Exercise Study For People With Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00387218
First received: October 11, 2006
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Parkinson's Disease
Behavioral: Exercise, Physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Exercise, Physical Function, and Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Balance (Functional Reach)
  • Economy of movement (Oxygen consumption)
  • Functional capacity (Continuous Scale Physical Functional Performance Test (Cs-PFP)

Secondary Outcome Measures:
  • UPDRS Motor subscale
  • UPDRS ADL subscale
  • Quality of life (PDQ-39)
  • Spinal Range of Motion (Functional Axial Rotation, FAR)
  • VO2 submax

Estimated Enrollment: 170
Study Start Date: December 2002
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

This is an intervention study that will determine whether an exercise program targeting spinal extremity range of motion for individuals with Parkinson's Disease, is superior to general conditioning and to 'usual care'. This study builds on previous findings of Schenkman and colleagues including the following: loss of spinal and extremity range of motion occur as sequelae to PD; these losses contribute significantly to early impairments of balance; and both spinal range of motion and balance of people with economy of movement is impaired in people who have PD. Specifically, we will examine whether the intervention, targeting range of motion and balance, also improves economy of movement.

Untreated impairments of range of motion, balance, and economy of movement may become highly disabling. Short term improvements of range of motion and balance occur with exercise. If the patient can sustain such improvements after a supervised exercise program is completed, these functionally limiting impairments may be delayed. Additionally, if exercises for spinal range of motion are coupled with functional retraining, the patient should improve in overall physical functional ability. Therefore, this study will establish the overall impact of a targeted exercise program for people with PD in terms of balance, economy of movement, and overall functional ability.

The study is a randomized clinical trial, with three treatment arms and four repeated measures: before treatment, after treatment, and follow-up after 10 months and again after 16 months. This study compares usual care based on the National Parkinson's Foundation, aerobic training, and targeted flexibility and functional training. The primary outcomes are measures of overall functional ability, balance and economy of movement. Secondary outcomes include measures of disease state, spinal range of motion, aerobic capacity, and quality of life.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387218

Contacts
Contact: Cory L Christiansen, PT, PhD 303-724-9101 cory.christiansen@uchsc.edu

Locations
United States, Colorado
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
Sponsors and Collaborators
Investigators
Principal Investigator: Margaret L Schenkman, PhD, PT University of Colorado, Denver
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00387218     History of Changes
Other Study ID Numbers: R01HD043770, COMIRB #02-750
Study First Received: October 11, 2006
Last Updated: May 21, 2008
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Exercise
Physical Functional Ability
Spinal Range of Motion
Balance
Economy of Movement
Aerobic Conditioning
Quality of Life
Adherence

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 21, 2014