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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
Sponsor:
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

Study Type: Interventional
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Prescreening by telephone and for patients in movement disorder clinics from May 2012 to November 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Control Group

Wait listed to moderate or vigorous exercise after 6 months of no exercise.

No Intervention: No-exercise control (i.e., usual care);
Vigorous Exercise

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.
Moderate Exercise

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.

Participant Flow:   Overall Study
    Control Group   Vigorous Exercise   Moderate Exercise
STARTED   40   43   45 
COMPLETED [1]   37   38   42 
NOT COMPLETED   3   5   3 
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.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group

Wait listed to moderate or vigorous exercise after 6 months of no exercise.

No Intervention: No-exercise control (i.e., usual care);
Vigorous Exercise

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.
Moderate Exercise

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 Total of all reporting groups

Baseline Measures
   Control Group   Vigorous Exercise   Moderate Exercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 40   43   45   128 
Age 
[Units: Years]
Mean (Standard Deviation) 		       
Participants Analyzed 
[Units: Participants]
 		 40   43   45   128 
   64  (10)   64  (9)   63  (10)   64  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Participants Analyzed 
[Units: Participants]
 		 40   43   45   128 
Female      16  40.0%      21  48.8%      18  40.0%      55  43.0% 
Male      24  60.0%      22  51.2%      27  60.0%      73  57.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		       
Participants Analyzed 
[Units: Participants]
 		 40   43   45   128 
Hispanic or Latino      1   2.5%      3   7.0%      2   4.4%      6   4.7% 
Not Hispanic or Latino      39  97.5%      39  90.7%      41  91.1%      119  93.0% 
Unknown or Not Reported      0   0.0%      1   2.3%      2   4.4%      3   2.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		       
Participants Analyzed 
[Units: Participants]
 		 40   43   45   128 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      2   5.0%      2   4.7%      2   4.4%      6   4.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   5.0%      1   2.3%      2   4.4%      5   3.9% 
White      36  90.0%      39  90.7%      40  88.9%      115  89.8% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   2.3%      1   2.2%      2   1.6% 
Unified Parkinson Disease Rating Scale Part 3 Motor Evaluation [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		       
Participants Analyzed 
[Units: Participants]
 		 40   43   45   128 
   17  (7)   17  (7)   16  (7)   17  (7) 
[1] Sum of 27 items scored 0 to 4, minimum score is 0, maximum score is 108. Higher score indicates worse motor symptoms.
Total daily steps [1] 
[Units: Steps per day]
Mean (Standard Deviation) 		       
Participants Analyzed 
[Units: Participants]
 		 36   36   42   114 
   5005  (2987)   5146  (3107)   5702  (2521)   5306  (2856) 
[1] Several participants did not wear the activity monitor devices for recording total number of daily steps.
Hoehn and Yahr Stage [1] 
[Units: Participants]
Count of Participants 		       
Participants Analyzed 
[Units: Participants]
 		 40   43   45   128 
Stage 1      8  20.0%      12  27.9%      13  28.9%      33  25.8% 
Stage 2      32  80.0%      31  72.1%      32  71.1%      95  74.2% 
[1] Stage 1 is Unilateral Disease; Stage 2 is Bilateral Disease without impairment of balance


  Outcome Measures

1.  Primary:   Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise   [ Time Frame: 9 to 26 weeks ]
  Show Outcome Measure 1

2.  Secondary:   6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score   [ Time Frame: Baseline and 6 months ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Number of Days of Exercise Per Week   [ Time Frame: 9 to 26 weeks ]
  Show Outcome Measure 3


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Charity G. Moore
Organization: University of Pittsburgh
phone: 412-383-6630
e-mail: cgp22@pitt.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01506479     History of Changes
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