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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycling Intervention | Experimental | Single-arm trial. All participants will receive the same intervention of Rapid Cadence Cycling on a Solo-Rider Spin Bicycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie Wills, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Kathleen E McKee, MD | Massacusetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Assessed within two weeks prior to start of intervention and within one week after completion of intervention |
| Timed Up and Go | The Timed Up and Go test is measured in seconds with a range of 5-25 seconds (longer is worse) | Assessed within two weeks prior to start of intervention and within one week after completion of intervention |
| Trail Making Test A& B | This cognitive test is measured in seconds with a range (part B) of 60-240 seconds (longer is worse). | Assessed within two weeks prior to start of intervention and within one week after completion of intervention |
| 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. | Assessed within two weeks prior to start of intervention and within one week after completion of intervention |
| 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. | Assessed within two weeks prior to start of intervention and within one week after completion of intervention |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |