Parkinson DiseaseSMARTNCT05361200
Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease
A study testing Dynamic high-cadence cycling in people with Parkinson Disease, run by Kent State University at 1 site in United States.
Trial summary
Parkinson's disease (PD) is a progressive neurological disorder that results in slowness of movement, muscle stiffness, tremor, and postural instability. These symptoms significantly affect PD patients' quality of life, independence, and functional performance. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Dynamic high-cadence cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to Dec 2024
- 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 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- 50-79 years of age
- no contraindications to exercise including cardiovascular disease or stroke
Who cannot join
- one or more major signs/symptoms of cardiovascular or pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kent State University
Kent, Ohio, 44242
Ridgel Angela, PhD, 330-672-7495, aridgel@kent.edu
Smith Brittany
About this study
Official title: Effects of Patient-Specific Adaptive Dynamic Cycling on Function Improvement in Individuals With Parkinson's Disease
Parkinson's disease (PD) is a progressive neurological disorder that results in slowness of movement, muscle stiffness, tremor, and postural instability. These symptoms significantly affect PD patients' quality of life, independence, and functional performance. There is currently no cure for PD, but symptoms can be treated with levodopa or deep brain stimulation surgery. Exercise-based rehabilitation has similar beneficial effects to surgical and pharmacological management without the potential negative side effects. Cycling-based interventions have been shown to increases motor function and mobility in individuals with PD. Specifically, benefits are greater when cycling cadence (revolutions per minute, RPM) is 30% greater than a self-selected pace.
Although high cadence cycling improves motor function in individuals with PD, there is significant heterogeneity in individual responses. To maximize the treatment effects and minimize the heterogeneity of high-cadence cycling, it is important to determine patient-specific settings. Previous studies have shown that higher variability (entropy) of cadence leads to greater improvement in motor function. The entropy of cadence calculation will be utilized to understand how patient-specific settings can drive improvements. The purpose of this study is to determine patient-specific settings and measure the effects of high cadence stationary (i.e. dynamic) cycling on functional performance in individuals with PD. Volunteers with Parkinson's disease will complete 12 cycling sessions over a 1-month period and measures of motor function, quality of life, functional performance, mood and exercise readiness will be collected.
Read the detailed description
Potential participants will be prescreened with the ACSM pre-participation questionnaire over the phone or in person. Those who qualify will be asked to visit the research lab and sign the informed consent. Participants will be randomized into one of two groups: 1) patients-specific adaptive dynamic cycling or 2) non-adaptive dynamic cycling. Both groups will participate in a total of 12 sessions, each session consisting of 5 minutes of warm-up, 30 minutes of the main exercise, and 5 minutes of the cool-down period. For the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session. For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.
- Conditions
- Parkinson Disease
- Being tested
- Dynamic high-cadence cycling
- Keywords
- movement disorders, exercise, adaptive therapy, cycling
- Medical subject headings
- Parkinson Disease, Movement Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic high-cadence cyclingBehavioural
Also called S.M.A.R.T. cycling
Resistance settings will be changed based on entropy of cadence every 3 sessions. Cadence will be set at 80RPM for both groups
| Study group | Role | What they receive |
|---|---|---|
| Adaptive dynamic cycling | Experimental | For the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session. Receives: Behavioral: Dynamic high-cadence cycling |
| Non-adaptive dynamic cycling | Active comparator | For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol. Receives: Behavioral: Dynamic high-cadence cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor symptoms
MDS-UPDRS Motor III (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) Minimum Score-0 Maximum Score- 138 Lower score represents improvement
Measured: 4 weeks
Change in motor kinematics
Kinesia One- Accelerometry- Lower score represents milder symptoms
Measured: 4 weeks
Secondary outcomes (2)
Change in quality of life
PDQ-39 (Parkinson' disease quality of life, 39 questions) Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Lower score reflect better QOL Minimum Score- 0 Maximum Score- 156
Measured: 4 weeks
Change in mobility
Timed up and Go- Total time reported, lower time represents greater mobility
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start11 Apr 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study with 2 arms
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Ridgel, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361200
- Sponsor's protocol ID
- SMARTPD
- Acronym
- SMART
- Status last verified
- Feb 2024
- First submitted
- 21 Mar 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harper SA, Dowdell BT, Kim JH, Pollock BS, Ridgel AL. Non-Motor Symptoms after One Week of High Cadence Cycling in Parkinson's Disease. Int J Environ Res Public Health. 2019 Jun 14;16(12):2104. doi: 10.3390/ijerph16122104.
PubMed 31197095Mohammadi-Abdar H, Ridgel AL, Discenzo FM, Loparo KA. Design and Development of a Smart Exercise Bike for Motor Rehabilitation in Individuals with Parkinson's Disease. IEEE ASME Trans Mechatron. 2016 Jun;21(3):1650-1658. doi: 10.1109/TMECH.2015.2508030. Epub 2015 Dec 11.
PubMed 27298575Ridgel AL, Ault DL. High-Cadence Cycling Promotes Sustained Improvement in Bradykinesia, Rigidity, and Mobility in Individuals with Mild-Moderate Parkinson's Disease. Parkinsons Dis. 2019 Mar 3;2019:4076862. doi: 10.1155/2019/4076862. eCollection 2019.
PubMed 30944720Mohammadi-Abdar H, Ridgel AL, Discenzo FM, Phillips RS, Walter BL, Loparo KA. Test and Validation of a Smart Exercise Bike for Motor Rehabilitation in Individuals With Parkinson's Disease. IEEE Trans Neural Syst Rehabil Eng. 2016 Nov;24(11):1254-1264. doi: 10.1109/TNSRE.2016.2549030. Epub 2016 Mar 31.
PubMed 27046905
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Patient-Specific Adaptive Dynamic Cycling on Function Improvement in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05361200
- Acronym / sponsor ID
- SMART / SMARTPD
- Conditions
- Parkinson Disease
- Keywords
- movement disorders, exercise, adaptive therapy, cycling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 May 2022 (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.
Parkinson's disease (PD) is a progressive neurological disorder that results in slowness of movement, muscle stiffness, tremor, and postural instability. These symptoms significantly affect PD patients' quality of life, independence, and functional performance. There is currently no cure for PD, but symptoms can be treated with levodopa or deep brain stimulation surgery. Exercise-based rehabilitation has similar beneficial effects to surgical and pharmacological management without the potential negative side effects. Cycling-based interventions have been shown to increases motor function and mobility in individuals with PD. Specifically, benefits are greater when cycling cadence (revolutions per minute, RPM) is 30% greater than a self-selected pace.
Although high cadence cycling improves motor function in individuals with PD, there is significant heterogeneity in individual responses. To maximize the treatment effects and minimize the heterogeneity of high-cadence cycling, it is important to determine patient-specific settings. Previous studies have shown that higher variability (entropy) of cadence leads to greater improvement in motor function. The entropy of cadence calculation will be utilized to understand how patient-specific settings can drive improvements. The purpose of this study is to determine patient-specific settings and measure the effects of high cadence stationary (i.e. dynamic) cycling on functional performance in individuals with PD. Volunteers with Parkinson's disease will complete 12 cycling sessions over a 1-month period and measures of motor function, quality of life, functional performance, mood and exercise readiness will be collected.
Detailed description
Potential participants will be prescreened with the ACSM pre-participation questionnaire over the phone or in person. Those who qualify will be asked to visit the research lab and sign the informed consent. Participants will be randomized into one of two groups: 1) patients-specific adaptive dynamic cycling or 2) non-adaptive dynamic cycling. Both groups will participate in a total of 12 sessions, each session consisting of 5 minutes of warm-up, 30 minutes of the main exercise, and 5 minutes of the cool-down period. For the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session. For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled study with 2 arms
| Arm | Type | Receives |
|---|---|---|
| Adaptive dynamic cycling | Experimental | Behavioral: Dynamic high-cadence cyclingFor the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session. |
| Non-adaptive dynamic cycling | Active comparator | Behavioral: Dynamic high-cadence cyclingFor the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's disease
- 50-79 years of age
- no contraindications to exercise including cardiovascular disease or stroke
Key exclusion criteria (1 listed)
- one or more major signs/symptoms of cardiovascular or pulmonary disease
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 |
|---|---|---|
| Dynamic high-cadence cyclingAlso: S.M.A.R.T. cyclingResistance settings will be changed based on entropy of cadence every 3 sessions. Cadence will be set at 80RPM for both groups | Behavioural | Adaptive dynamic cycling, Non-adaptive dynamic cycling |
Primary outcome
Change in motor symptoms
Time frame: 4 weeks
MDS-UPDRS Motor III (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) Minimum Score-0 Maximum Score- 138 Lower score represents improvement
Change in motor kinematics
Time frame: 4 weeks
Kinesia One- Accelerometry- Lower score represents milder symptoms
2 secondary outcomes
Change in quality of life
Time frame: 4 weeks
Change in mobility
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Results publication: PubMed 31197095Harper SA, Dowdell BT, Kim JH, Pollock BS, Ridgel AL. Non-Motor Symptoms after One Week of High Cadence Cycling in Parkinson's Disease. Int J Environ Res Public Health. 2019 Jun 14;16(12):2104. doi: 10.3390/ijerph16122104.
- Results publication: PubMed 27298575Mohammadi-Abdar H, Ridgel AL, Discenzo FM, Loparo KA. Design and Development of a Smart Exercise Bike for Motor Rehabilitation in Individuals with Parkinson's Disease. IEEE ASME Trans Mechatron. 2016 Jun;21(3):1650-1658. doi: 10.1109/TMECH.2015.2508030. Epub 2015 Dec 11.
- Results publication: PubMed 30944720Ridgel AL, Ault DL. High-Cadence Cycling Promotes Sustained Improvement in Bradykinesia, Rigidity, and Mobility in Individuals with Mild-Moderate Parkinson's Disease. Parkinsons Dis. 2019 Mar 3;2019:4076862. doi: 10.1155/2019/4076862. eCollection 2019.
- Results publication: PubMed 27046905Mohammadi-Abdar H, Ridgel AL, Discenzo FM, Phillips RS, Walter BL, Loparo KA. Test and Validation of a Smart Exercise Bike for Motor Rehabilitation in Individuals With Parkinson's Disease. IEEE Trans Neural Syst Rehabil Eng. 2016 Nov;24(11):1254-1264. doi: 10.1109/TNSRE.2016.2549030. Epub 2016 Mar 31.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic high-cadence cycling in people with Parkinson Disease, run by Kent State University 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela L Ridgel, PhD (330-672-7495, aridgel@kent.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor symptoms (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT05361200, which also lists 4 linked publications.
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 16 Feb 2024.