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

NCT06088355 | Recruiting

• 1 other identifier: E4817-R
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Movement Disorders; Neurodegeneration; Parkinson Disease

Keywords

dance; walk; Neurodegenerative; aging; exercise; high volume; frequency; intensity; duration; biomarkers; Parkinson's disease

Outcome Measures

Primary Outcomes (3)

• Gait cadence

  Gait Cadence is the number of human steps taken per minute while walking.

  52 weeks

• Physical activity scale for the elderly (PASE)

  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

• vascular function: Pulse wave velocity and Aortic index

  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

Secondary Outcomes (5)

• inflammatory cytokine expression: Brain derived neurotrophic factor and c-reactive protein

  52 weeks

• VO2 max- maximum oxygen consumption

  52 weeks

• inflammatory cytokine expression: and c reactive protein

  52 weeks

• Six minute walk test

  52 weeks

• gait speed (m/s)

  52 weeks

Study Arms (3)

HV-PDAE: High Volume Partnered Dance Aerobic Exercise

EXPERIMENTAL

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.

Behavioral: HV-PDAE: High Volume Partnered Dance Aerobic Exercise

MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise

ACTIVE COMPARATOR

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.

Behavioral: MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise

MV-WALK: Moderate Volume Walking

ACTIVE COMPARATOR

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.

Behavioral: MV-WALK: Moderate Volume Walking

Interventions

MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise BEHAVIORAL

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: Moderate Volume Partnered Dance Aerobic Exercise

HV-PDAE: High Volume Partnered Dance Aerobic Exercise BEHAVIORAL

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: High Volume Partnered Dance Aerobic Exercise

MV-WALK: Moderate Volume Walking BEHAVIORAL

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

MV-WALK: Moderate Volume Walking

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Nerve Degeneration; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Madeleine E. Hackney, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine E Hackney, PhD

CONTACT

(404) 321-6111; mehackn@emory.edu

Joe R Nocera, PhD

CONTACT

(404) 321-6111; joenocera@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will not be aware if their treatment is experimental or control. With behavioral interventions, it is however, challenging to mask what the actual treatment is.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This RCT assigns n=102 (34 per group) older Veterans with PD to 52 weeks of PDAE at HV or moderate volume (MV) or to MV control (MV-WALK). Overall exercise dose will be 112.5 hours over 52 weeks. MV-PDAE and MV-WALK classes will meet twice-weekly for 65-minutes. HV PDAE classes will meet 5 times a week for 90 minutes for three weeks at trial onset followed by one HV week every 4 weeks for a year.

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 18, 2023
• Study Start: January 25, 2025
• Primary Completion (Estimated): January 29, 2028
• Study Completion (Estimated): June 2, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)