Parkinson DiseaseNCT03675932
Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
A study testing Rapid Cadence Cycling on a Solo-Rider Spin Bicycle in people with Parkinson Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rapid Cadence Cycling on a Solo-Rider Spin Bicycle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Rapid Cadence Cycling on a Solo-Rider Spin Bicycle
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Cadence Cycling on a Solo-Rider Spin BicycleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cycling Intervention | Experimental | Single-arm trial. All participants will receive the same intervention of Rapid Cadence Cycling on a Solo-Rider Spin Bicycle Receives: Other: Rapid Cadence Cycling on a Solo-Rider Spin Bicycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: assessed at each class by study staff and weekly by PI for duration of 8 week intervention
Secondary outcomes (5)
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).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Oct 2018
- Primary completion1 May 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital
- Investigators
- Anne-Marie Wills, MD, MPH, Principal investigator, Massachusetts General HospitalKathleen E McKee, MD, Study director, Massacusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675932
- Sponsor's protocol ID
- 2018P001116
- Status last verified
- Feb 2020
- First submitted
- 8 Sep 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
- ClinicalTrials.gov ID
- NCT03675932
- Acronym / sponsor ID
- 2018P001116
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cycling Intervention | Experimental | Other: Rapid Cadence Cycling on a Solo-Rider Spin BicycleSingle-arm trial. All participants will receive the same intervention of Rapid Cadence Cycling on a Solo-Rider Spin Bicycle |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Cadence Cycling on a Solo-Rider Spin BicycleIndividuals 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. | Other | Cycling Intervention |
Primary outcome
Percentage of individuals who complete at least 80% of offered cycling sessions [Tolerability]
Time frame: 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]
Time frame: 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.
5 secondary outcomes
Modified Unified Parkinson's Disease Rating Scale-section III Motor
Time frame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Timed Up and Go
Time frame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Trail Making Test A& B
Time frame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
PROMIS sf v1.0 Global Health
Time frame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Assessment of Intelligibility of Dysarthria (AIDS)
Time frame: Assessed within two weeks prior to start of intervention and within one week after completion of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Marie Wills, MD, MPH principal investigator
Massachusetts General Hospital
Kathleen E McKee, MD study director
Massacusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Cadence Cycling on a Solo-Rider Spin Bicycle in people with Parkinson Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of individuals who complete at least 80% of offered cycling sessions [Tolerability] (time frame: assessed at conclusion of the 8 week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.