This trial is active, not recruiting.

Condition parkinson disease
Treatments moderate exercise, vigorous exercise, no intervention
Phase phase 2
Sponsor University of Colorado, Denver
Collaborator University of Illinois at Chicago
Start date April 2012
End date May 2016
Trial size 129 participants
Trial identifier NCT01506479, 11-1237, R01NS074343


The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Sham Comparator)
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
no intervention
No-exercise control (i.e., usual care);
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
vigorous exercise
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Endurance exercise at 60-65% HR max, 4x/wk for 6 months.
moderate exercise
Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.

Primary Outcomes

Adherence to exercise
time frame: 6 months

Secondary Outcomes

Potential for therapeutic efficacy
time frame: 6 months

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Clinical diagnosis of primary Parkinson's disease - In a Hoehn and Yahr stage less than stage III - Disease duration is less than 5 years - Not likely to require dopaminergic therapy within 6 months Exclusion Criteria: - Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl). - Duration of previous use of medications for PD that exceeds 90 days - Expected to require dopaminergic therapy in the next 6 months - Poorly controlled or unstable cardiovascular disease - Uncontrolled hypertension - Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function - Mild cognitive impairment (Montreal Cognitive Assessment score<26/30) - Depression that precludes ability to exercise (Beck depression score>13) - Disorders that interfere with ability to perform endurance exercises - Regular participation in vigorous endurance exercise - Evidence of serious arrhythmias or ischemic heart disease - Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study

Additional Information

Official title Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease
Principal investigator Margaret Schenkman, PT, PhD
Description The overall objective of this Phase II study is to determine the futility or non-futility of conducting a Phase III randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.