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

NCT03675932 | Completed

• 1 other identifier: 2018P001116
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percentage of individuals who complete at least 80% of offered cycling sessions [Tolerability]

  Investigators will consider those who do not withdraw from the study, are not lost to follow up, and complete at least 80% of the cycling sessions to demonstrate tolerability of the study.

  assessed at conclusion of the 8 week intervention

• Proportion of subjects reporting an adverse event during class [Safety]

  Safety will be reported descriptively and include the proportion of subjects reporting any adverse event.

  assessed at each class by study staff and weekly by PI for duration of 8 week intervention

Secondary Outcomes (5)

• Modified Unified Parkinson's Disease Rating Scale-section III Motor

  Assessed within two weeks prior to start of intervention and within one week after completion of intervention

• Timed Up and Go

  Assessed within two weeks prior to start of intervention and within one week after completion of intervention

• Trail Making Test A& B

  Assessed within two weeks prior to start of intervention and within one week after completion of intervention

• PROMIS sf v1.0 Global Health

  Assessed within two weeks prior to start of intervention and within one week after completion of intervention

• Assessment of Intelligibility of Dysarthria (AIDS)

  Assessed within two weeks prior to start of intervention and within one week after completion of intervention

Study Arms (1)

Cycling Intervention

EXPERIMENTAL

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

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

Interventions

Rapid Cadence Cycling on a Solo-Rider Spin Bicycle 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.

Cycling Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 or older.
• Clinically confirmed diagnosis of idiopathic PD by a movement disorder specialist.
• Hoehn and Yahr stage I-III while ON anti-parkinsonian medication.
• 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.
• Agreement to defer any medication changes until after completion of 8-week program and post-test measurements.
• Written permission by a physician to participate in the program.
• English language proficiency sufficient to understand and participate in a cycling class taught in English.

You may not qualify if:

• 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.
• 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.
• Other medical or musculoskeletal contraindication to exercise.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Anne-Marie Wills, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Kathleen E McKee, MD

  Massacusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Neurology

Study Record Dates

• First Submitted: September 8, 2018
• First Posted: September 18, 2018
• Study Start: October 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)