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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
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
Hide Arm/Group Description

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.
Arm/Group Title Control Group Vigorous Exercise Moderate Exercise Total
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 40 participants 43 participants 45 participants 128 participants
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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 45 participants 128 participants
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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 45 participants 128 participants
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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
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.
Total daily steps   [1] 
Mean (Standard Deviation)
Unit of measure:  Steps per day
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.
Hoehn and Yahr Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 45 participants 128 participants
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]
Measure Description: Stage 1 is Unilateral Disease; Stage 2 is Bilateral Disease without impairment of balance
1.Primary Outcome
Title Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only for participants who contributed heart rate monitor data.
Arm/Group Title Vigorous Exercise Moderate Exercise
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 38 42
Mean (95% Confidence Interval)
Unit of Measure: percentage of maximum heart rate
80.3
(78.8 to 81.7)
65.9
(64.2 to 67.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vigorous Exercise, Moderate Exercise
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.3
Confidence Interval (2-Sided) 95%
12.0 to 16.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat; participants were analyzed in the group to which they were assigned. If a participant started medication, the UPDRS measure prior to initiating medication was used even if the 6 month data were not collected. Participants who did not start medications and were missing the 6 month assessment were not included.
Arm/Group Title Control Group Vigorous Exercise Moderate Exercise
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 38 39 42
Mean (95% Confidence Interval)
Unit of Measure: units on the UPDRS Motor scale
3.2
(1.4 to 5.1)
0.3
(-1.7 to 2.3)
2.0
(0.4 to 3.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Vigorous Exercise
Comments The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments The a priori threshold for statistical significance was 0.10
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.9
Confidence Interval (1-Sided) 90%
4.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Moderate Exercise
Comments The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation .
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation).
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (1-Sided) 90%
2.8
Estimation Comments

The estimate is the difference between the control group and the moderate exercise group.

The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis.

3.Other Pre-specified Outcome
Title Number of Days of Exercise Per Week
Hide Description The number of days the participant exercised per week
Time Frame 9 to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were analyzed in the group to which they were assigned. Participants were not included if they did not start the intervention.
Arm/Group Title Vigorous Exercise Moderate Exercise
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 40 45
Mean (95% Confidence Interval)
Unit of Measure: Number of days per week
2.8
(2.4 to 3.2)
3.2
(2.8 to 3.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vigorous Exercise, Moderate Exercise
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1334
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse event data were collected monthly until the primary time point at 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Vigorous Exercise Moderate Exercise
Hide Arm/Group Description

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.

All-Cause Mortality
Control Group Vigorous Exercise Moderate Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/43 (0.00%)      0/45 (0.00%)    
Hide Serious Adverse Events
Control Group Vigorous Exercise Moderate Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/43 (0.00%)      2/45 (4.44%)    
Gastrointestinal disorders       
Gastric ulcer  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Renal and urinary disorders       
Renal calculi  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Vigorous Exercise Moderate Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/40 (32.50%)      28/43 (65.12%)      24/45 (53.33%)    
Blood and lymphatic system disorders       
Blood and lymphatic system disorders - Other, specify  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Cardiac disorders       
Palpitations  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Gastrointestinal disorders       
Diarrhea  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Gastric ulcer  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Gastrointestinal disorders - Other, specify  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
General disorders       
Flu like symptoms  1  0/40 (0.00%)  0 2/43 (4.65%)  2 0/45 (0.00%)  0
Flu like symptoms  1  0/40 (0.00%)  0 0/43 (0.00%)  0 3/45 (6.67%)  3
Infections and infestations       
Bladder infection  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Lung infection  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Rhinitis infective  1  1/40 (2.50%)  1 0/43 (0.00%)  0 0/45 (0.00%)  0
Skin infection  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Upper respiratory infection  1  1/40 (2.50%)  1 3/43 (6.98%)  3 0/45 (0.00%)  0
Urinary tract infection  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Urinary tract infection  1  0/40 (0.00%)  0 0/43 (0.00%)  0 2/45 (4.44%)  2
Injury, poisoning and procedural complications       
Fall  1  9/40 (22.50%)  11 6/43 (13.95%)  13 5/45 (11.11%)  7
Injury, poisoning and procedural complications - Other, specify  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Injury, poisoning and procedural complications - Other, specify  1  0/40 (0.00%)  0 0/43 (0.00%)  0 3/45 (6.67%)  3
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/40 (0.00%)  0 2/43 (4.65%)  2 0/45 (0.00%)  0
Arthritis  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Back pain  1  0/40 (0.00%)  0 4/43 (9.30%)  4 0/45 (0.00%)  0
Buttock pain  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Myalgia  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Neck pain  1  1/40 (2.50%)  1 0/43 (0.00%)  0 1/45 (2.22%)  1
Pain in extremity  1  1/40 (2.50%)  1 8/43 (18.60%)  9 3/45 (6.67%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/40 (2.50%)  1 0/43 (0.00%)  0 1/45 (2.22%)  1
Nervous system disorders       
Nervous system disorders - Other, specify  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Renal and urinary disorders       
Renal calculi  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Urine discoloration  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/40 (2.50%)  1 1/43 (2.33%)  1 1/45 (2.22%)  1
Sore throat  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dry skin  1  1/40 (2.50%)  1 0/43 (0.00%)  0 0/45 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1  1/40 (2.50%)  1 0/43 (0.00%)  0 1/45 (2.22%)  1
Surgical and medical procedures       
Surgical and medical procedures - Other, specify  1  1/40 (2.50%)  1 0/43 (0.00%)  0 3/45 (6.67%)  3
Vascular disorders       
Hypertension  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/45 (0.00%)  0
Hypertension  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/45 (2.22%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Charity G. Moore
Organization: University of Pittsburgh
Phone: 412-383-6630
EMail: cgp22@pitt.edu
Layout table for additonal information
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