The Effect of Exercise on Individuals With Parkinson's Disease

University of Illinois

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: Progressive resistance training; Behavioral: Modified Fitness Counts

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00591344

R01NS028127

5R01NS028127-16 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 50 to 67 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Progressive resistance training

Active Comparator group

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.

Treatment:

Behavioral: Progressive resistance training

Modified Fitness Counts

Active Comparator group

Description:

Subjects will perform between 60 and 90 minutes of modified Fitness Counts 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.

Treatment:

Behavioral: Modified Fitness Counts