Study in Parkinson's Disease of Exercise

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Moderate Exercise
* Behavioral: Vigorous Exercise
* Behavioral: No Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Group<br>Wait listed to moderate or vigorous exercise after 6 months of no exercise. | Behavioral: No Intervention<br>* No-exercise control (i.e., usual care);<br>|
| Experimental: Vigorous Exercise<br>Endurance exercise at 80-85% HR max, 4x/wk for 6 months. | Behavioral: Vigorous Exercise<br>* Endurance exercise at 80-85% HR max, 4x/wk for 6 months.<br>|
| Experimental: Moderate Exercise<br>Endurance exercise at 60-65% HR max, 4x/wk for 6 months. | Behavioral: Moderate Exercise<br>* Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise | 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. | 9 to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score | 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. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Basal Ganglia Disease, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Brain Diseases