• PDtrials - Parkinson's Disease Clinical Trials
• /Browse All Trials

Official Study Title: Effects of Aerobic Exercise in Parkinson's Disease
Sponsor: Department of Veterans Affairs, Rehabilitation Research and Development; University of Iowa
Clinicaltrials.gov ID: NCT00784563
Study ID: B6261R

Summary

Many people with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD), even in the early stages, suffer from cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. dysfunction, which can impair activities of daily living such as driving. Modest increases in cardiovascular fitness with aerobic exercise improve executive functions and visuospatial abilities (abilities to perceive spatial relationships between objects) in the normal elderly. Preliminary studies have shown that people with mild to moderate PD tolerate aerobic exercise programs and show cardiovascular fitness and motor function improvements.

In a pilot study of independently living, fully ambulatory (mobile) people with PD across a spectrum of physical activity levels, Dr. Uc and his collaborators found that cardiovascular fitness was a predictor of executive functions, visuospatial abilities, walking speed, level of physical activity, and activities of daily living, even after adjusting for age, education, and motor severity of PD. Participants with greater fitness and better performance on an executive function task had more favorable brain activity patterns on functional MRI (magnetic resonance imaging,  Magnetic Resonance Imaging (MRI)A non-invasive technique that uses magnetism to create detailed pictures of the inside of the human body. a neuroimaging  NeuroimagingNon-invasive techniques (e.g. computed tomography, magnetic resonance imaging, and positron-emission tomography) for measuring brain structure and function that may reveal important insights into aspects of PD not directly related to biomarkers and treatment trials. technique).

The hypotheses are that: 1) Aerobic exercise intervention in the form of brisk walking will improve cardiovascular fitness and cognitive function in PD, and 2) Aerobic exercise programs using different training formats and settings will have different adverse effects, tolerability, and neurobiological activity.

This Phase I/II clinical trial  Clinical Trial (Clinical Study)A scientific study involving human participants to determine the safety and efficacy of new therapies or new ways of using known treatments. is aimed at determining the safest and most tolerable aerobic exercise intervention with best neurobiological activity so that this intervention can be tested for efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. in a subsequent definitive clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. trial (a Phase III) trial.

One hundred independently living, fully ambulatory, people with PD who are not on an aerobic exercise program will be enrolled in this study.

Study Phase

Phase 1/2
What is a study phase?

Symptoms Addressed: Movement and Non-movement

Cognitive Moods, Depression, General PD symptoms, Loss of Energy, Loss of Motor Skills, Memory, Walking/Gait  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms.

Time Commitment

• Six months
• Exercise programs will be conducted times times per week.

Eligibility

• Minimum Age: 50
• Maximum Age: 80
• Gender(s) Accepted: Either

Inclusion Criteria

• Veteran or non-veteran;
• Presence of all 3 cardinal features of PD (resting tremor,  Resting TremorA tremor of a limb that increases when the limb is at rest. bradykinesia,  BradykinesiaSlowness of movement. and rigidity)  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. , which have to be asymmetrical;
• Capable of performing the planned exercise programs;
• Intention to remain in the local area over the study period;
• Stable dopaminergic treatment regimen for at least 4 weeks prior to baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. without any clinical need for medication adjustment at the time of screening.  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA.

Exclusion Criteria

• Secondary parkinsonism;
• Parkinson-plus syndromes;
• Participating in a aerobic exercise program;
• An unstable dosage of drugs active in the central nervous system (e.g., anxiolytics, antidepressants) during the 60 days before the baseline visit;
• Participation in drug studies or the use of investigational drugs within 30 days before screening;
• Structural brain disease;
• Active epilepsy;
• Acute illness or active, confounding medical, neurological, or musculoskeletal conditions;
• Alcoholism or other forms of drug addiction;
• Inability to complete the graded exercise test;
• Lack of medical clearance from our pulmonologist;
• Intention to move or take a vacation of more than one month during the study period;
• Contraindications to (medical reason to not administer) MRI or claustrophobia requiring sedation.

Enrollment

Expected Enrollment: 100 (US)
Date Enrollment Began: Feb 2008
Date Enrollment Ends: Mar 2012
Last Updated Date: May 06 2011
Trial Post Date: Dec 22 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00784563?term=NCT00784563&rank=1

Primary Contacts and Locations

Iowa

• Ergun Y. Uc, MD
  University of Iowa
  ergun-uc@uiowa.edu
  Phone: (319) 356-8754
  Iowa City, IA 52246
  USA