningful impact on the quality of life of people with PD, their caregivers and public health. TRIAL REGISTRATION: ClinicalTrials.gov NCT04284436 . Registered on February 25, 2020.

Self-Reported Exercise Trends in Parkinson's Disease Patients.

OBJECTIVE: To examine trends in type, frequency, and effectiveness of different modes of exercise in patients with Parkinson's Disease (PD). BACKGROUND: Exercise has been shown to improve symptoms in PD patients. Recent studies suggest that dance may be a particularly helpful exercise option. However, it remains unclear how the benefits of various forms of exercise compare to dance and to each other. Information on these trends can help inform future exercise programs for PD patients. METHOD: 55 PD patients completed a survey on their exercise frequency, the impact of exercise on their symptoms, and whether they exercise alone or in groups. 9 PD patients who attend dance therapy classes completed an extended survey with additional questions comparing the benefit of dance therapy to traditional forms of exercise. RESULTS: Of the 64 patients surveyed, 67% of patients exercised at least twice a week for at least 30 minutes at a time, and 28% of patients exercised alone only. Walking was most commonly reported (77%), followed by stretching (52%), and weights (28%). 97% of patients who exercised noted mitigation of their PD symptoms. Additionally, a significantly greater percentage of patients who exercised in groups reported symptomatic improvements compared to patients who only exercised alone (p = 0.03). CONCLUSION: More patients who participated in group exercise reported symptomatic improvement compared to those who exercised strictly alone. This suggests that the psychosocial and cognitive component of group therapy, such as dance, may confer additional benefits to PD patients.

Oximetry as an Accurate Tool for Identifying Moderate to Severe Sleep Apnea in Patients With Acute Stroke.

STUDY OBJECTIVES: Sleep-disordered breathing (SDB) is highly prevalent in patients with acute stroke. SDB is often underdiagnosed and associated with neurological deterioration and stroke recurrence. Polysomnography or home sleep apnea testing (HSAT) is typically used as the diagnostic modality; however, it may not be feasible to use regularly in patients with acute stroke. We investigated the predictive performance of pulse oximetry, a simpler alternative, to identify SDB. METHODS: The records of 254 patients, who were admitted to Boston Medical Center for acute stroke and underwent HSAT, were retrospectively reviewed. Oxygen desaturation index (ODI) from pulse oximetry channel were compared to respiratory event index (REI) obtained from HSAT devices. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ODI were calculated, and different ODI cutoff values to predict SDB were proposed. RESULTS: ODI had a strong correlation (r = .902) and agreement with REI. ODI was accurate in predicting SDB at different REI thresholds (REI ≥ 5, REI ≥ 15, and REI ≥ 30 events/h) with the area under the curve (AUC) of .965, .974, and .951, respectively. An ODI ≥ 5 events/h rules in the presence of SDB (specificity 91.7%, PPV 96.3%). An ODI ≥ 15 events/h rules in moderate to severe SDB (specificity 96.4%, PPV 95%) and an ODI < 5 events/h rules out moderate to severe SDB (sensitivity 100%, NPV 100%). CONCLUSIONS: Nocturnal pulse oximetry has a high diagnostic accuracy in predicting moderate to severe SDB in patients with acute stroke. Oximetry can be a simple modality to rapidly recognize patients with more severe SDB and facilitate the referral to the confirmation sleep study.