Back to resultsRapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rapid Cadence Cycling on a Solo-Rider Spin Bicycle
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cycling Intervention
Arm Description
Single-arm trial. All participants will receive the same intervention of Rapid Cadence Cycling on a Solo-Rider Spin Bicycle
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Modified Unified Parkinson's Disease Rating Scale-section III Motor
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).
Timed Up and Go
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
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
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.
Assessment of Intelligibility of Dysarthria (AIDS)
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.
Full Information
NCT ID
NCT03675932
First Posted
September 8, 2018
Last Updated
February 24, 2020
Sponsor
Massachusetts General Hospital
Collaborators
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03675932
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cycling Intervention
Arm Type
Experimental
Arm Description
Single-arm trial. All participants will receive the same intervention of Rapid Cadence Cycling on a Solo-Rider Spin Bicycle
Intervention Type
Other
Intervention Name(s)
Rapid Cadence Cycling on a Solo-Rider Spin Bicycle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of individuals who complete at least 80% of offered cycling sessions [Tolerability]
Description
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.
Time Frame
assessed at conclusion of the 8 week intervention
Title
Proportion of subjects reporting an adverse event during class [Safety]
Description
Safety will be reported descriptively and include the proportion of subjects reporting any adverse event.
Time Frame
assessed at each class by study staff and weekly by PI for duration of 8 week intervention
Secondary Outcome Measure Information:
Title
Modified Unified Parkinson's Disease Rating Scale-section III Motor
Description
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).
Time Frame
Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Title
Timed Up and Go
Description
The Timed Up and Go test is measured in seconds with a range of 5-25 seconds (longer is worse)
Time Frame
Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Title
Trail Making Test A& B
Description
This cognitive test is measured in seconds with a range (part B) of 60-240 seconds (longer is worse).
Time Frame
Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Title
PROMIS sf v1.0 Global Health
Description
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.
Time Frame
Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Title
Assessment of Intelligibility of Dysarthria (AIDS)
Description
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.
Time Frame
Assessed within two weeks prior to start of intervention and within one week after completion of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Wills, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen E McKee, MD
Organizational Affiliation
Massacusetts General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
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