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Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans.

ABSTRACT: A burgeoning literature suggests that exercise has a therapeutic benefit in persons with Parkinson disease (PD) and in animal models of PD, especially when animals exercise at high intensity. If exercise is to be prescribed as "first-line" or "add-on" therapy in patients with PD, we must demonstrate its efficacy and dose-response effects through testing phases similar to those used in the testing of pharmacologic agents. The SPARX Trial is a multicenter, randomized, controlled, single-blinded, Phase II study that we designed to test the feasibility of using high-intensity exercise to modify symptoms of PD and to simultaneously test the nonfutility of achieving a prespecified change in patients' motor scores on the Unified Parkinson Disease Rating Scale (UPDRS). The trial began in May 2102 and is in the process of screening, enrolling, and randomly assigning 126 patients with early-stage PD to 1 of 3 groups: usual care (wait-listed controls), moderate-intensity exercise (4 days/week at 60%-65% maximal heart rate [HRmax]), or high-intensity exercise (4 days/week at 80%-85% HRmax). At 6-month follow-up, the trial is randomly reassigning usual care participants to a moderate-intensity or high-intensity exercise group for the remaining 6 months. The goals of the Phase II trial are to determine if participants can exercise at moderate and high intensities; to determine if either exercise yields benefits consistent with meaningful clinical change (nonfutility); and to document safety and attrition. The advantage of using a non-futility approach allows us to efficiently determine if moderate- or high-intensity exercise warrants further large-scale investigation in PD.

SUBMITTER: Moore CG

PROVIDER: S-EPMC3769494 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans.

Moore Charity G CG Schenkman Margaret M Kohrt Wendy M WM Delitto Anthony A Hall Deborah A DA Corcos Daniel D

Contemporary clinical trials 20130614 1

A burgeoning literature suggests that exercise has a therapeutic benefit in persons with Parkinson disease (PD) and in animal models of PD, especially when animals exercise at high intensity. If exercise is to be prescribed as "first-line" or "add-on" therapy in patients with PD, we must demonstrate its efficacy and dose-response effects through testing phases similar to those used in the testing of pharmacologic agents. The SPARX Trial is a multicenter, randomized, controlled, single-blinded, P ...[more]

PMID: 23770108

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Project description:Importance:Parkinson disease is a progressive neurologic disorder. Limited evidence suggests endurance exercise modifies disease severity, particularly high-intensity exercise. Objectives:To examine the feasibility and safety of high-intensity treadmill exercise in patients with de novo Parkinson disease who are not taking medication and whether the effect on motor symptoms warrants a phase 3 trial. Design, Setting, and Participants:The Study in Parkinson Disease of Exercise (SPARX) was a phase 2, multicenter randomized clinical trial with 3 groups and masked assessors. Individuals from outpatient and community-based clinics were enrolled from May 1, 2012, through November 30, 2015, with the primary end point at 6 months. Individuals with idiopathic Parkinson disease (Hoehn and Yahr stages 1 or 2) aged 40 to 80 years within 5 years of diagnosis who were not exercising at moderate intensity greater than 3 times per week and not expected to need dopaminergic medication within 6 months participated in this study. A total of 384 volunteers were screened by telephone; 128 were randomly assigned to 1 of 3 groups (high-intensity exercise, moderate-intensity exercise, or control). Interventions:High-intensity treadmill exercise (4 days per week, 80%-85% maximum heart rate [n = 43]), moderate-intensity treadmill exercise (4 days per week, 60%-65% maximum heart rate [n = 45]), or wait-list control (n = 40) for 6 months. Main Outcomes and Measures:Feasibility measures were adherence to prescribed heart rate and exercise frequency of 3 days per week and safety. The clinical outcome was 6-month change in Unified Parkinson's Disease Rating Scale motor score. Results:A total of 128 patients were included in the study (mean [SD] age, 64 [9] years; age range, 40-80 years; 73 [57.0%] male; and 108 [84.4%] non-Hispanic white). Exercise rates were 2.8 (95% CI, 2.4-3.2) days per week at 80.2% (95% CI, 78.8%-81.7%) maximum heart rate in the high-intensity group and 3.2 (95% CI, 2.8-3.6; P = .13) days per week at 65.9% (95% CI, 64.2%-67.7%) maximum heart rate in the moderate-intensity group (P < .001). The mean change in Unified Parkinson's Disease Rating Scale motor score in the high-intensity group was 0.3 (95% CI, -1.7 to 2.3) compared with 3.2 (95% CI, 1.4 to 5.1) in the usual care group (P = .03). The high-intensity group, but not the moderate-intensity group, reached the predefined nonfutility threshold compared with the control group. Anticipated adverse musculoskeletal events were not severe. Conclusions and Relevance:High-intensity treadmill exercise may be feasible and prescribed safely for patients with Parkinson disease. An efficacy trial is warranted to determine whether high-intensity treadmill exercise produces meaningful clinical benefits in de novo Parkinson disease. Trial Registration:clinicaltrials.gov Identifier: NCT01506479.

Project description:IntroductionExercise at high intensity may cause lower affective responses toward exercise compared with moderate intensity exercise. We aimed to elucidate affective valence and enjoyment in high- and moderate-high interval exercise.MethodsTwenty recreationally active participants (9 females, 11 males, age range: 20-51 years) underwent three different treadmill running exercise sessions per week over a 3-week period, in randomized order; (1) CE70: 45 min continuous exercise at 70% of heart rate maximum (HRmax), (2) INT80: 4 × 4 min intervals at 80% of HRmax, (3) INT90: 4 × 4 min intervals at 90% of HRmax. Pre-tests included graded submaximal steady state intensities and a test to exhaustion for determining peak oxygen uptake and HRmax. Affective valence (pleasure/displeasure) was measured before, during and after the sessions using the Feeling Scale (FS). Enjoyment was assessed before and after the sessions applying the Physical Activity Enjoyment Scale (PACES) and during the sessions using the Exercise Enjoyment Scale (EES).ResultsThe participants felt lower pleasure (between-sessions effect: p = 0.02, p η2: 0.13) during INT90 sessions (FS: 1.08, 95% CI: 0.35-1.92) compared with INT80 (FS: 2.35, 95% CI: 1.62-3.08, p = 0.052) and CE70 sessions (FS: 2.45, 95% CI: 1.72-3.18, p = 0.03), with no differences between INT80 and CE70 sessions (p = 1.00). There were higher enjoyment after INT80 sessions (PACES: 101.5, 95% CI: 95.7-107.3) versus CE70 sessions (PACES: 91.3 95% CI: 85.5-97.1, p = 0.046), and no differences between INT90 (PACES: 98.2, 95% CI: 92.4-103.4) and CE70 (p = 0.29) or INT80 (p = 1.00). For enjoyment during exercise, CE70 were perceived more enjoyable, and INT80 and INT90 less enjoyable in week 2 (EES: week x session: p = 0.01, p η2: 0.11; CE70: 4.3, 95% CI: 3.6-4.9, INT80: 4.6, 95% CI: 3.9-5.2, INT90: 4.0, 95% CI: 3.4-4.7) and 3 (EES: CE70: 4.2, 95% CI: 3.7-4.8, INT80: 4.8, 95% CI: 4.2-5.3, INT90: 4.3, 95% CI: 3.8-4.9) than in week 1 (EES: CE70: 3.5, 95% CI: 3.0-4.0, INT80: 5.0, 95% CI: 4.5-5.5, INT90: 4.5, 95% CI: 4.0-5.0).ConclusionThe negative affective consequences associated with high intensity interval exercise can be alleviated by keeping the intensity at or around 80% of HRmax while preserving the beneficial enjoyment responses associated with interval exercise.

Project description:Concurrent aerobic plus resistance exercise (RAE) and high-intensity interval exercise (HIIE) are both effective at inducing post-exercise hypotension (PEH) in patients with hypertension. However, central hemodynamic changes associated with PEH in hypertensive subjects with underlying ischemic heart disease (IHD) have been poorly investigated. The study aim was to compare the acute effects produced by these two exercise modalities on left ventricular diastolic function and left atrial function. Twenty untrained male patients with a history of hypertension and IHD under stable pharmacological therapy were enrolled. Each patient underwent three exercise sessions: RAE, HIIE and a control session without exercise, each lasting 45 min. An echocardiography examination was performed before and between 30 min and 40 min from the end of the exercise sessions. Following the exercise sessions, BP values decreased in a similar way in RAE and HIIE and were unchanged after the control session. Compared to pre-session, the ratio between early filling velocity (E) and mitral annulus early diastolic velocity (E'). E/E' increased after HIIE and remained unchanged after both RAE and control sessions (between-sessions p 0.002). Peak atrial longitudinal strain (PALS) increased slightly after RAE (+1.4 ± 1.1%), decreased after HIIE (-4.6 ± 2.4%) and was unchanged after the control session (between-sessions p 0.03). Peak atrial contraction strain (PACS) was mildly increased after RAE, was reduced after HIIE and was unchanged after the control session. Atrial volume was unchanged after both exercise sessions. Left ventricular and left atrial stiffness increased significantly after HIIE, but remained unchanged after the RAE and control sessions. Stroke volume and cardiac output increased after RAE, decreased after HIIE, and were unchanged after the control session. In conclusion, single session of RAE and HIIE brought about similar PEH in hypertensive subjects with IHD, while they evoked different central hemodynamic adjustments. Given its neutral effects on diastolic and atrial functions, RAE seems more suitable for reducing blood pressure in hypertensive patients with IHD.

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Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans.

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Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans.

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