Study in Parkinson's Disease of Exercise (SPARX)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Behavioral: Moderate Exercise Behavioral: Vigorous Exercise |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease |
- Adherence to exercise [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Potential for therapeutic efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To determine if intense endurance exercise warrants further investigation as a therapeutic intervention for motor symptoms in the treatment of de novo Parkinson's disease by conducting a futility trial.
The exercise groups will demonstrate potential for therapeutic efficacy using a futility threshold of theta = 3.5 points on the Unified Parkinson's Disease Rating Scale(UPDRS)motor scale at 6 months when compared with the no exercise control group who are wait-listed to then receive treatment. The incidence of adverse events and 6-month attrition associated with the exercise groups will also be evaluated.
| Estimated Enrollment: | 126 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control Group
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
|
|
| Experimental: Vigorous Exercise |
Behavioral: Vigorous Exercise
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
|
| Experimental: Moderate Exercise |
Behavioral: Moderate Exercise
Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
|
Detailed Description:
The overall objective of this Phase II study is to determine the futility or non-futility of conducting a Phase III 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| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Colorado | |
| University of Colorado Denver | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Toby Wellington, BS 720-848-6376 toby.wellington@ucdenver.edu | |
| Principal Investigator: Margaret Schenkman, PT, PhD | |
| United States, Illinois | |
| University of Illinois, Chicago | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Lucy Blasucci, RN 312-563-2184 lucia_m_blasucci@rush.edu | |
| Principal Investigator: Daniel Corcos, PhD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Samannaaz Khoja, PT 412-383-6868 ssk21@pitt.edu | |
| Principal Investigator: Tony Delitto, PT, PhD | |
| Principal Investigator: | Margaret Schenkman, PT, PhD | University of Colorado, Denver |
| Principal Investigator: | Daniel Corcos, PhD | University of Illinois |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01506479 History of Changes |
| Other Study ID Numbers: | 11-1237, R01NS074343 |
| Study First Received: | December 16, 2011 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
Parkinson Disease Basal Ganglia Disease Central Nervous System Diseases Nervous System Diseases |
Movement Disorders Neurodegenerative Diseases Brain Diseases |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on June 18, 2013