Study in Parkinson Disease of Exercise

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    370
  • sponsor
    Northwestern University
Updated on 4 June 2021

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.

Description

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. Tertiary objectives will test hypotheses related to 2 characteristics of ambulation 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 specialists.

Details
Condition Parkinson's disease
Treatment Treadmill walking
Clinical Study IdentifierNCT04284436
SponsorNorthwestern University
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

Inclusion 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

Exclusion Criteria

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)
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 (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, 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 <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
Individuals participating in 120 minutes or more of moderate intensity exercise per week within the last 6 months will be excluded. Moderate intensity is defined as a range greater than 60-65% HRmax. These individuals are excluded since their exercise activities are equal to or greater than 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) 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)
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