Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
Status: | Recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 100 |
Updated: | 3/8/2019 |
Start Date: | October 1, 2018 |
End Date: | July 1, 2019 |
Contact: | Remy Johnson, BA |
Email: | rkjohnson@mgh.harvard.edu |
Phone: | 617-726-4936 |
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.
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.
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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-4936
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