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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Rapid Cadence Cycling on a Solo-Rider Spin Bicycle

• Registration Number: NCT03675932
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-08
• Study First Submitted QC: 2018-09-16
• Study First Posted: 2018-09-18
• Study Start: 2018-10-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-08-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of individuals who complete at least 80% of offered cycling sessions [Tolerability]	assessed at conclusion of the 8 week intervention	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.
Proportion of subjects reporting an adverse event during class [Safety]	assessed at each class by study staff and weekly by PI for duration of 8 week intervention	Safety will be reported descriptively and include the proportion of subjects reporting any adverse event.

Secondary Outcome Measures

Name	Time	Method
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	The Unified Parkinson's Disease Rating Scale (UPDRS) section III measures severity of motor symptoms of Parkinson's disease with scores ranging from 0 to 199 with higher scores indicating more severe motor symptoms. This study utilizes a modified version of the UPDRS without rigidity which will be recorded on video and rated remotely by a movement disorder neurologist blinded to intervention status of the participant. This modified version has been shown to be reliable and valid, both at cross-sectional time points and longitudinally (Abdolahi, 2013).
Assessment of Intelligibility of Dysarthria (AIDS)	Assessed within two weeks prior to start of intervention and within one week after completion of intervention	The Assessment of Intelligibility of Dysarthric Speech is a tool for quantifying single-word intelligibility, sentence intelligibility, and speaking rate. The outcome is measured as the percent of words that are intelligible, with higher scores being better.
Timed Up and Go	Assessed within two weeks prior to start of intervention and within one week after completion of intervention	The Timed Up and Go test is measured in seconds with a range of 5-25 seconds (longer is worse)
Trail Making Test A& B	Assessed within two weeks prior to start of intervention and within one week after completion of intervention	This cognitive test is measured in seconds with a range (part B) of 60-240 seconds (longer is worse).
PROMIS sf v1.0 Global Health	Assessed within two weeks prior to start of intervention and within one week after completion of intervention	A 10-item patient reported outcomes scale measuring five domains (physical function, fatigue, pain, emotional distress, social health) and general health perceptions that cut across domains. Scores can range from 0-100 where higher is better.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States