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Behavioural Intervention

Exercise for Parkinson's Disease (HI-LITE Trial)

N/A

Waitlist Available

Led By Madeleine E. Hackney, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to walk at least 10 feet with or without an assistive device

Must have presented with asymmetric symptoms including at least 3 of the cardinal signs of Parkinson's disease (rigidity, bradykinesia, tremor, postural instability) and show clear symptomatic benefit from antiparkinsonian medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

HI-LITE Trial Summary

This trial looks at if exercising more on good weeks & resting on bad weeks can improve the health of veterans with mid stage PD.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed for this type of physical intervention, participants may experience fatigue, muscle soreness or strain due to increased physical activity especially if they are unaccustomed to regular exercise.

HI-LITE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk at least 10 feet by myself or with help.

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I have Parkinson's with 3 key symptoms and respond well to medication.

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My Parkinson's disease is at a moderate stage.

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My cognitive test score is above 17.

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I have been diagnosed with Parkinson's disease by a specialist.

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I am over 40 and have been diagnosed with Parkinson's disease by a specialist.

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I am fluent in English and can understand and participate fully.

HI-LITE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gait cadence

Physical activity scale for the elderly (PASE)

vascular function: Pulse wave velocity and Aortic index

Secondary outcome measures

Six minute walk test

VO2 max- maximum oxygen consumption

gait speed (m/s)

+2 more

HI-LITE Trial Design

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.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,061 Total Patients Enrolled

1 Trials studying Movement Disorders

10 Patients Enrolled for Movement Disorders

Madeleine E. Hackney, PhDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA

2 Previous Clinical Trials

261 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this clinical trial for individuals to enroll?

"Clinicaltrials.gov currently lists this trial as inactive; it was first announced on the 1st June 2024 and most recently edited on 12th October 2023. Though not presently recruiting, there are 570 other studies actively searching for test subjects."

Answered by AI

Is HV-PDAE: High Volume Partnered Dance Aerobic Exercise a secure activity for participants?

"There is some data indicating the safety of HV-PDAE: High Volume Partnered Dance Aerobic Exercise, warranting it a score of 2. However, clinical evidence substantiating its efficacy does not exist yet."

Answered by AI

What primary goals does this clinical trial aim to accomplish?

"The primary outcome assessed in this study, evaluated over a period of 52 weeks, will be physical activity measured by the Physical Activity Scale for the Elderly (PASE). Secondary outcomes include maximal oxygen consumption (VO2 max), inflammatory cytokine expression and C-reactive protein levels as blood biomarkers derived from serum, and the Six Minute Walk Test with accompanying gait speed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease

2024. "Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088355.

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