- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06088355
Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease (HI-LITE)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joe R Nocera, PhD
- Phone Number: 6354 (404) 321-6111
- Email: joenocera@emory.edu
Study Contact Backup
- Name: Madeleine E Hackney, PhD
- Phone Number: 5006 (404) 321-6111
- Email: mehackn@emory.edu
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30033-4004
- Atlanta VA Medical and Rehab Center, Decatur, GA
-
Contact:
- Lisa Calas
- Phone Number: 206795 404-321-6111
- Email: lisa.calas@va.gov
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Contact:
- Erica W Watkins, BA
- Phone Number: 5830 (404) 321-6111
- Email: erica.watkins@va.gov
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Principal Investigator:
- Madeleine E. Hackney, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants recruited for this study will be age 40 and older with diagnosis of "definite" PD based upon established criteria (Hughes, Daniel et al. 1992) and determined by a board-certified neurologist with specialty training in movement disorders. Individuals must have presented with asymmetric symptoms that included at least 3 of the cardinal signs of PD (rigidity, bradykinesia, tremor, postural instability), and must show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications, e.g., levodopa (Kempster, Williams et al. 2007). They should be in H&Y stages 2, 2.5 and 3, and receive a Montreal Cognitive Assessment (MoCA) score >17 (Litvan, Goldman et al. 2012). Age 40 is the upper limit for young onset PD. We will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. We will observe patients while OFF their antiparkinsonian medications to avoid dyskinesia, and medication fluctuations that may impact neurophysiology and motor examination. We have successfully observed patients while OFF in several previous trials. The following inclusion criteria apply:
- MoCA score >17
- Able to walk with or without an assistive device at least 10 feet
- Best corrected/aided acuity better than 20/70 in the better eye
- Willingness to be randomized to a treatment group
- H&Y stages 2, 2.5 and 3
- Show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications
- Fluent in English to be able to comprehend and participate; older than 40 years; Diagnosis of definite Parkinson's disease by board certified Movement Disorders Neurologist, using standardized UK Brain Bank criteria
Exclusion Criteria:
Participants recruited for this study will be age 40 and older with diagnosis of "definite" PD based upon established criteria (Hughes, Daniel et al. 1992) and determined by a board-certified neurologist with specialty training in movement disorders. Individuals must have presented with asymmetric symptoms that included at least 3 of the cardinal signs of PD (rigidity, bradykinesia, tremor, postural instability), and must show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications, e.g., levodopa (Kempster, Williams et al. 2007). They should be in H&Y stages 2, 2.5 and 3, and receive a Montreal Cognitive Assessment (MoCA) score >17 (Litvan, Goldman et al. 2012). Age 40 is the upper limit for young onset PD. We will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. The following exclusion criteria apply:
- Untreated Major Depression and major psychiatric illness
- History of stroke, or traumatic brain injury
- Pure-tone threshold average sensitivity at 0.5, 1.0,and 2.0 kHz exceeds 40 dB
- Alcohol abuse and/or use of antipsychotics
- Planning to leave the area for >1 month during the study time period.
- Taking moderate to high doses of beta-blockers with a resting heart rate below 60 beats/min given that exercise intensity is measured through target heart rate.
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, excessive alcohol use (>14 drinks per wk)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HV-PDAE: High Volume Partnered Dance Aerobic Exercise
HV-PDAE classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year.
All participants will receive 112.5h of training.
PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango.
People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student.
The instructor, staff lead and assistants monitor participants for safety.
Class sizes will consist of 6 or fewer pairs of participants with PD and partners.
Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes.
Participants will learn new steps in each class.
The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down.
PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
|
HV-PDAE classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year.
All participants will receive 112.5h of training.
PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango.
People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student.
The instructor, staff lead and assistants monitor participants for safety.
Class sizes will consist of 6 or fewer pairs of participants with PD and partners.
Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes.
Participants will learn new steps in each class.
The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down.
PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
|
Active Comparator: MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise
MV-PDAE: MV classes will meet biweekly for 52 weeks for 65-minute sessions.
All participants will receive 112.5h of training. .
PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango.
People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student.
The instructor, staff lead and assistants monitor participants for safety.
Class sizes will consist of 6 or fewer pairs of participants with PD and partners.
Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes.
Participants will learn new steps in each class.
The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down.
PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
|
MV-PDAE: MV classes will meet biweekly for 52 weeks for 65-minute sessions.
All participants will receive 112.5h of training. .
PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango.
People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student.
The instructor, staff lead and assistants monitor participants for safety.
Class sizes will consist of 6 or fewer pairs of participants with PD and partners.
Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes.
Participants will learn new steps in each class.
The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down.
PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
|
Active Comparator: MV-WALK: Moderate Volume Walking
MV-WALK (65-minute sessions): WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention.
Walking for exercise expends 3 METS, like PDAE.
(Knaggs et al., 2011) 65 minute sessions will consist of 15 minutes of warmup exercises, 45 minutes of walking with breaks ad libitum, and a 5-minute cool down.
Setting will be a designated, safe, non-cluttered area for walking- indoors or outdoors.
This protocol is in line with recommendations for gait training to improve gait parameters, i.e., 2-3 days per week, for 30-60 minutes and with evidence that light-moderate intensity walking programs can lead to gains in gait parameters.
|
MV-WALK (65-minute sessions): WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention.
Walking for
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vascular function: Pulse wave velocity and Aortic index
Time Frame: 52 weeks
|
Pulse wave velocity and augmentation aortic index are valid and reliable measures of vascular function.
Pulse-wave velocity (PWV) is a measurement of arterial stiffness and is an independent predictor of cardiovascular risk.
It can be assessed simply and noninvasively by measuring the carotid and femoral pulse pressures and the time delay between the two or by other methods relying on pulse-wave analysis.
|
52 weeks
|
Gait cadence
Time Frame: 52 weeks
|
Gait Cadence is the number of human steps taken per minute while walking.
|
52 weeks
|
Physical activity scale for the elderly (PASE)
Time Frame: 52 weeks
|
This questionnaire is very comprehensive and assesses an older adults' activity level within the previous week by totaling their involvement in a variety of physical activities.
The minimum score is 0 and the maximum score is 400.
Higher scores indicate better outcomes.
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inflammatory cytokine expression: Brain derived neurotrophic factor and c-reactive protein
Time Frame: 52 weeks
|
BDNF: This neurotrophic factor plays an important role in neuronal survival and growth, serves as a neurotransmitter modulator, and participates in neuronal plasticity, which is essential for learning and memory. Other studies have shown it increased in expression after structured long term exercise in populations with neurodegenerative disease. CRP: C reactive protein is a protein made by the liver. The level of CRP increases with inflammation in the body. Some studies have shown decreased levels of CRP in patients who underwent exercise. |
52 weeks
|
inflammatory cytokine expression: and c reactive protein
Time Frame: 52 weeks
|
These are both blood biomarkers derived from serum. Inflammatory cytokine expression: An inflammatory cytokine is a type of cytokine (a signaling molecule) that is secreted from immune cells and certain other cell types that promotes inflammation. Inflammatory cytokines are predominantly produced by T helper cells (Th) and macrophages and involved in the upregulation of inflammatory reactions. CRP: C reactive protein is a protein made by the liver. The level of CRP increases with inflammation in the body. Some studies have shown decreased levels of CRP in patients who underwent exercise. |
52 weeks
|
VO2 max- maximum oxygen consumption
Time Frame: 52 weeks
|
Vo2 max is the maximal amount of oxygen that someone can use during intense or maximal exercise.
It is a good indicator of cardiovascular fitness and aerobic endurance.
|
52 weeks
|
Six minute walk test
Time Frame: 52 weeks
|
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
|
52 weeks
|
gait speed (m/s)
Time Frame: 52 weeks
|
Preferred and fast as possible gait speed will be measured with motion capture (APDM opals) over a 20 foot path.
The speed is reported in meters per second.
|
52 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Madeleine E. Hackney, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E4817-R (Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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