Exercise Dosing Trial for Individuals With Parkinson's Disease
Status: | Active, not recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 45 - Any |
Updated: | 2/6/2019 |
Start Date: | March 2016 |
End Date: | March 2019 |
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).
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).
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.
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.
Inclusion Criteria:
- Subjects with idiopathic PD 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).
- 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.
Exclusion Criteria:
- 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
- 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
We found this trial at
1
site
1215 Lee St
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Matthew J Barrett, MD
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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