Study in Parkinson's Disease of Exercise (SPARX)

This study is currently recruiting participants.

Verified February 2013 by University of Colorado, Denver

Sponsor:

Collaborators:

University of Illinois

University of Pittsburgh

Rush University Medical Center

National Institute of Neurological Disorders and Stroke (NINDS)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 16, 2011

Last Updated Date

February 27, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

June 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01506479 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Study Arm (s)

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

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

126

Estimated Completion Date

August 2015

Estimated Primary Completion Date

June 2015 (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

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01506479

Other Study ID Numbers ^ICMJE

11-1237, R01NS074343

Has Data Monitoring Committee

Yes

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

University of Illinois
University of Pittsburgh
Rush University Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:	Margaret Schenkman, PT, PhD	University of Colorado, Denver
Principal Investigator:	Daniel Corcos, PhD	University of Illinois

Information Provided By

University of Colorado, Denver

Verification Date

February 2013

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

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