Study in Parkinson's Disease of Exercise (SPARX)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: No Intervention; Behavioral: Vigorous Exercise; Behavioral: Moderate Exercise

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: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois, Chicago
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Group; Wait listed to moderate or vigorous exercise after 6 months of no exercise.	Behavioral: No Intervention; No-exercise control (i.e., usual care);
Experimental: Vigorous Exercise; Endurance exercise at 80-85% HR max, 4x/wk for 6 months.	Behavioral: Vigorous Exercise; Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Experimental: Moderate Exercise; Endurance exercise at 60-65% HR max, 4x/wk for 6 months.	Behavioral: Moderate Exercise; Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise	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.	9 to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score	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.	Baseline and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days of Exercise Per Week	The number of days the participant exercised per week	9 to 26 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Northwestern University; National Institute of Neurological Disorders and Stroke (NINDS); University of Pittsburgh; University of Illinois at Chicago; 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

Publications and helpful links

General Publications

• Hall DA, Moore C, Comella C; SPARX Study Group. Recruitment of patients with de novo Parkinson disease: successful strategies in a randomized exercise clinical trial. Trials. 2018 Nov 14;19(1):630. doi: 10.1186/s13063-018-2958-z.
• Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 16, 2011
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Movement Disorders; Parkinson Disease; Central Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases; Basal Ganglia Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 11-1237; R01NS074343 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No