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Study in Parkinson's Disease of Exercise (SPARX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Colorado, Denver
Sponsor:
Collaborators:
University of Illinois at Chicago
University of Pittsburgh
Rush University Medical Center
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01506479
First received: December 16, 2011
Last updated: February 27, 2013
Last verified: February 2013

December 16, 2011
February 27, 2013
April 2012
June 2015   (final data collection date for primary outcome measure)
Adherence to exercise [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01506479 on ClinicalTrials.gov Archive Site
Potential for therapeutic efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 Unified Parkinson's Disease Rating Scale(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.

Potential for therapeutic efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.

Not Provided
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 Phase II study is to determine the futility or non-futility of conducting a Phase III 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
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
  • No Intervention: Control Group
    Wait listed to moderate or vigorous exercise after 6 months of no exercise.
  • Experimental: Vigorous Exercise
    Intervention: Behavioral: Vigorous Exercise
  • Experimental: Moderate Exercise
    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.
 
Recruiting
126
August 2015
June 2015   (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
Both
40 Years to 80 Years
No
United States
 
NCT01506479
11-1237, R01NS074343
Yes
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)
Principal Investigator: Margaret Schenkman, PT, PhD University of Colorado, Denver
Principal Investigator: Daniel Corcos, PhD University of Illinois at Chicago
University of Colorado, Denver
February 2013

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