Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months. 370 persons diagnosed with Parkinson's disease who have not yet initiated dopaminergic therapy, age 40-80, will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. Secondary objectives will test hypotheses related to striatal specific binding ratio (SSBR) at 12 months, MDS-UPDRS Part III score, ambulatory mobility (6-minute walk), daily walking activity (steps), cognition, quality of life, cardiorespiratory fitness, blood-derived biomarkers of inflammation and neurotrophic factors at 12 and 18 months. Exploratory objectives will test hypotheses related to the effects of removing the study support that was provided over 18 months on the sustainability and durability of the exercise effects at 24 months. Approximately 29 sites will enroll participants: 27 sites that cover all geographic regions of the USA and 2 sites in Canada. All sites will have a collaboration between movement disorders and exercise specialist.

Keywords

Parkinson Disease Treadmill walking High Intensity Exercise Moderate Intensity Exercise

Eligibility

You can join if…

Open to people ages 40-80

  • 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 CAN'T join 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 30 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)
  • 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 (creatinine clearance calculated by the Cockcroft-Gault equation <50mL/min, or estimated glomerular filtration rate 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, 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 <26 to rule out mild cognitive impairment (MCI).
  • Beck Depression Inventory II (BDI) score > 16, indicating depression that precludes ability to exercise. Any subject with such a score will be referred to a primary care physician (PCP) or physician for further evaluation and management of depression.
  • "Vigorous athletes" participating in any endurance exercise program 3x/week or more will be excluded. Vigorous is defined as endurance exercise in a range greater than 60-65% HRmax. These individuals are excluded since their exercise activities are similar to the activities they would experience if they were assigned to the 60-65% treatment group.
  • Use of the following within 90 days prior to the dopamine transporter (DAT) neuroimaging screening evaluation: bupropion, modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, any amphetamine or amphetamine derivative. 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.
  • Prior SPECT scan within 6 months of baseline scan. Recruitment will be delayed for individuals who have had a previous SPECT scan within 6 months of the baseline scan.
  • (For women only) 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).

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • University of Southern California
    Los Angeles California 90007 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Northwestern University
ID
NCT04284436
Study Type
Interventional
Last Updated