Study in Parkinson's Disease of Exercise

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: No Intervention; Behavioral: Vigorous Exercise; Behavioral: Moderate Exercise

• Registration Number: NCT01506479
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

The overall objective of this study is to determine the futility or non-futility of conducting a 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.

Study Timeline

• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-10
• Study Start: 2012-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-06-23
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Results First Posted: 2017-10-13
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	No Intervention	Wait listed to moderate or vigorous exercise after 6 months of no exercise.
Vigorous Exercise	Vigorous Exercise	Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
Moderate Exercise	Moderate Exercise	Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise	9 to 26 weeks	To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.

Secondary Outcome Measures

Name	Time	Method
6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score	Baseline and 6 months	Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.

Trial Locations

Locations (3)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Illinois, Chicago; 🇺🇸 Chicago, Illinois, United States