Table 1 Inclusion and exclusion criteria for Study in Parkinson Disease of Exercise (SPARX3) Trial
Inclusion criteria | |
1. A diagnosis of idiopathic PD based on the modified *UK PD brain bank criteria [26, 27, 28] 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 [29]. 2. Hoehn and Yahr stage: less than 3 3. Disease duration: less than 3 years since disease diagnosis 4. Age: 40–80 years 5. Positive DaTscan™ SPECT by qualitative visual assessment from the Institute of Neurodegenerative Disorders. i. For women: If not surgically sterile or postmenopausal, a negative pregnancy test will be required prior to receiving the DaTscan™ SPECT. | |
Exclusion criteria | |
1. Currently being treated with PD medications such as levodopa or dopamine receptor agonists, MAO-B inhibitors, amantadine, or anticholinergics. 2. Expected to require treatment with medication for PD in the first 6 months of the study. 3. 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), Mucuna. 4. Duration of previous use of medications for PD exceeds 60 days. 5. 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. 6. 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. 7. Uncontrolled hypertension (resting blood pressure is greater than 150/90 mmHg). 8. 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 min of standing. 9. Hypo- or hyperthyroidism (TSH is less than 0.5 or is greater than 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 is less than 50mL/min, or estimated glomerular filtration rate using the MDRD4 equation or the CKD-EPI equation is less than 45 mL/min/1.73 m2). 10. Complete Blood Count (CBC) out of range and physician’s judgment that abnormal value is clinically significant. 11. Recent use of psychotropic medications (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants) where dosage has not been stable for 28 days prior to screening. 12. Serious illness (requiring systemic treatment and/or hospitalization) within the last 4 weeks. 13. 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. | 1. Montreal Cognitive Assessment (MoCA) score of less than 24. 2. Beck Depression Inventory II (BDI) score is greater than 28, indicating severe 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. 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) needs depression treatment modification currently or (3) depressive symptoms are 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. 3. Individuals who have been exercising at greater than moderate intensity for 120 min 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. 4. Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: bupropion, modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, any amphetamine or amphetamine derivative. These can compromise DaTscan™ SPECT. 5. Known allergy to iodinated products. 6. Known hypersensitivity to DaTscan™ SPECT (either to the active substance of 123I-ioflupane or any of the excipients). 7. (For women only) Actively breastfeeding an infant, and/or pregnant, or plan to become pregnant in the next 12 months. 8. Other disorders, injuries, diseases, or conditions that might interfere with the ability to perform endurance exercises (e.g., history of stroke, respiratory problems, traumatic brain injury, orthopedic injury, or neuromuscular disease). |