Boston, Massachusetts 02114


Purpose:

Forced cadence cycling (FCC) in which individuals with Parkinson's Disease (PD) pedal with external augmentation at 80-90 revolutions per minute (rpm) has demonstrated significant motor improvement in prior clinical trials. These studies required either a tandem bicycle with second rider or an expensive motorized bicycle, making this therapy inaccessible to most patients. In this pragmatic open-label before and after pilot study investigators examine implementation and effectiveness of (RCC) without tandem or motor augmentation and in a community-based setting. Approximately 30 participants will be recruited to participate in 24 one-hour rapid-cadence spin classes in YMCAs over 8 weeks. Primary outcomes will examine implementation of the intervention and secondary outcomes will examine effectiveness against a historical comparison group.


Criteria:

Inclusion Criteria: 1. Adults age 18 or older. 2. Clinically confirmed diagnosis of idiopathic PD by a movement disorder specialist. 3. Hoehn and Yahr stage I-III while ON anti-parkinsonian medication. 4. Stable or absent MAO-B inhibitors (Selegiline, Rasagiline, Zydis selegiline HCL Oral disintegrating) for at least 60 days prior to enrollment; stable or absent other medications for PD motor symptoms (Levodopa, Dopamine agonists, Anticholinergics, Amantadine, COMT-Inhibitors) for at least 30 days prior to enrollment; stable or absent medications for the following PD-non-motor symptoms: depression, anxiety, cognition, sleep, orthostatic hypotension. 5. Agreement to defer any medication changes until after completion of 8-week program and post-test measurements. 6. Written permission by a physician to participate in the program. 7. English language proficiency sufficient to understand and participate in a cycling class taught in English. Exclusion Criteria: 1. Clinically significant medical disease that would increase the risk of exercise-related complications (eg: cardiac or pulmonary disease, uncontrolled diabetes mellitus, uncontrolled hypertension or stroke) as determined by a treating physician through letter obtained by YMCA or the study investigator. 2. Dementia as evidenced by a score of less than 116 on the Mattis Dementia Rating Scale or dementia in the opinion of the study investigator that would prohibit subject from complying with all study activities. 3. Other medical or musculoskeletal contraindication to exercise. 4. Concurrent participation in another trial of exercise therapy for PD or initiation of a new structured exercise plan during the duration of the study. Note: participants may continue any pre-existing exercise routine (including group-based classes) during the study but will be asked not to start anything new.


NCT ID:

NCT03675932


Primary Contact:

Principal Investigator
Anne-Marie Wills, MD, MPH
Massachusetts General Hospital

Remy Johnson, BA
Phone: 617-726-4936
Email: rkjohnson@mgh.harvard.edu


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States

Remy Johnson, BA
Phone: 617-726-4936
Email: rkjohnson@mgh.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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