Study in Parkinson's Disease of Exercise (SPARX)

• ClinicalTrials.gov Identifier: NCT01506479
• Recruitment Status: Completed
• First Posted: January 10, 2012
• Results First Posted: October 13, 2017
• Last Update Posted: October 13, 2017
• Sponsor: University of Colorado, Denver
• 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

Tracking Information

• First Submitted Date: December 16, 2011
• First Posted Date: January 10, 2012
• Results First Submitted Date: June 23, 2017
• Results First Posted Date: October 13, 2017
• Last Update Posted Date: October 13, 2017
• Actual Study Start Date: May 2012
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2017)

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.

Original Primary Outcome Measures (submitted: January 5, 2012)

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.

Current Secondary Outcome Measures (submitted: September 12, 2017)

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.

Original Secondary Outcome Measures (submitted: January 5, 2012)

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.

Current Other Pre-specified Outcome Measures (submitted: September 12, 2017)

Number of Days of Exercise Per Week [ Time Frame: 9 to 26 weeks ]

The number of days the participant exercised per week

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study in Parkinson's Disease of Exercise
• Official Title: 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 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson Disease

Intervention

• 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);

Study Arms

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2017): 128
• Original Estimated Enrollment (submitted: January 5, 2012): 126
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01506479
• Other Study ID Numbers: 11-1237; R01NS074343 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Colorado, Denver
• Study Sponsor: University of Colorado, Denver

Collaborators

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

Investigators

• Principal Investigator: Margaret Schenkman, PT, PhD; University of Colorado, Denver
• Principal Investigator: Daniel Corcos, PhD; University of Illinois at Chicago

• PRS Account: University of Colorado, Denver
• Verification Date: September 2017