Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-06 @ 4:02 PM
Study NCT ID:
NCT03675932
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2018-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: