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Strength Training and Medication Effects in Parkinson Disease Effects on Hypokinesia in Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00665184
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : September 21, 2011
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Lee Dibble, University of Utah

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Resistance Exercise via Negative Eccentric Work Behavioral: Standard care exercise training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Force Resistance Training and Dopamine Replacement Effects on Hypokinesia in Parkinson Disease
Study Start Date : August 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: High force LE resistance training
High force lower extremity resistance training + Standard exercise care. The high force lower extremity resistance training group will participate in a 3 day per week progressive eccentric ergometry program that will be gradually increased over 3 weeks from 5-20 minutes per day and remain at that duration for the next 9 weeks. In addition, they will engage in exercises including moderate intensity aerobic training, concentric upper extremity resistance training and stretching (axial mobility exercises).
Behavioral: Resistance Exercise via Negative Eccentric Work
High intensity resistance training delivered 2-3 times per week for 12 weeks

Active Comparator: Standard Care Control Group
Standard care exercise group: The standard care control group is an "active control group", i.e., individuals who will engage in our standard of care (an evidence based exercise program). These exercises include moderate intensity aerobic training (15 minutes), concentric upper extremity resistance training (5-10 minutes), balance training (5 minutes), and stretching (axial mobility exercises-5-10 minutes).
Behavioral: Standard care exercise training
Evidence based exercise training (resistance training, aerobic training, flexibility training) 2-3 times per week for 12 weeks.

Primary Outcome Measures :
  1. Hypokinesia as measured by movement kinematics and kinetics [ Time Frame: Pre intervention and post intervention ]

Secondary Outcome Measures :
  1. Functional mobility as measured by gait / balance [ Time Frame: Pre intervention and post intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00665184

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United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Lee Dibble, PhD, PT University of Utah Department of Physical Therapy
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lee Dibble, Associate Professor, University of Utah Identifier: NCT00665184    
Other Study ID Numbers: IRB # 11900
1R15HD056478-01 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: September 2011
Keywords provided by Lee Dibble, University of Utah:
Quality of life
Dopamine replacement
Resistance training
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations