Study in Parkinson's Disease of Exercise (SPARX)

Study Description

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Brief Summary:

The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Behavioral: Moderate Exercise; Behavioral: Vigorous Exercise; Behavioral: No Intervention	Not Applicable

Detailed Description:

The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	128 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease
Actual Study Start Date :	May 2012
Actual Primary Completion Date :	November 2016
Actual Study Completion Date :	November 2016

Arms and Interventions

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Arm	Intervention/treatment
Sham Comparator: Control Group; Wait listed to moderate or vigorous exercise after 6 months of no exercise.	Behavioral: No Intervention; No-exercise control (i.e., usual care);
Experimental: Vigorous Exercise; Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Behavioral: Vigorous Exercise; Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Experimental: Moderate Exercise; Endurance exercise at 60-65% HR max, 4x/wk for 6 months.	Behavioral: Moderate Exercise; Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise [ Time Frame: 9 to 26 weeks ]
   To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.

Secondary Outcome Measures :

1. 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score [ Time Frame: Baseline and 6 months ]
   Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.

Other Outcome Measures:

1. Number of Days of Exercise Per Week [ Time Frame: 9 to 26 weeks ]
   The number of days the participant exercised per week

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Clinical diagnosis of primary Parkinson's disease
• 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:

• Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
• 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

Contacts and Locations

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Locations

United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Illinois
University of Illinois, Chicago
Chicago, Illinois, United States, 60612
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Colorado, Denver

University of Illinois at Chicago

University of Pittsburgh

Rush University Medical Center

National Institute of Neurological Disorders and Stroke (NINDS)

Northwestern University

Investigators

Principal Investigator:	Margaret Schenkman, PT, PhD	University of Colorado, Denver
Principal Investigator:	Daniel Corcos, PhD	University of Illinois at Chicago

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT01506479 History of Changes
Other Study ID Numbers:	11-1237; R01NS074343 ( U.S. NIH Grant/Contract )
First Posted:	January 10, 2012
Results First Posted:	October 13, 2017
Last Update Posted:	October 13, 2017
Last Verified:	September 2017

Keywords provided by University of Colorado, Denver:

Parkinson Disease; Basal Ganglia Disease; Central Nervous System Diseases; Nervous System Diseases	Movement Disorders; Neurodegenerative Diseases; Brain Diseases

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases