RECRUITING

Study in Parkinson Disease of Exercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3

Quick Facts

Study Start:2021-08-30

Study Completion:2028-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04284436

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.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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. * Individuals who have been exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months will be excluded. Greater than moderate intensity is defined as a range greater than 60-65% HRmax. These individuals are excluded since their exercise activities are greater than the activities they would experience if they were assigned to the 60-65% treatment group. As such, they would be expected to lose fitness. * Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, any amphetamine or amphetamine derivative, or use of buproprion within 8 days prior to the DAT neuroimaging screening evaluation. These can compromise DaTscan™ SPECT. * Known allergy to iodinated products. * Known hypersensitivity to DaTscan™ SPECT (either to the active substance of 123I-ioflupane or any of the excipients. * (For women only) Actively breast-feeding an infant, and/or pregnant, or plan to become pregnant in the next 12 months. * Other disorders, injuries, diseases, or conditions that might interfere with ability to perform endurance exercises (e.g. history of stroke, respiratory problems, traumatic brain injury, orthopedic injury, or neuromuscular disease).

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.
* Individuals who have been exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months will be excluded. Greater than moderate intensity is defined as a range greater than 60-65% HRmax. These individuals are excluded since their exercise activities are greater than the activities they would experience if they were assigned to the 60-65% treatment group. As such, they would be expected to lose fitness.
* Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, any amphetamine or amphetamine derivative, or use of buproprion within 8 days prior to the DAT neuroimaging screening evaluation. These can compromise DaTscan™ SPECT.
* Known allergy to iodinated products.
* Known hypersensitivity to DaTscan™ SPECT (either to the active substance of 123I-ioflupane or any of the excipients.
* (For women only) Actively breast-feeding an infant, and/or pregnant, or plan to become pregnant in the next 12 months.
* Other disorders, injuries, diseases, or conditions that might interfere with ability to perform endurance exercises (e.g. history of stroke, respiratory problems, traumatic brain injury, orthopedic injury, or neuromuscular disease).

Contacts and Locations

Study Contact

Elizabeth Joslin

CONTACT

309-922-7254

elizabeth.joslin@northwestern.edu

Principal Investigator

Daniel M Corcos, PhD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

University of California, San Francisco

San Francisco, California, 94143

United States

University of Colorado, Denver

Aurora, Colorado, 80204

United States

University of Florida

Gainesville, Florida, 32611

United States

Morehouse School of Medicine

Atlanta, Georgia, 30310

United States

Emory University

Atlanta, Georgia, 30322

United States

Northwestern University

Chicago, Illinois, 60611

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Iowa State University

Ames, Iowa, 50011

United States

Louisiana State University

Baton Rouge, Louisiana, 70803

United States

Boston University (Charles River Campus)

Boston, Massachusetts, 02215

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Washington University St. Louis

Saint Louis, Missouri, 63130

United States

Columbia University Medical Center

New York, New York, 10032

United States

University of Cincinnati

Cincinnati, Ohio, 45221

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Ohio Health

Columbus, Ohio, 43214

United States

Kent State University

Kent, Ohio, 44240

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219

United States

UT Health San Antonio

San Antonio, Texas, 78229

United States

University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Northwestern University

Daniel M Corcos, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

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 Registration Dates

Study Start Date2021-08-30

Study Completion Date2028-07-31

Study Record Updates

Study Start Date2021-08-30

Study Completion Date2028-07-31

Terms related to this study

Additional Relevant MeSH Terms

Parkinson Disease