Chicago, Illinois 60612


Purpose:

The goal of this trial is to compare the effect of two different exercise programs on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease to determine which program is most beneficial.


Study summary:

Parkinson's disease (PD) negatively affects the quality of life for a million individuals in the United States. While medication and surgery are the most effective treatments for PD, physicians and people with PD often delay using these treatments because of their considerable adverse side effects. Until a cure for PD is discovered, there is a compelling need to develop interventions that provide relief of symptoms without causing negative side effects. Recent research suggests that exercise may provide symptom relief in some characteristics of PD. While various exercise interventions appear to effectively improve motor, functional, and quality-of-life issues, the research is mixed regarding the nature, extent and duration of these improvements. Understanding how multiple characteristics of PD change and whether they can be modified by different exercise programs is essential to determining if an exercise program is clinically effective for PD. This study is designed to compare the initial (six months), and then long-term (2 years) effect that 2 different exercise programs (progressive resistance program or flexibility program) have on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease. The goal is to determine which program is most beneficial. Results from this study will be used to determine which exercise program produces the most beneficial effects on neuro-physiological, motor, functional and quality-of-life measures. NOTE: Recruitment for Parkinson's disease participants is now closed. However, recruitment for healthy control participants continues.


Criteria:

Inclusion Criteria: - a diagnosis of PD - Up to the age of 67 - on at least 1 DA drug, may be on several PD medications - able to walk for six minutes (may take rest breaks) - able to come off their PD medication for testing (12 hour overnight withdrawal of antiparkinsonian medications) - able to stay on stable PD medications for at least 6 months - live within a 30 mile radius of Chicago - Hoehn and Yahr Score: II - III while in the "Off" PD medication state Exclusion Criteria: - history of any other neurological disorder as determined by medical history and neurological exam - history of a known injury, disease, or other disorder that might interfere with motor function in the proposed experiments - a score less than 23 on the Mini-Mental State Examination - currently involved in an active, ongoing formal exercise program deep brain stimulation surgery - known cardiac problem or significant hypertension - depression that may interfere with regular exercise - hallucinations or being treated for hallucinations


Study is Available At:


Original ID:

R01NS28127


NCT ID:

NCT00591344


Secondary ID:

RO1 NS 28127-12


Study Acronym:


Brief Title:

The Effect of Exercise on Individuals With Parkinson's Disease


Official Title:

The Effect of Exercise on Individuals With Parkinson's Disease


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

50 Years


Maximum Age:

67 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Illinois


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Daniel Corcos, Ph.D.
Principal Investigator
University of Illinois, Chicago
Primary Contact:Julie A Robichaud, PT, Ph.D.,
708-507-0154
jrobicha@uic.edu

Study Dates

Start Date:October 2007
Completion Date:June 2011
Completion Type:Anticipated
Primary Completion Date:January 2011
Primary Completion Type:Anticipated
Verification Date:June 2010
Last Changed Date:June 24, 2010
First Received Date:December 26, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:UPDRS (motor scale)
Time Frame:obtained during initial evaluation & every 6 six months to end of 2-yr training period
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Relaxation time
Time Frame:obtained during an initial evaluation and every 6 six months until the end of the 2 year training pe
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Duration of First agonist burst
Time Frame:obtained during an initial evaluation and every 6 six months until the end of the 2 year training pe
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Percentage of trials with short first agonist burst durations
Time Frame:obtained during an initial evaluation and every 6 six months until the end of the 2 year training pe
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Berg Balance Scale Score
Time Frame:obtained during an initial evaluation and every 6 six months until the end of the 2 year training pe
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Preferred walking speed
Time Frame:obtained during an initial evaluation and every 6 six months until the end of the 2 year training pe
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Distance walked in 6 minutes
Time Frame:obtained during an initial evaluation and every 6 six months until the end of the 2 year training pe
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Elbow flexion strength
Time Frame:obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Elbow extension strength
Time Frame:obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Ankle dorsiflexion strength
Time Frame:obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Ankle plantar flexion strength,
Time Frame:obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of agonist EMG signal contained in 5-15 Hz frequency bin during isometric contractions
Time Frame:obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Peak movement velocity
Time Frame:obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time spent in double limb support during walking
Time Frame:obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time on the timed up and go test
Time Frame:obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Exercise - Progressive resistance and flexibility
Description:Exercise twice a week for 2 years doing either progressive resistance training or flexibility training
Arm Name:1 (progressive resistance training)

Study Arms

Study Arm Type:Active Comparator
Arm Name:2 (flexibility training)
Description:Subjects will perform between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Study Arm Type:Active Comparator
Arm Name:1 (progressive resistance training)
Description:Subjects will perform between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Illinois
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Neurological Disorders and Stroke (NINDS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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