Clinical trial NCT01506479: Study in Parkinson's Disease of Exercise
Official title: Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Basal Ganglia Disease
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Brain Diseases
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: University of Pittsburgh
name: Rush University Medical Center
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Northwestern University
First posted: 2012-01-10
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.

Detailed description: The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise
timeFrame: 9 to 26 weeks
Secondary outcomes:
measure: 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
timeFrame: Baseline and 6 months
Other outcomes:
measure: Number of Days of Exercise Per Week
timeFrame: 9 to 26 weeks
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Chicago
country: United States
facility: University of Illinois, Chicago
state: Illinois
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Colorado, Denver
name: Margaret Schenkman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Daniel Corcos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.