Recruiting

Exercise

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00387218

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Exercise, Physical therapy

Study Details

Brief summary:

This study is designed to compare three different exercise approaches to learn which program is best for people with early and mid-stage Parkinson's disease. Results from this study will help determine if participants can maintain the benefits from exercise and will help determine which program people with Parkinson's disease are more likely to continue using.

Conditions

Parkinson's Disease

Study ID

NCT00387218

Start date

Dec, 2002

Status verified date

May, 2008

Completion date

Apr, 2009

Anticipated

Primary completion date

Apr, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Inclusion Criteria: Community dwelling, independently ambulatory adults with mild to moderate PD (Stages 2, 2.5, and 3 on the modified Hoehn and Yahr scale) will be included. For inclusion, study subjects must have a diagnosis of PD made by their attending neurologist using criteria from the UK Brain Bank (e.g., at least two of the cardinal signs of PD \[i.e., bradykinesia, resting tremor, rigidity, postural instability\]); without PD medication other known or suspected causes of parkinsonism. They must be on a stable regimen for at least one month prior to enrollment, and must be receiving optimal medication management in the judgment of the examining neurologist.

Exclusion Criteria: Participants will be excluded if: on-state freezing; hospitalized within the previous three months, a score on the Folstein Mini-Mental Status Exam of less than 25 (indicating significant dementia); non-drug induced psychosis, or drug induced hallucinations, off periods of >25% time (UPDRS part IV)\[3\] or sub-optimal therapy of Parkinson's disease motor or non-motor symptoms; a second neurological disorder (e.g. stroke) with resulting motor involvement, or poorly controlled or unstable cardiovascular disease that precludes participation in the exercise program. In addition, participants will be excluded if they are participating in another trial except for those investigations that meet the following criteria: 1) PD Trial that is not related to the symptoms of PD (e.g., genetics of PD); 2) stable dose of an investigational medication given to treat motor symptoms of Parkinson's disease on an open-label basis or 3) in a trial that is not expected to affect PD or movement (e.g., hypertension, diabetes). They will be excluded if they cannot speak English and do not have adequate interpretation to participate in all aspects of the study.

Other exclusion criteria include presence of atypical parkinsonism syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic neurogenetic disorders (e.g., Wilson's disease), encephalitis, cerebrovascular, or degenerative disease (e.g. progressive supranuclear palsy, multiple system atrophy, vascular parkinsonism), history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant. Finally, participants will be excluded if they have any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality which would, in the judgement of the investigator, interfere with the subject's ability to participate in the study.

Additional exclusions are: 1) exercise limiting neuromuscular, joint/bone, cardiovascular, peripheral vascular, cerebrovascular or pulmonary disease; 2) abnormal treadmill stress test or contraindication to testing (recent MI, CHF, pulmonary embolus, significant aortic stenosis); 3) uncontrolled hypertension; 4) unstable diabetes or other endocrinopathy; 5) active liver disease (>3X normal LFTs); 6) major psychiatric illness that would affect the ability to understand and cooperate fully with the study protocol; 7) massive obesity (BMI>40); anemia; 8) consistent use of alcohol (>2 drinks/d); 9) involvement in an ongoing exercise program (>2Xwk for 20 min at an intensity that could produce sweating) in the last 6 months.

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Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Exercise, Physical therapy

Primary outcome measure

  • Balance (Functional Reach) [ Time Frame: undefined ]
  • Economy of movement (Oxygen consumption) [ Time Frame: undefined ]
  • Functional capacity (Continuous Scale Physical Functional Performance Test (Cs-PFP) [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Cory L Christiansen, PT, PhD

303-724-9101cory.christiansen@uchsc.edu

Locations

Waldron's Peak Physical Therapy

Recruiting

Boulder, Colorado, United States, 80303

Penrose Hospital

Recruiting

Colorado Springs, Colorado, United States, 80933

University of Colorado at Denver and Health Sciences Center

Recruiting

Denver, Colorado, United States, 80262

Carmody Recreation Center

Recruiting

Lakewood, Colorado, United States, 80227

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

May 23, 2008

Last verified

May, 2008

Keywords

  • Exercise
  • Physical Functional Ability
  • Spinal Range of Motion
  • Balance
  • Economy of Movement
  • Aerobic Conditioning
  • Quality of Life
  • Adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2008-05-23.