NCT04284436

Brief Summary

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
27mo left

Started Aug 2021

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
2 countries

25 active sites

Status
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 Progress68%
Aug 2021Jul 2028

First Submitted

Initial submission to the registry

February 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.9 years

First QC Date

February 20, 2020

Last Update Submit

April 6, 2026

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Change in motor symptoms of Parkinson disease

    Change from baseline in the Movement Disorders Society-Unified Parkinson Disease Rating Scale motor score (Part III). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms.

    12 months

Secondary Outcomes (17)

  • Change in dopaminergic activity

    12 months

  • Change in motor symptoms of Parkinson disease

    18 months

  • Change in walking capacity

    12 months

  • Change in walking capacity

    18 months

  • Change in activity

    12 months

  • +12 more secondary outcomes

Other Outcomes (4)

  • Change in stride length

    12 months

  • Change in stride length

    18 months

  • Change in turning velocity

    12 months

  • +1 more other outcomes

Study Arms (2)

High Intensity Exercise

EXPERIMENTAL

Treadmill exercise 4x per week at 80-85% HRmax.

Behavioral: Treadmill walking

Moderate Intensity Exercise

ACTIVE COMPARATOR

Treadmill exercise 4x per week at 60-65% HRmax.

Behavioral: Treadmill walking

Interventions

Treadmill walkingBEHAVIORAL

Treadmill walking 4 days per week for 30 minutes in the target heart rate

High Intensity ExerciseModerate Intensity Exercise

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of idiopathic Parkinson Disease based on the modified \* United Kingdom (UK) PD brain bank criteria and which are consistent with recent criteria proposed for clinically established early established Parkinson's disease that no longer exclude individuals with a family history of Parkinson's disease.
  • Hoehn and Yahr stages less than 3
  • Disease duration: less than 3 years since disease diagnosis
  • Age 40-80 years
  • Positive DaTscan™ SPECT by quantitative readout for idiopathic Parkinson disease.

You may not qualify if:

  • Currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics.
  • Expected to require treatment with medication for PD in the first 6 months of the study.
  • Use of any PD medication 60 days prior to the baseline visit including but not limited to levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
  • Duration of previous use of medications for PD exceeds 60 days.
  • Use of neuroleptics/dopamine receptor blockers for more than 30 days in the year prior to baseline visit, or any use within 30 days of baseline visit
  • Presence of known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program.
  • Uncontrolled hypertension (resting blood pressure \>150/90 mmHg)
  • Individuals with orthostatic hypotension and standing systolic BP below 100 will be excluded. Orthostatic hypotension (OH) is a reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of standing.
  • Hypo- or hyperthyroidism (TSH \<0.5 or \>5.0 mU/L), abnormal liver function (AST or ALT more than 2 times the upper limit of normal), abnormal renal function (estimated glomerular filtration rate (eGFR) using the MDRD4 equation or the CKD-EPI equation \<45mL/min/1.73m2 ).
  • Complete Blood Count (CBC) out of range and physician's judgment that abnormal value is clinically significant.
  • Recent use of psychotropic medications (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants) where dosage has not been stable for 28 days prior to screening.
  • Serious illness (requiring systemic treatment and/or hospitalization) within the last 4 weeks.
  • Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse, assessment or laboratory abnormality that would, in the judgment of the investigator, interfere with the subject's ability to participate in the study.
  • Montreal Cognitive Assessment (MoCA) score of \<24.
  • Beck Depression Inventory II (BDI) score \> 28, indicating severe depression that precludes ability to exercise. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression. Individuals with a BDI-II score of 17-28 will be excluded if any of the following conditions are met: (1) individual is suicidal, (2) is in need of depression treatment modification currently or (3) depressive symptoms likely to interfere with adherence to study protocol. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Colorado, Denver

Aurora, Colorado, 80204, United States

RECRUITING

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

ACTIVE NOT RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Iowa State University

Ames, Iowa, 50011, United States

RECRUITING

Louisiana State University

Baton Rouge, Louisiana, 70803, United States

RECRUITING

Boston University (Charles River Campus)

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45221, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio Health

Columbus, Ohio, 43214, United States

RECRUITING

Kent State University

Kent, Ohio, 44240, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

UT Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Alberta

Edmonton, Canada

RECRUITING

Related Publications (3)

  • Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.

    PMID: 29228079BACKGROUND

  • Moore CG, Schenkman M, Kohrt WM, Delitto A, Hall DA, Corcos D. Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Contemp Clin Trials. 2013 Sep;36(1):90-8. doi: 10.1016/j.cct.2013.06.002. Epub 2013 Jun 14.

    PMID: 23770108BACKGROUND

  • Patterson CG, Joslin E, Gil AB, Spigle W, Nemet T, Chahine L, Christiansen CL, Melanson E, Kohrt WM, Mancini M, Josbeno D, Balfany K, Griffith G, Dunlap MK, Lamotte G, Suttman E, Larson D, Branson C, McKee KE, Goelz L, Poon C, Tilley B, Kang UJ, Tansey MG, Luthra N, Tanner CM, Haus JM, Fantuzzi G, McFarland NR, Gonzalez-Latapi P, Foroud T, Motl R, Schwarzschild MA, Simuni T, Marek K, Naito A, Lungu C, Corcos DM; SPARX3-PSG Investigators. Study in Parkinson's disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial. Trials. 2022 Oct 6;23(1):855. doi: 10.1186/s13063-022-06703-0.

    PMID: 36203214DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Daniel M Corcos, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Joslin

CONTACT

309-922-7254elizabeth.joslin@northwestern.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physical Therapy and Human Movement Sciences

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 25, 2020

Study Start

August 30, 2021

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All study data (deidentified) and documentation will be shared with the National Institute of Neurological Disease and Stroke.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
18 months after the study end.
Access Criteria
Once the data are in the NINDS data repository, NINDS will be responsible for determining with whom the data are shared. No data will be shared directly from the study data coordinating center.

Locations

US(24)CA(1)