Back to resultsStudy in Parkinson's Disease of Exercise (SPARX)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate Exercise
Vigorous Exercise
No Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Basal Ganglia Disease, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases
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
Sites / Locations
- University of Colorado Denver
- University of Illinois, Chicago
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
Control Group
Vigorous Exercise
Moderate Exercise
Arm Description
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Endurance exercise at 60-65% HR max, 4x/wk for 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01506479
First Posted
December 16, 2011
Last Updated
September 12, 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
1. Study Identification
Unique Protocol Identification Number
NCT01506479
Brief Title
Study in Parkinson's Disease of Exercise
Acronym
SPARX
Official Title
Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Basal Ganglia Disease, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
Arm Title
Vigorous Exercise
Arm Type
Experimental
Arm Description
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Arm Title
Moderate Exercise
Arm Type
Experimental
Arm Description
Endurance exercise at 60-65% HR max, 4x/wk for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Moderate Exercise
Intervention Description
Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Vigorous Exercise
Intervention Description
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
No Intervention
Intervention Description
No-exercise control (i.e., usual care);
Primary Outcome Measure Information:
Title
Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise
Description
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.
Time Frame
9 to 26 weeks
Secondary Outcome Measure Information:
Title
6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
Description
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.
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Number of Days of Exercise Per Week
Description
The number of days the participant exercised per week
Time Frame
9 to 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Schenkman, PT, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Corcos, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Illinois, Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30428907
Citation
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.
Results Reference
derived
PubMed Identifier
29228079
Citation
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.
Results Reference
derived
PubMed Identifier
23770108
Citation
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.
Results Reference
derived
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Study in Parkinson's Disease of Exercise
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