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Study in Parkinson's Disease of Exercise (SPARX)

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ClinicalTrials.gov Identifier: NCT01506479
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborators:
University of Illinois at Chicago
University of Pittsburgh
Rush University Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Northwestern University
Information provided by (Responsible Party):
University of Colorado, Denver

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

Resource links provided by the National Library of Medicine


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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506479


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):

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    Key Record Dates
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