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Strength Training and Medication Effects in Parkinson Disease Effects on Hypokinesia in Parkinson Disease
This study is currently recruiting participants.
Verified by University of Utah, April 2009
First Received: April 21, 2008   Last Updated: April 8, 2009   History of Changes
Sponsors and Collaborators: University of Utah
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Medical Rehabilitation Research
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00665184
  Purpose

Parkinson disease is a degenerative neurologic condition characterized by slowness of movement, tremor, and loss of balance control. It results in significant degrees of disability for affected individuals. Exercise and medication management are two treatments frequently used to treat Parkinson disease, and although some individuals benefit from these treatments, by what effect exercise works is presently not known. We will examine muscle structure and movement control responses to strengthening exercises and compare them to the therapeutic response observed as a result of medication intake. This process will allow us to better understand the mechanisms underlying the therapeutic effects of strengthening exercise for persons with Parkinson disease.


Condition Intervention
Parkinson Disease
Behavioral: Resistance Exercise via Negative Eccentric Work
Behavioral: Standard care exercise training

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Exercise and Physical Fitness Parkinson's Disease
Drug Information available for: Dopamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Official Title: High Force Resistance Training and Dopamine Replacement Effects on Hypokinesia in Parkinson Disease

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Hypokinesia as measured by movement kinematics and kinetics [ Time Frame: Pre intervention and post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional mobility as measured by gait / balance [ Time Frame: Pre intervention and post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Standard exercise care + high force lower extremity resistance training
Behavioral: Resistance Exercise via Negative Eccentric Work
High intensity resistance training delivered 2-3 times per week for 12 weeks
2: Active Comparator
Standard care exercise group
Behavioral: Standard care exercise training
Evidence based exercise training (resistance training, aerobic training, flexibility training) 2-3 times per week for 12 weeks.

Detailed Description:

Idiopathic Parkinson disease (IPD) is the model movement disorder to explore the motor function of the basal ganglia. (Morris ME, 2005) Alterations in the output of the basal ganglia lead to reductions in muscle force output and movement amplitude while inactivity and impaired mobility contribute to the loss of muscle size and strength.

Collectively these factors lead to reductions in the size and speed (hypokinesia) of functional movements such as gait. Hypokinesia during gait initiation and gait are biomechanical events that can precipitates movement deficits such as bradykinesia and falls. Previous studies have suggested that resistance training is beneficial in the management of persons with PD. Although anatomic, behavioral, and mobility related improvements have been demonstrated with resistance training intervention, it is unclear if the observed changes are derived solely from peripheral musculoskeletal changes or from central nervous system mediated alterations in force output and movement amplitude. The responsiveness of muscle force, movement amplitude, and hypokinesia to the CNS mediated effects of dopamine replacement provide a model system to which the effects of resistance training can be compared. In order to examine this question, we plan to conduct a controlled trial to rigorously examine the effects of high force resistance training on muscle structure, muscle force output, and hypokinesia in persons with moderate IPD and in the process, characterize the potentially differential effects of resistance training effects and dopamine replacement. This study assembles a team of investigators with experience in high force resistance training, measurement of the biomechanical and clinical balance function in persons with PD, and the statistical analysis expertise. Persons with IPD will be recruited, examined, and if they meet the inclusion criteria will be randomly assigned to one of two groups (experimental or standard care control). A battery of tests including muscle structure, muscle force production, and measures of hypokinesia and will be assessed on and off dopamine replacement medication both prior to and after a 12 week resistance training intervention. The first specific aim of the study is to determine if high force resistance training results in improvements in muscle structure, muscle force output, and hypokinesia in persons with moderate IPD. The second specific aim is to characterize and compare any differential effects of high force resistance training and dopamine replacement on muscle force output and hypokinesia in persons with moderate IPD. We hypothesize that dopamine replacement and resistance training will interact to improve muscle force output and reduce hypokinesia. In addition, we hypothesize that examination of kinematic patterns during gait initiation will reveal differential effects on lower extremity hypokinesia. The results of this study will help to better understand the differential contributions of resistance training and dopamine replacement on hypokinesia in persons with PD.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

male or a female at least 40 years of age or older neurologist diagnosed idiopathic PD (using UK Brain Bank Criteria) ambulatory and medically cleared by their physician to participate in an exercise regimen clinical signs of hypokinesia (reduced movement amplitude during ADL tasks) or postural instability have a Folstein Mini-Mental State Examination score > 23 currently taking dopamine replacement medication

Exclusion Criteria:

previous surgical management of PD (pallidotomy, DBS) motor fluctuations and or dyskinesias uncontrolled by medications. central nervous system disorder (e.g., other than Parkinson's disease) myopathic disease (e.g., focal myopathy) that affects skeletal muscle structure/function rheumatological disease that has an effect on muscle and/or mobility unstable cardiovascular disease that limits exercise abilities impaired knee flexion, <90 degrees, extreme claustrophobia (secondary to the inability to perform the MRI scans) regular (2-3x/week) aerobic or resistance exercise performed over the past 6 months

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665184

Contacts
Contact: Sheldon Smith 801-581-6696 sheldon.smith@hsc.utah.edu
Contact: Lee Dibble, PhD 801-581-4637 Lee.Dibble@hsc.utah.edu

Locations
United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Lee Dibble     801-581-4637     Lee.Dibble@hsc.utah.edu    
Contact: Lee Dibble     801-581-4637     Lee.Dibble@hsc.utah.edu    
Principal Investigator: Lee Dibble, PhD, PT            
Sponsors and Collaborators
University of Utah
National Center for Medical Rehabilitation Research
Investigators
Principal Investigator: Lee Dibble, PhD, PT University of Utah Department of Physical Therapy
  More Information

Publications:
Responsible Party: University of Utah Department of Physical Therapy ( Leland E Dibble / Associate Professor (Clinical) )
Study ID Numbers: IRB # 11900, 1 R15 HD056478-01
Study First Received: April 21, 2008
Last Updated: April 8, 2009
ClinicalTrials.gov Identifier: NCT00665184     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Hypokinesia
Gait
Quality of life
Dopamine replacement
Resistance training

Study placed in the following topic categories:
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Quality of Life
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Signs and Symptoms
Dopamine
Parkinson Disease
Movement Disorders
Neurologic Manifestations
Dopamine Agents
Parkinsonian Disorders
Hypokinesia

Additional relevant MeSH terms:
Signs and Symptoms
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases
Neurologic Manifestations
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Hypokinesia
Dyskinesias

ClinicalTrials.gov processed this record on May 07, 2009