Strength Training and Medication Effects in Parkinson Disease Effects on Hypokinesia in Parkinson Disease
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|ClinicalTrials.gov Identifier: NCT00665184|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : September 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Behavioral: Resistance Exercise via Negative Eccentric Work Behavioral: Standard care exercise training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Hypokinesia as measured by movement kinematics and kinetics [ Time Frame: Pre intervention and post intervention ]
- Functional mobility as measured by gait / balance [ Time Frame: Pre intervention and post intervention ]
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 ClinicalTrials.gov identifier (NCT number): NCT00665184
|United States, Utah|
|University of Utah Health Sciences Center|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Lee Dibble, PhD, PT||University of Utah Department of Physical Therapy|