Clinical trial NCT03675932: Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
Official title: Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2018-09-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of individuals who complete at least 80% of offered cycling sessions [Tolerability]
timeFrame: assessed at conclusion of the 8 week intervention
measure: Proportion of subjects reporting an adverse event during class [Safety]
timeFrame: assessed at each class by study staff and weekly by PI for duration of 8 week intervention
Secondary outcomes:
measure: Modified Unified Parkinson's Disease Rating Scale-section III Motor
timeFrame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
measure: Timed Up and Go
timeFrame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
measure: Trail Making Test A& B
timeFrame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
measure: PROMIS sf v1.0 Global Health
timeFrame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
measure: Assessment of Intelligibility of Dysarthria (AIDS)
timeFrame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne-Marie Wills, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massacusetts General Hospital
name: Kathleen E McKee, MD
role: STUDY_DIRECTOR
References: