Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 128
- Locations
- 3
- Primary Endpoint
- Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- 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
Arms & Interventions
Vigorous Exercise
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Intervention: Vigorous Exercise (Behavioral)
Moderate Exercise
Endurance exercise at 60-65% HR max, 4x/wk for 6 months.
Intervention: Moderate Exercise (Behavioral)
Control Group
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
Intervention: No Intervention (Behavioral)
Outcomes
Primary Outcomes
Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise
Time Frame: 9 to 26 weeks
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.
Secondary Outcomes
- 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score(Baseline and 6 months)