N/A
N=128
Study in Parkinson's Disease of Exercise
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT01506479 ↗Enrolled (actual)
128
Serious AEs
1.6%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise — 80.3; 65.9 percentage of maximum heart rate — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Moderate Exercise (Behavioral); Vigorous Exercise (Behavioral); No Intervention (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise |
80.3; 65.9 | <0.0001 sig |
| SECONDARY 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score |
3.2; 0.3; 2.0 | 0.34 |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT01506479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.