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

NCT00665184 | Completed DMC

• 2 other identifiers: IRB # 119001R15HD056478-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Hypokinesia; Gait; Quality of life; Dopamine replacement; Resistance training

Outcome Measures

Primary Outcomes (1)

• Hypokinesia as measured by movement kinematics and kinetics

  Pre intervention and post intervention

Secondary Outcomes (1)

• Functional mobility as measured by gait / balance

  Pre intervention and post intervention

Study Arms (2)

High force LE resistance training

EXPERIMENTAL

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

Standard Care Control Group

ACTIVE COMPARATOR

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

Interventions

Resistance Exercise via Negative Eccentric Work BEHAVIORAL

High intensity resistance training delivered 2-3 times per week for 12 weeks

High force LE resistance training

Standard care exercise training BEHAVIORAL

Evidence based exercise training (resistance training, aerobic training, flexibility training) 2-3 times per week for 12 weeks.

Standard Care Control Group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (5)

• Dibble LE, Hale T, Marcus RL, Gerber JP, Lastayo PC. The safety and feasibility of high-force eccentric resistance exercise in persons with Parkinson's disease. Arch Phys Med Rehabil. 2006 Sep;87(9):1280-2. doi: 10.1016/j.apmr.2006.05.016.

  PMID: 16935068 BACKGROUND

• Dibble LE, Hale TF, Marcus RL, Droge J, Gerber JP, LaStayo PC. High-intensity resistance training amplifies muscle hypertrophy and functional gains in persons with Parkinson's disease. Mov Disord. 2006 Sep;21(9):1444-52. doi: 10.1002/mds.20997.

  PMID: 16773643 BACKGROUND

• Dibble LE, Hale TF, Marcus RL, Gerber JP, LaStayo PC. High intensity eccentric resistance training decreases bradykinesia and improves Quality Of Life in persons with Parkinson's disease: a preliminary study. Parkinsonism Relat Disord. 2009 Dec;15(10):752-7. doi: 10.1016/j.parkreldis.2009.04.009. Epub 2009 Jun 3.

  PMID: 19497777 BACKGROUND

• Foreman KB, Addison O, Kim HS, Dibble LE. Testing balance and fall risk in persons with Parkinson disease, an argument for ecologically valid testing. Parkinsonism Relat Disord. 2011 Mar;17(3):166-71. doi: 10.1016/j.parkreldis.2010.12.007. Epub 2011 Jan 6.

  PMID: 21215674 RESULT

• Dibble LE, Foreman KB, Addison O, Marcus RL, LaStayo PC. Exercise and medication effects on persons with Parkinson disease across the domains of disability: a randomized clinical trial. J Neurol Phys Ther. 2015 Apr;39(2):85-92. doi: 10.1097/NPT.0000000000000086.

  PMID: 25742370 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lee Dibble, PhD, PT

  University of Utah Department of Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: August 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

US (1)