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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
Treadmill walking 4 days per week for 30 minutes in the target heart rate
University of Alabama at Birmingham
Birmingham, Alabama, United States
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.
Time frame: 12 months
Change in dopaminergic activity
Change from baseline in the striatal specific binding ratio (SSBR) as measured by dopamine transporter imaging
Time frame: 12 months
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.
Time frame: 18 months
Change in walking capacity
Change from baseline in distance in 6-minute walk
Time frame: 12 months
Change in walking capacity
Change from baseline in distance in 6-minute walk
Time frame: 18 months
Change in activity
Change from baseline in the number of steps
Time frame: 12 months
Change in activity
Change from baseline in the number of steps
Time frame: 18 months
Change in cognitive function
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370
University of California, San Francisco
San Francisco, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Iowa State University
Ames, Iowa, United States
Louisiana State University
Baton Rouge, Louisiana, United States
...and 15 more locations
Change from baseline in the Montreal Cognitive Assessment (MoCA). MoCA scores range between 0 and 30, with higher scores representing a better outcome.
Time frame: 12 months
Change in cognitive function
Change from baseline in the Montreal Cognitive Assessment (MoCA). MoCA scores range between 0 and 30, with higher scores representing a better outcome.
Time frame: 18 months
Change in fitness
Change from baseline in maximal oxygen consumption measured with peak oxygen volume
Time frame: 12 months
Change in fitness
Change from baseline in maximal oxygen consumption measured with peak oxygen volume
Time frame: 18 months
Change in quality of life
Change from baseline in quality of life measured with the Parkinson Disease Questionnaire-39. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month covering 8 dimensions scored on a 5 point ordinal system (0=never, 4=always). Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better QoL. Overall score can be summarized in the Parkinson's Disease Summary Index (PDSI) or PDQ-39 Summary Index (PDQ-39 SI).PDSI or PDQ-39 SI = sum of dimension total scores divided by 8.
Time frame: 12 months
Change in quality of life
Change from baseline in quality of life measured with the Parkinson Disease Questionnaire-39. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month covering 8 dimensions scored on a 5 point ordinal system (0=never, 4=always). Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better QoL. Overall score can be summarized in the Parkinson's Disease Summary Index (PDSI) or PDQ-39 Summary Index (PDQ-39 SI).PDSI or PDQ-39 SI = sum of dimension total scores divided by 8.
Time frame: 18 months
Initiation of dopaminergic therapy
Time to initiation of dopaminergic therapy
Time frame: 12 months
Change in blood derived marker of inflammation
Change from baseline in C-reactive protein
Time frame: 12 months
Change in blood derived marker of inflammation
Change from baseline in C-reactive protein
Time frame: 18 months
Change in blood derived marker of neuronal development
Change from baseline in brain derived neurotrophic factor (BDNF)
Time frame: 12 months
Change in blood derived marker of neuronal development
Change from baseline in brain derived neurotrophic factor (BDNF)
Time frame: 18 months