Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2012-05-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control Group
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
No Intervention
No-exercise control (i.e., usual care);
Vigorous Exercise
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Vigorous Exercise
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Moderate Exercise
Endurance exercise at 60-65% HR max, 4x/wk for 6 months.
Moderate Exercise
Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Interventions
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Moderate Exercise
Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Vigorous Exercise
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
No Intervention
No-exercise control (i.e., usual care);
Eligibility Criteria
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Inclusion Criteria
* In a Hoehn and Yahr stage less than stage III
* Disease duration is less than 5 years
* Not likely to require dopaminergic therapy within 6 months
Exclusion Criteria
* Duration of previous use of medications for PD that exceeds 90 days
* Expected to require dopaminergic therapy in the next 6 months
* Poorly controlled or unstable cardiovascular disease
* Uncontrolled hypertension
* Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function
* Mild cognitive impairment (Montreal Cognitive Assessment score\<26/30)
* Depression that precludes ability to exercise (Beck depression score\>13)
* Disorders that interfere with ability to perform endurance exercises
* Regular participation in vigorous endurance exercise
* Evidence of serious arrhythmias or ischemic heart disease
* Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study
40 Years
80 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
University of Pittsburgh
OTHER
Rush University Medical Center
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Northwestern University
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Margaret Schenkman, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Daniel Corcos, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Colorado Denver
Aurora, Colorado, United States
University of Illinois, Chicago
Chicago, Illinois, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
Hall DA, Moore C, Comella C; SPARX Study Group. Recruitment of patients with de novo Parkinson disease: successful strategies in a randomized exercise clinical trial. Trials. 2018 Nov 14;19(1):630. doi: 10.1186/s13063-018-2958-z.
Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
Moore CG, Schenkman M, Kohrt WM, Delitto A, Hall DA, Corcos D. Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Contemp Clin Trials. 2013 Sep;36(1):90-8. doi: 10.1016/j.cct.2013.06.002. Epub 2013 Jun 14.
Other Identifiers
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11-1237
Identifier Type: -
Identifier Source: org_study_id