Partnered Dance Aerobic Exercise as a Neuroprotective, Motor and Cognitive Intervention in Parkinson's Disease (PDAE in PD)

January 9, 2026 updated by: VA Office of Research and Development
Parkinson's disease (PD) is a difficult to treat condition that impairs mobility and thinking. It is not fully treated by drugs and surgery. Two priority issues for most people with PD are "OFF-time" and Cognitive impairment. Even under best medical management, 74% of people with PD experience "OFF-time," which is when medications are just not working right. OFF-time severely impacts both quality of life and thinking. Cognitive problems are found even in newly diagnosed people with PD and are very difficult to treat. However, the investigators' research has shown that partnered dance-aerobic exercise (PDAE) reduces OFF-time on the official test for OFF-time of the Movement Disorders Society, the Movement Disorders Society Unified Parkinson Disease Rating Scale-IV, (MDS-UPDRS-IV). PDAE improves other symptoms too. Benefits of the therapy have lasted for at least one-month after PDAE sessions stopped. PDAE provides aerobic exercise during an improvisational, cognitively-engaging physical activity. Cognitive engagement is a critical component of PDAE. Previous research showed PDAE improved spatial cognition, the ability to navigate, to mentally picture shapes and paths in the mind and to know the relationships between objects, people and places. Also, the investigators showed with imaging of the brain using a magnet in a scanner that twice weekly PDAE training increases activity in brain regions used in thinking and decision making. The investigators know that exercise benefits mobility and cognitive problems. The investigators even think exercise might protect brain cells in people with PD. But no one has really been able to show with biomarkers that exercise is protective of brain cells in humans.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will conduct a study in Veterans and non-Veterans with diagnosed PD to compare PDAE versus walking for OFF-time, cognition, and brain cell protection. The investigators will use a method like a coin flip to decide if the participants will be doing PDAE or walking. Importantly, the investigators will see if brain cells are protected using a brain scan that looks at the areas affected by PD to determine the relative amounts of different hormones in the brain that are related to having Parkinson's. The investigators will use these measurements of these hormones to chart the course of brain cell breakdown in patients with PD who have done walking or PDAE for 16 months. The investigators think that that PDAE will be better at lessening OFF-time and making cognition better than walking. The investigators think this because participants have to really use the mind during PDAE because the participants have so much to think about in terms of the steps and patterns. The investigators will assign 102 Veterans with mild-moderate PD to either 16 months of PDAE or walking. The investigators will use a coin toss or other similar method to determine who goes in what group. The investigators need participants to be in the classes for 16-months because it takes that long for us to see if anything changed in the brain with those hormones. Participants will do twice weekly classes for the first 3 months and then will switch down to taking lessons just 1 time per week for 13 months. The investigators will schedule appointments for participants to be seen by the research team before Veterans begin lessons, at 3 months (after the twice weekly schedule) and at 16 months after all the lessons are completed. The appointments will consist of asking the Veterans about their OFF-time having them take a few memory and thinking tests. The investigators will also ask them to lie in a scanner for about an hour. The participants can rest in the scanner for about a 1/2 hour and also do a thinking task. The investigators will be able to answer the questions, "Is PDAE better than walking at lessening OFF-time and spatial cognition and slowing down brain cell death? This study is using cutting edge imaging techniques for the first time to see if dance or walking are helpful for slowing brain cell death. This project combines patient-centered, clinical science and mechanistic aims to improve health care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Madeleine E Hackney, PhD
  • Phone Number: 5006 (404) 321-6111
  • Email: mehackn@emory.edu

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033-4004
        • Atlanta VA Medical and Rehab Center, Decatur, GA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: older than 40 years (40 is upper limit for young onset PD)
  • Montreal Cognitive Assessment (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 either group
  • H&Y stages I-III
  • Report OFF times (reporting >0 on item 4.3 of the UPDRS-IV)

  • Show clear symptomatic benefit from antiparkinsonian medications

    • e.g., alleviated rigidity, bradykinesia, and tremor
  • Fluent in English to comprehend and participate

Exclusion Criteria:

  • 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
  • Previous participation in PDAE or WAE classes.
  • Alcohol abuse and/or use of antipsychotics
  • Lives outside of the study site or is planning to move out of the area in next year or leave the area for >1 month during the next year
  • Taking moderate to high doses of beta-blockers with a resting heart rate below 60 beats/min since exercise intensity is measured through target heart rate.

  • Severe cardiac disease, including:

    • New York Heart Association (NYHA) Class III or IV congestive heart failure
    • clinically significant aortic stenosis
    • history of cardiac arrest, use of a cardiac defibrillator

    • uncontrolled angina

      • as discussed we are not planning to perform routine exercise tolerance tests prior to enrollment

  • 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)
  • Any contraindications to MRI eg claustrophobia, etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Partnered Dance Aerobic Exercise
Partnered Dance-Aerobic Exercise (PDAE) is an adapted form of Argentine tango, aka Adapted tango. Participants with PD will dance the follower role only and will dance with new partners (individuals without PD) every 15-20 minutes, a widely practiced method considered by the dance teaching community to enhance learning. Participants will engage in partnering exercises on how to interpret motor goals through touch, exercises to develop understanding of temporal relationship of movement to music, novel step introduction, connecting previously learned and novel step elements. Frequent repetition and musical stereotypes may foster implicit learning or muscle memory (i.e., motor learning, or procedural memory that involves consolidating a specific motor task into memory through repetition). Participants will not be required to memorize specific step patterns but will learn new steps in each class
Behavioral: PDAE
Participants with PD will dance the follower role only and will dance with new partners (individuals without PD) every 15-20 minutes, a widely practiced method considered by the dance teaching community to enhance learning. Participants will engage in partnering exercises on how to interpret motor goals through touch, exercises to develop understanding of temporal relationship of movement to music, novel step introduction, connecting previously learned and novel step elements. Frequent repetition and musical stereotypes may foster implicit learning or muscle memory (i.e., motor learning, or procedural memory that involves consolidating a specific motor task into memory through repetition). Participants will not be required to memorize specific step patterns but will learn new steps in each class
Active Comparator: Walking Aerobic Exercise
Walking Aerobic Exercise (WAE) Participants in WAE will receive equivalent dose, volume, frequency, intensity and duration of exercise to the PDAE group. The investigators will receive equal contact and monitoring from study staff. WAE participants will report to the same facility and interact with the same interventionist and assistants. The investigators will participate in sessions focused on at least 60 minutes of walking with breaks ad libitum, and 1/2 hour balance and stretching. The investigators have a designated, safe and non-cluttered area for walking. WAE will also take place in groups, with research volunteers and assistants to ensure that PDAE and WAE participants both receive a socially engaging intervention.
Behavioral: WAE
The participants will receive equal contact and monitoring from study staff. WAE participants will report to the same facility and interact with the same interventionist and assistants. The participants will participate in sessions focused on at least 60 minutes of walking with breaks ad libitum, and 1/2 hour balance and stretching. The investigators have a designated, safe and non-cluttered area for walking. WAE will also take place in groups, with research volunteers and assistants to ensure that PDAE and WAE participants both receive a socially engaging intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Movement disorders Society Unified Parkinson's Disease Rating Scale Part IV total score
Time Frame: 16 months
The primary outcome, the MDS-UPDRS-IV score measures medication related motor fluctuations, including dyskinesias, OFF-time, functional impact and complexity of fluctuations, and dystonia. The investigators will administer a monthly OFF-state diary for corroboration of these scores.
16 months
Corsi Blocks product score
Time Frame: 16 months
The product score is the product of the span and number of correct trials achieved by the participant. The Corsi Blocks is a test of spatial cognition, specifically visuospatial working memory.
16 months
rate of change in iron accumulation in the substantia nigra pars compacta
Time Frame: 16 months
The investigators will measure R2* in the NM-MRI defined SNc using a published image processing and analysis method. This method leverages a standard space SNc atlas developed using control population NM-MRI data, enabling R2* measurement in SNc with no operator-dependent segmentation steps
16 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6 minute walk test (number of meters walked in 6 minutes)
Time Frame: 16 months
The six minute walk test is a validated test of endurance in older adults and in those with Parkinson disease. Participants are asked to walk as far as they can in 6 minutes, while being monitored and able to carry on a conversation. The distance is measured in meters.
16 months
cardiovascular output: V02 maximum
Time Frame: 16 months
This sub-maximal test can estimate the participant's VO2max and initial fitness level. This test uses a method in which heart rate (HR) workload values are obtained at 2-4 points and extrapolated to predict workload at the estimated maximum HR (e.g. 220-age). VO2max is then calculated from the predicted maximum workload.
16 months
neural measure of spatial cognition (BOLD signal)
Time Frame: 16 months
At each study visit T1 MPRAGE, and T2* weighted blood oxygen level dependent (BOLD) fMRI data will be acquired at the Emory CSI, using a Siemens Prisma-Fit 3T MRI scanner with a 64 channel receive-only head coil in a protocol with total scan time one hour. BOLD signal will be measured in response to the functional task, the Block span task.
16 months
rate of change in loss of neuromelanin in substantia nigra pars compacta
Time Frame: 16 months
At each study visit NM-MRI, R2*, T1 MPRAGE, and T2* weighted blood oxygen level dependent (BOLD) fMRI data will be acquired. The investigators will carry out image processing to determine SNc volume using an automated approach previously shown to have high scan-rescan reproducibility.
16 months
Executive function: Tower Of London achievement score
Time Frame: 16 months
The Delis Kaplan tower of London test is a validated measure of executive function in PD.
16 months
Benton's judgment of line orientation task
Time Frame: 16 months
Judgment of Line Orientation is a standardized test of visuospatial skills commonly associated with functioning of the parietal lobe in the right hemisphere. The test measures a person's ability to match the angle and orientation of lines in space. Subjects are asked to match two angled lines to a set of 11 lines that are arranged in a semicircle and separated 18 degrees from each other.
16 months
gait- forward, fast as possible, backward speeds
Time Frame: 16 months
Objective, spatiotemporal parameters including velocity, stride length, stance percent, velocity variability and other variables of preferred, backward and fast-as-possible walking will be assessed.
16 months
attention: Trails Making Test A
Time Frame: 16 months
Trails making test A is a validated measure of attention and visuospatial processing in people with PD. The time to complete is considered.
16 months
spatial imagery: Brooks spatial memory task percent correct
Time Frame: 16 months
Brooks spatial memory involves reporting back a specified path of numbers that patients are asked to visualize in a 4 x 4 grid.
16 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mini BESTest score
Time Frame: 16 months
The Mini BESTest is a 14-item test scored on a 3-level ordinal scale. Mini BESTest assesses dynamic balance, a unidimensional construct. It is validated in PD.
16 months
Four Square Step Test (time to complete)
Time Frame: 16 months
The FSST is a valid measure of motor cognitive integration and involves the participant stepping as quickly and safely as they can in four quadrants created by four canes arranged in a cross, in a clockwise order and then switching to counterclockwise order.
16 months
Dynamic Gait index
Time Frame: 16 months
The DGI is a clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks.
16 months
Single/Dual Timed up and go (time to complete and dual task costs)
Time Frame: 16 months
Timed Up & Go Test (TUG) is a test of balance that is commonly used to examine functional mobility. The single condition requires participants to get up from a chair walk three meters, turn around and return to the chair as quickly and as safely as they can. The dual versions involve cognitive tasks (counting backward by 3s from given number) and manual, holding a full cup of water, while performing single tug.
16 months
Parkinson Disease Questionnaire -39
Time Frame: 16 months
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month Assesses how often patients experience difficulties across the 8 quality of life dimensions
16 months
composite physical function index
Time Frame: 16 months
This validate scale assesses the ability of people with impairments to complete various tasks of daily living ranging from holding a bag of groceries to walking a couple of blocks to being able to take a bath unassisted.
16 months
Movement disorders Society Unified Parkinson's disease rating scale parts I-III
Time Frame: 16 months
Part I assesses non motor aspects of experiences of daily living for people with PD. Part II assesses motor aspects of experiences of daily living for people with PD. Part III is a rated scale of motor function. The MDS UPDRS is validated and reliable and widely used globally.
16 months
Beck depression inventory score
Time Frame: 16 months
This widely used test of depression is validated in PD.
16 months
Freezing of Gait questionnaire total score
Time Frame: 16 months
The Freezing of Gait Questionnaire (FOG-Q) reliably detects FOG in patients with Parkinson's disease (PD).
16 months
Physical Scale for the Elderly score (PASE)
Time Frame: 16 months
PASE comprises measures of self-reported occupational, household, and leisure activities during a one-week period. Designed for use in epidemiologic studies and exercise interventions, the instrument can be administered by telephone, mail, or in person in 5 to 15 minutes.
16 months
Short Form 12
Time Frame: 16 months
A generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. Subscales of interest include the Mental composite and physical composite scores among others.
16 months
Satisfaction with Training period questionnaire
Time Frame: 3 months
Participants will complete the Exit Questionnaire which asks their level of agreement on a Likert scale (1-5) with 1 indicating the most agreement about whether they think they improved in various aspects of wellbeing.
3 months
Satisfaction with Maintenance period questionnaire
Time Frame: 16 months
Participants will complete the Exit Questionnaire which asks their level of agreement on a Likert scale (1-5) with 1 indicating the most agreement about whether they think they improved in various aspects of wellbeing.
16 months
Satisfaction with Life scale
Time Frame: 16 months
Valid for PD, this scale allows self report of level of satisfaction with life and life events in people with PD.
16 months
Multidimensional Scale of Perceived social support (MSPSS)
Time Frame: 16 months
The MSPSS aims to determine how social support factors are perceived by individuals, with three subscales to evaluate support by family, friends and significant others.
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Madeleine E. Hackney, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F2967-R
  • IRB112770 (Other Grant/Funding Number: United States Department of Affairs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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