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

Participant Flow

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
Arm/Group Description	Wait listed to moderate or vigorous...	Endurance exercise at 80-85% HR max...	Endurance exercise at 60-65% HR max...
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.

Baseline Characteristics

Arm/Group Title		Control Group	Vigorous Exercise	Moderate Exercise	Total
Arm/Group Description		Wait listed to moderate or vigorous...	Endurance exercise at 80-85% HR max...	Endurance exercise at 60-65% HR max...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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

Outcome Measures

1.Primary Outcome


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 (naï...
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

Outcome Measure Data

Analysis Population Description

Only for participants who contributed heart rate monitor data.


Arm/Group Title	Vigorous Exercise	Moderate Exercise
Arm/Group Description:	Endurance exercise at 80-85% HR max...	Endurance exercise at 60-65% HR max...
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)

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
Description	Participants were assessed at baseline and at 6 months on their UPDRS....
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

Outcome Measure Data

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
Arm/Group Description:	Wait listed to moderate or vigorous...	Endurance exercise at 80-85% HR max...	Endurance exercise at 60-65% HR max...
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)

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]

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
Description	The number of days the participant exercised per week
Description	The number of days the participant exercised per week
Time Frame	9 to 26 weeks

Outcome Measure Data

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
Arm/Group Description:	Endurance exercise at 80-85% HR max...	Endurance exercise at 60-65% HR max...
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)

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]

Adverse Events

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
Arm/Group Description	Wait listed to moderate or vigorous...		Endurance exercise at 80-85% HR max...		Endurance exercise at 60-65% HR max...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

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

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

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

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.

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.

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.

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

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