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Study in Parkinson's Disease of Exercise (SPARX)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506479
First Posted: January 10, 2012
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
December 16, 2011
January 10, 2012
June 23, 2017
October 13, 2017
October 13, 2017
May 2012
November 2016   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01506479 on ClinicalTrials.gov Archive Site
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.
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.

Number of Days of Exercise Per Week [ Time Frame: 9 to 26 weeks ]
The number of days the participant exercised per week
Not Provided
 
Study in Parkinson's Disease of Exercise
Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Parkinson Disease
  • 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);
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
November 2016
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01506479
11-1237
R01NS074343 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Colorado, Denver
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
Principal Investigator: Margaret Schenkman, PT, PhD University of Colorado, Denver
Principal Investigator: Daniel Corcos, PhD University of Illinois at Chicago
University of Colorado, Denver
September 2017

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