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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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Parkinson Disease |
Interventions |
Behavioral: Moderate Exercise Behavioral: Vigorous Exercise Behavioral: No Intervention |
Enrollment | 128 |
Recruitment Details | Prescreening by telephone and for patients in movement disorder clinics from May 2012 to November 2015. |
Pre-assignment Details | Screening included confirmation of Parkinson disease diagnosis, assessment of depression and cognition, testing for laboratory measures, and testing for blood pressure and echocardiogram responses to exercise during graded exercise. Once deemed eligible, baseline assessments were completed for disease and non-disease specific scales. |
Arm/Group Title | Control Group | Vigorous Exercise | Moderate Exercise |
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Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); |
Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous 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. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. |
Period Title: Overall Study | |||
Started | 40 | 43 | 45 |
Completed [1] | 37 | 38 | 42 |
Not Completed | 3 | 5 | 3 |
Reason Not Completed | |||
Lost to Follow-up | 1 | 2 | 2 |
Withdrawal by Subject | 1 | 2 | 1 |
Missing assessment | 1 | 0 | 0 |
Adverse Event | 0 | 1 | 0 |
[1]
Number of participants with 6 month follow-up.
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Arm/Group Title | Control Group | Vigorous Exercise | Moderate Exercise | Total | |
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Wait listed to moderate or vigorous exercise after 6 months of no exercise. No Intervention: No-exercise control (i.e., usual care); |
Endurance exercise at 80-85% HR max, 4x/wk for 6 months. Vigorous 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. Moderate Exercise: Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 40 | 43 | 45 | 128 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 40 participants | 43 participants | 45 participants | 128 participants | |
64 (10) | 64 (9) | 63 (10) | 64 (9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 43 participants | 45 participants | 128 participants | |
Female |
16 40.0%
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21 48.8%
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18 40.0%
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55 43.0%
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Male |
24 60.0%
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22 51.2%
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27 60.0%
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73 57.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 43 participants | 45 participants | 128 participants | |
Hispanic or Latino |
1 2.5%
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3 7.0%
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2 4.4%
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6 4.7%
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Not Hispanic or Latino |
39 97.5%
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39 90.7%
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41 91.1%
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119 93.0%
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Unknown or Not Reported |
0 0.0%
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1 2.3%
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2 4.4%
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3 2.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 43 participants | 45 participants | 128 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Asian |
2 5.0%
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2 4.7%
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2 4.4%
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6 4.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 5.0%
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1 2.3%
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2 4.4%
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5 3.9%
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White |
36 90.0%
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39 90.7%
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40 88.9%
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115 89.8%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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1 2.3%
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1 2.2%
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2 1.6%
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Unified Parkinson Disease Rating Scale Part 3 Motor Evaluation
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 40 participants | 43 participants | 45 participants | 128 participants | |
17 (7) | 17 (7) | 16 (7) | 17 (7) | ||
[1]
Measure Description: Sum of 27 items scored 0 to 4, minimum score is 0, maximum score is 108. Higher score indicates worse motor symptoms.
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Total daily steps
[1] Mean (Standard Deviation) Unit of measure: Steps per day |
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Number Analyzed | 36 participants | 36 participants | 42 participants | 114 participants | |
5005 (2987) | 5146 (3107) | 5702 (2521) | 5306 (2856) | ||
[1]
Measure Analysis Population Description: Several participants did not wear the activity monitor devices for recording total number of daily steps.
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Hoehn and Yahr Stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 43 participants | 45 participants | 128 participants | |
Stage 1 |
8 20.0%
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12 27.9%
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13 28.9%
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33 25.8%
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Stage 2 |
32 80.0%
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31 72.1%
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32 71.1%
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95 74.2%
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[1]
Measure Description: Stage 1 is Unilateral Disease; Stage 2 is Bilateral Disease without impairment of balance
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Name/Title: | Dr. Charity G. Moore |
Organization: | University of Pittsburgh |
Phone: | 412-383-6630 |
EMail: | cgp22@pitt.edu |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01506479 |
Other Study ID Numbers: |
11-1237 R01NS074343 ( U.S. NIH Grant/Contract ) |
First Submitted: | December 16, 2011 |
First Posted: | January 10, 2012 |
Results First Submitted: | June 23, 2017 |
Results First Posted: | October 13, 2017 |
Last Update Posted: | October 13, 2017 |