NCT04122690

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jan 2021Dec 2026

First Submitted

Initial submission to the registry

October 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5.9 years

First QC Date

October 9, 2019

Last Update Submit

January 9, 2026

Conditions

Keywords

motor controlParkinson diseaseexerciseneural imagingdancespatial cognitionexecutive functionsubstantia nigraneurodegenerationrehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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.

    16 months

  • 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.

    16 months

  • 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

    16 months

Secondary Outcomes (9)

  • 6 minute walk test (number of meters walked in 6 minutes)

    16 months

  • cardiovascular output: V02 maximum

    16 months

  • neural measure of spatial cognition (BOLD signal)

    16 months

  • rate of change in loss of neuromelanin in substantia nigra pars compacta

    16 months

  • Executive function: Tower Of London achievement score

    16 months

  • +4 more secondary outcomes

Other Outcomes (15)

  • Mini BESTest score

    16 months

  • Four Square Step Test (time to complete)

    16 months

  • Dynamic Gait index

    16 months

  • +12 more other outcomes

Study Arms (2)

Partnered Dance Aerobic Exercise

EXPERIMENTAL

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

Walking Aerobic Exercise

ACTIVE COMPARATOR

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

Interventions

PDAEBEHAVIORAL

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

Partnered Dance Aerobic Exercise
WAEBEHAVIORAL

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

Walking Aerobic Exercise

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Parkinson DiseaseMotor ActivityNerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Madeleine E. Hackney, PhD

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: PDAE compared with WAE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 10, 2019

Study Start

January 25, 2021

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations