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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

Tracking Information
First Submitted Date  ICMJE December 16, 2011
First Posted Date  ICMJE January 10, 2012
Results First Submitted Date  ICMJE June 23, 2017
Results First Posted Date  ICMJE October 13, 2017
Last Update Posted Date October 13, 2017
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
Adherence to exercise [ Time Frame: 6 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
Potential for therapeutic efficacy [ Time Frame: 6 months ]
To determine if intense endurance exercise warrants further investigation as a therapeutic intervention for motor symptoms in the treatment of de novo Parkinson's disease by conducting a futility trial. The exercise groups will demonstrate potential for therapeutic efficacy using a futility threshold of theta = 3.5 points on the UPDRS motor scale at 6 months when compared with the no exercise control group who are wait-listed to then receive treatment. The incidence of adverse events and 6-month attrition associated with the exercise groups will also be evaluated.
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2017)
Number of Days of Exercise Per Week [ Time Frame: 9 to 26 weeks ]
The number of days the participant exercised per week
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Parkinson's Disease of Exercise
Official Title  ICMJE Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Behavioral: Moderate Exercise
    Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
  • Behavioral: Vigorous Exercise
    Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
  • Behavioral: No Intervention
    No-exercise control (i.e., usual care);
Study Arms  ICMJE
  • Sham Comparator: Control Group
    Wait listed to moderate or vigorous exercise after 6 months of no exercise.
    Intervention: Behavioral: No Intervention
  • Experimental: Vigorous Exercise
    Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
    Intervention: Behavioral: Vigorous Exercise
  • Experimental: Moderate Exercise
    Endurance exercise at 60-65% HR max, 4x/wk for 6 months.
    Intervention: Behavioral: Moderate Exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2017)
128
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2012)
126
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01506479
Other Study ID Numbers  ICMJE 11-1237
R01NS074343 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • University of Illinois at Chicago
  • University of Pittsburgh
  • Rush University Medical Center
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Northwestern University
Investigators  ICMJE
Principal Investigator: Margaret Schenkman, PT, PhD University of Colorado, Denver
Principal Investigator: Daniel Corcos, PhD University of Illinois at Chicago
PRS Account University of Colorado, Denver
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP