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
  Purpose

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 Intervention Phase
Parkinson Disease
Behavioral: Moderate Exercise
Behavioral: Vigorous Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 126
Study Start Date: April 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
Experimental: Vigorous Exercise Behavioral: Vigorous Exercise
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Experimental: Moderate Exercise Behavioral: Moderate Exercise
Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506479

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Toby Wellington, BS    720-848-6376    toby.wellington@ucdenver.edu   
Principal Investigator: Margaret Schenkman, PT, PhD         
United States, Illinois
University of Illinois, Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Lucy Blasucci, RN    312-563-2184    lucia_m_blasucci@rush.edu   
Principal Investigator: Daniel Corcos, PhD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Samannaaz Khoja, PT    412-383-6868    ssk21@pitt.edu   
Principal Investigator: Tony Delitto, PT, PhD         
Sponsors and Collaborators
University of Colorado, Denver
University of Illinois at Chicago
University of Pittsburgh
Rush University Medical Center
Investigators
Principal Investigator: Margaret Schenkman, PT, PhD University of Colorado, Denver
Principal Investigator: Daniel Corcos, PhD University of Illinois at Chicago
  More Information

No publications provided by University of Colorado, Denver

Additional 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
Study First Received: December 16, 2011
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 10, 2014