Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting

Mass General Brigham

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Rapid Cadence Cycling on a Solo-Rider Spin Bicycle

Study type: Interventional

Funder types: Other

Identifiers

NCT03675932

2018P001116

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Cycling Intervention

Experimental group

Description:

Single-arm trial. All participants will receive the same intervention of Rapid Cadence Cycling on a Solo-Rider Spin Bicycle

Treatment:

Other: Rapid Cadence Cycling on a Solo-Rider Spin Bicycle