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Parkinson's DiseasePDAE in PDNCT04122690

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

A study testing PDAE and WAE in people with Parkinson's Disease and Exercise Therapy, run by VA Office of Research and Development at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 89 years
Conditions the study is for
Parkinson's Disease, Exercise Therapy, Cognition
What is being tested?
PDAE and WAE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
25 Jan 2021to 15 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004

Other trials in United States

About this study

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.

Read the 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.

Being tested
PDAE, WAE
Keywords
motor control, Parkinson disease, exercise, neural imaging, dance, spatial cognition, executive function, substantia nigra, neurodegeneration, rehabilitation
Medical subject headings
Parkinson Disease, Motor Activity, Nerve Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PDAEBehavioural

    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

  • WAEBehavioural

    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

Study groups in NCT04122690
Study groupRoleWhat they receive
Partnered Dance Aerobic ExerciseExperimentalPartnered 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
Receives: Behavioral: PDAE
Walking Aerobic ExerciseActive comparatorWalking 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.
Receives: Behavioral: WAE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement disorders Society Unified Parkinson's Disease Rating Scale Part IV total score

    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.

    Measured: 16 months

  2. Corsi Blocks product score

    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.

    Measured: 16 months

  3. rate of change in iron accumulation in the substantia nigra pars compacta

    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

    Measured: 16 months

Secondary outcomes (9)
  1. 6 minute walk test (number of meters walked in 6 minutes)

    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.

    Measured: 16 months

  2. cardiovascular output: V02 maximum

    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.

    Measured: 16 months

  3. neural measure of spatial cognition (BOLD signal)

    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.

    Measured: 16 months

  4. rate of change in loss of neuromelanin in substantia nigra pars compacta

    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.

    Measured: 16 months

  5. Executive function: Tower Of London achievement score

    The Delis Kaplan tower of London test is a validated measure of executive function in PD.

    Measured: 16 months

  6. Benton's judgment of line orientation task

    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.

    Measured: 16 months

  7. gait- forward, fast as possible, backward speeds

    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.

    Measured: 16 months

  8. attention: Trails Making Test A

    Trails making test A is a validated measure of attention and visuospatial processing in people with PD. The time to complete is considered.

    Measured: 16 months

  9. spatial imagery: Brooks spatial memory task percent correct

    Brooks spatial memory involves reporting back a specified path of numbers that patients are asked to visualize in a 4 x 4 grid.

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start25 Jan 2021
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
PDAE compared with WAE
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04122690
Sponsor's protocol ID
F2967-R
Other IDs
IRB112770
Acronym
PDAE in PD
Status last verified
Jan 2026
First submitted
9 Oct 2019
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim H, Rafie F, Nekouei AH, Kazanski ME, Hackney ME. Compliance and Satisfaction for 16 months of Adapted Tango vs. Supervised Walking for People with Parkinson's. NPJ Parkinsons Dis. 2025 Dec 26;12(1):13. doi: 10.1038/s41531-025-01220-8.

    PubMed 41453883
  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PubMed 38588457
  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PubMed 36602886

Questions about this trial

What is this clinical trial studying?

A study testing PDAE and WAE in people with Parkinson's Disease and Exercise Therapy, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement disorders Society Unified Parkinson's Disease Rating Scale Part IV total score (time frame: 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04122690, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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