Parkinsons DiseasePDEXNCT02676804
Exercise Dosing Trial for Individuals With Parkinson's Disease
A study testing High-intensity, aerobic exercise. in people with Parkinsons Disease, run by University of Virginia at 1 site in United States.
Trial summary
This is a prospective, pre-post intervention study to evaluate the effect of a high-intensity, aerobic exercise program on outcomes of cognition, mood, gait, balance, cardiorespiratory fitness, neuromuscular performance, fatigue, sleep, and quality of life for patients diagnosed with idiopathic Parkinson disease. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinsons Disease
- What is being tested?
- High-intensity, aerobic exercise.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with idiopathic Parkinson Disease as determined by United Kingdom Brain Bank Criteria. This includes the presence of bradykinesia with one or both of the following: rest tremor and/or rigidity
- Asymmetric onset of PD and progressive motor symptoms.
- Hoehn and Yahr stage 2 or 3.
- Stable dopaminergic medication regimen for 4 weeks prior to baseline visit with no anticipated changes for the duration of the study.
- Stable doses of medications known to affect sleep and medications for Parkinson's Disease for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
- Ability to complete exercise intervention and assessment visits during at least 16 weeks of intervention (3x/week for 16 weeks).
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- Must pass a physical examination to assess exercise readiness.
- Women of childbearing potential may enroll but must use a reliable measure of contraception and have a negative serum pregnancy test at the screening visit.
- Montreal Cognitive Assessment score ≥ 18 and ≤30.
- Ability to pass a Physical Activity Readiness Questionnaire to assess exercise readiness.
Who cannot join
- Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
- Neuroleptic treatment at time of onset of Parkinsonism
- Active treatment with a neuroleptic at time of study entry. Exceptions to this are quetiapine and clozapine.
- History of multiple strokes with stepwise progression of Parkinsonism
- History of multiple head injuries
- Inability to walk without assistance, including a cane, wheelchair, or walker
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- Regular participation in an exercise program within the past 6 months.
- Deep Brain Stimulation or other neurosurgical procedure for PD.
- Untreated sleep apnea
- Known narcolepsy
- Participation in drug studies or the use of investigational drugs within 30 days prior to screening
- Acute illness or active, confounding medical, neurological, or musculoskeletal conditions that, at the discretion of the PI, would prevent the subject's ability to participate in the study
- Known contraindication to testing
- Active alcoholism or other drug addiction
- Pregnancy
- Moderate to severe dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
This is a prospective, pre-post intervention study to evaluate the effect of a high-intensity, aerobic exercise program on outcomes of cognition, mood, gait, balance, cardiorespiratory fitness, neuromuscular performance, fatigue, sleep, and quality of life for patients diagnosed with idiopathic Parkinson disease. The primary outcomes will be a composite measure of cognitive function and the Timed Up and Go (TUG).
Read the detailed description
All subjects will be assigned to aerobic exercise that will use a blend of both unsupervised moderate and supervised high intensity exercise. The exercise will consist of walking / jogging modalities, dependent on the individual's level of bradykinesia and will be paced by the individual's level of perceived exertion. The exercise protocol will be designed to target an accumulation of at least 150 minutes of cardiovascular exercise per week.
Exercise training will be performed 5x/week for a total of 16 weeks. The training will consist of 3 supervised high intensity sessions and 2 at home moderate intensity exercise sessions. The high intensity sessions will be performed on a treadmill at an intensity rating of ~ 15 and 17 on a rating of perceived exertion (RPE) scale of 6 to 20. The moderate intensity exercise will target an RPE of ~10 - 12 and participants will be asked to complete this on their own.
- Conditions
- Parkinsons Disease
- Being tested
- High-intensity, aerobic exercise.
- Keywords
- Exercise
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity, aerobic exercise.Other
Aerobic exercise will blend unsupervised moderate and supervised high intensity exercise. It will consist of walking/jogging modalities, dependent on the subject's level of bradykinesia, paced by the subject's level of perceived exertion. The exercise protocol will be designed to target an total of at least 150 minutes of cardio exercise per week.
Exercise training will be performed 5 times per week for 6 weeks, consisting of 3 supervised high intensity sessions and 2 at home moderate intensity sessions. High intensity sessions will be performed on a treadmill at an intensity rating of ~ 15 and 17 on a rating of perceived exertion (RPE) scale of 6 to 20. The moderate intensity exercise will target an RPE of ~10 - 12 and participants will be asked to complete this on their own.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity aerobic exercise | Experimental | Subjects will participate in a 16 week high-intensity aerobic exercise program. Receives: Other: High-intensity, aerobic exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Composite Cognitive Score
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons DiseaseStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madaline Harrison, University of Virginia
- Investigators
- Harrison B Madaline, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676804
- Sponsor's protocol ID
- 18664
- Acronym
- PDEX
- Status last verified
- Nov 2022
- First submitted
- 1 Feb 2016
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: If data is shared, Investigators plan to obtain a material transfer agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Dosing Trial for Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02676804
- Acronym / sponsor ID
- PDEX / 18664
- Conditions
- Parkinsons Disease
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 8 Feb 2016 (estimated)
- 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.
This is a prospective, pre-post intervention study to evaluate the effect of a high-intensity, aerobic exercise program on outcomes of cognition, mood, gait, balance, cardiorespiratory fitness, neuromuscular performance, fatigue, sleep, and quality of life for patients diagnosed with idiopathic Parkinson disease. The primary outcomes will be a composite measure of cognitive function and the Timed Up and Go (TUG).
Detailed description
All subjects will be assigned to aerobic exercise that will use a blend of both unsupervised moderate and supervised high intensity exercise. The exercise will consist of walking / jogging modalities, dependent on the individual's level of bradykinesia and will be paced by the individual's level of perceived exertion. The exercise protocol will be designed to target an accumulation of at least 150 minutes of cardiovascular exercise per week.
Exercise training will be performed 5x/week for a total of 16 weeks. The training will consist of 3 supervised high intensity sessions and 2 at home moderate intensity exercise sessions. The high intensity sessions will be performed on a treadmill at an intensity rating of ~ 15 and 17 on a rating of perceived exertion (RPE) scale of 6 to 20. The moderate intensity exercise will target an RPE of ~10 - 12 and participants will be asked to complete this on their own.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-intensity aerobic exercise | Experimental | Other: High-intensity, aerobic exercise.Subjects will participate in a 16 week high-intensity aerobic exercise program. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with idiopathic Parkinson Disease as determined by United Kingdom Brain Bank Criteria. This includes the presence of bradykinesia with one or both of the following: rest tremor and/or rigidity
- Asymmetric onset of PD and progressive motor symptoms.
- Hoehn and Yahr stage 2 or 3.
- Stable dopaminergic medication regimen for 4 weeks prior to baseline visit with no anticipated changes for the duration of the study.
- Stable doses of medications known to affect sleep and medications for Parkinson's Disease for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
Key exclusion criteria (16 listed)
- Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
- Neuroleptic treatment at time of onset of Parkinsonism
- Active treatment with a neuroleptic at time of study entry. Exceptions to this are quetiapine and clozapine.
- History of multiple strokes with stepwise progression of Parkinsonism
- History of multiple head injuries
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 |
|---|---|---|
| High-intensity, aerobic exercise.Aerobic exercise will blend unsupervised moderate and supervised high intensity exercise. It will consist of walking/jogging modalities, dependent on the subject's level of bradykinesia, paced by the subject's level of perceived exertion. The exercise protocol will be designed to target an total of at least 150 minutes of cardio exercise per week. Exercise training will be performed 5 times per week for 6 weeks, consisting of 3 supervised high intensity sessions and 2 at home moderate intensity sessions. High intensity sessions will be performed on a treadmill at an intensity rating of ~ 15 and 17 on a rating of perceived exertion (RPE) scale of 6 to 20. The moderate intensity exercise will target an RPE of ~10 - 12 and participants will be asked to complete this on their own. | Other | High-intensity aerobic exercise |
Primary outcome
Global Composite Cognitive Score
Time frame: 16 weeks
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 4 Nov 2022.
- Individual participant dataSharing planned: Undecided. If data is shared, Investigators plan to obtain a material transfer agreement.
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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.
Harrison B Madaline, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity, aerobic exercise. in people with Parkinsons Disease, run by University of Virginia 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 10 inclusion and 16 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 4 Nov 2022. 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?
Global Composite Cognitive Score (time frame: 16 weeks). 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 4 Nov 2022.