Exercise for Parkinson's Disease (HI-LITE Trial)
Palo Alto (17 mi)Overseen byMadeleine E. Hackney, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: VA Office of Research and Development
No Placebo Group
Trial Summary
What is the purpose of this trial?Veterans with mid to later stage Parkinson's disease (PD) may not be able to work out as hard as they need to, to prevent brain cell loss. Maybe they could work out longer and more frequently to make up for this during their good times and good weeks and then rest during the bad weeks. The investigators will compare how effective working out a lot one week per month with a break of three weeks is to continuously exercising weekly with no breaks in people with mid stage PD. The investigators will look at how fast participants walk per minute, whether they become more physically active, the biochemicals in their blood, and at how stiff their blood vessels are before and after the exercise.
Eligibility Criteria
This trial is for veterans over 40 with moderate Parkinson's disease (stages 2 to 3), who can walk at least 10 feet and have a certain level of cognitive function. They must not have severe depression, major psychiatric illness, significant hearing loss, or serious heart conditions. Participants should benefit from Parkinson's medication and be able to commit to the study duration without long absences.Inclusion Criteria
I can walk at least 10 feet by myself or with help.
I have Parkinson's with 3 key symptoms and respond well to medication.
My Parkinson's disease is at a moderate stage.
My cognitive test score is above 17.
I have been diagnosed with Parkinson's disease by a specialist.
I am over 40 and have been diagnosed with Parkinson's disease by a specialist.
I am fluent in English and can understand and participate fully.
Exclusion Criteria
I have not been treated for major depression or serious mental illness.
I have had a stroke or traumatic brain injury in the past.
I am on a moderate to high dose of beta-blockers and my resting heart rate is below 60.
I do not have severe heart problems like heart failure, aortic stenosis, or uncontrolled chest pain.
I do not abuse alcohol or use antipsychotics.
I do not have major health issues like kidney failure or drink heavily.
Treatment Details
The study compares two exercise regimens for those with mid-stage Parkinson's: one involves high volume dance aerobic exercise once a month followed by three weeks rest; the other is moderate exercise done consistently every week. The effects on walking speed, physical activity levels, blood biochemistry, and blood vessel stiffness will be measured.
3Treatment groups
Experimental Treatment
Active Control
Group I: HV-PDAE: High Volume Partnered Dance Aerobic ExerciseExperimental Treatment1 Intervention
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.
Group II: MV-PDAE: Moderate Volume Partnered Dance Aerobic ExerciseActive Control1 Intervention
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.
Group III: MV-WALK: Moderate Volume WalkingActive Control1 Intervention
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Atlanta VA Medical and Rehab Center, Decatur, GADecatur, GA
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor