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

NCT ID: NCT03675932

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-08-01

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cycling Intervention

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

Group Type: EXPERIMENTAL

Rapid Cadence Cycling on a Solo-Rider Spin Bicycle

Intervention Type: OTHER

Individuals with Parkinson's Disease will participate in 60 minute spin-classes during which they will follow the Pedaling for Parkinson's(TM) Foundation recommended protocol to achieve a cadence of 80-90 during the 40 minute main set.

Interventions

Rapid Cadence Cycling on a Solo-Rider Spin Bicycle

Individuals with Parkinson's Disease will participate in 60 minute spin-classes during which they will follow the Pedaling for Parkinson's(TM) Foundation recommended protocol to achieve a cadence of 80-90 during the 40 minute main set.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne-Marie Alexandra Wills, MD

Assistant Professor in Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne-Marie Wills, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Kathleen E McKee, MD

Role: STUDY_DIRECTOR

Massacusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2018P001116

Identifier Type: -

Identifier Source: org_study_id