Study in Parkinson's Disease of Exercise (SPARX)
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ClinicalTrials.gov Identifier: NCT01506479 |
Recruitment Status :
Completed
First Posted : January 10, 2012
Results First Posted : October 13, 2017
Last Update Posted : October 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Behavioral: Moderate Exercise Behavioral: Vigorous Exercise Behavioral: No Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease |
Actual Study Start Date : | May 2012 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | November 2016 |

Arm | Intervention/treatment |
---|---|
Sham Comparator: Control Group
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
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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.
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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. |
- 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.
- 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.
- Number of Days of Exercise Per Week [ Time Frame: 9 to 26 weeks ]The number of days the participant exercised per week

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506479
United States, Colorado | |
University of Colorado Denver | |
Aurora, Colorado, United States, 80045 | |
United States, Illinois | |
University of Illinois, Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Margaret Schenkman, PT, PhD | University of Colorado, Denver | |
Principal Investigator: | Daniel Corcos, PhD | University of Illinois at Chicago |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01506479 |
Other Study ID Numbers: |
11-1237 R01NS074343 ( U.S. NIH Grant/Contract ) |
First Posted: | January 10, 2012 Key Record Dates |
Results First Posted: | October 13, 2017 |
Last Update Posted: | October 13, 2017 |
Last Verified: | September 2017 |
Parkinson Disease Basal Ganglia Disease Central Nervous System Diseases Nervous System Diseases |
Movement Disorders Neurodegenerative Diseases Brain Diseases |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |