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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lee Dibble, University of Utah
ClinicalTrials.gov Identifier:
NCT00665184
First received: April 21, 2008
Last updated: September 20, 2011
Last verified: September 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Force Resistance Training and Dopamine Replacement Effects on Hypokinesia in Parkinson Disease

Resource links provided by NLM:


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 ]

Enrollment: 41
Study Start Date: August 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Locations
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Lee Dibble, PhD, PT University of Utah Department of Physical Therapy
  More Information

Publications:
Responsible Party: Lee Dibble, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00665184     History of Changes
Other Study ID Numbers: IRB # 11900, 1R15HD056478-01
Study First Received: April 21, 2008
Last Updated: September 20, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 18, 2014