Parkinson Disease
Conditions
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.
Interventions
OTHERRapid Cadence Cycling on a Solo-Rider Spin Bicycle
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.
Sponsors
The Cleveland Clinic
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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) |
Countries
United States
Outcome results
None listed