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Official Study Title: Parkinson's Recovery Of Brain With Exercise (P.R.O.B.E.)
Sponsor: American Physical Therapy  TherapyAnother word for “treatment”. Association, Charles Magistro Fund
Clinicaltrials.gov ID:
Study ID: HS-038-026

Summary

The purpose of this study is to advance findings from the investigators’ preliminary data to elucidate underlying mechanisms of exercise which may mediate brain repair (neuroplasticity) in people with PD. Specifically they will test the hypothesis that high intensity exercise in persons with early Parkinson’s disease (PD) leads to neuroplasticity, or the brain's natural ability to form new connections in order to compensate for injury or changes in one's environment. Twenty-four participants with early stage PD will be randomly assigned to one of two intense exercise groups or a control group.  Control Group (Comparison Group)Clinical trial participants who are given either a standard treatment or a placebo instead of the investigational drug or treatment being tested. Both exercise groups will train with a doctor of physical therapy one hour three times per week for six weeks. One exercise group will receive intensive training utilizing a body weight-supported treadmill, and the other exercise group will receive intense overground training using the Walk Big therapy approach developed by Dr. Becky Farley, PhD, PT. Participants walk across a five meter walkway while responding to cues to turn, stop, and to walk as fast as possible while their motor performance is evaluated). Traditionally, physical therapy is prescribed for individuals with late PD. By demonstrating both brain and functional improvements in early PD, one can argue the need for early exercise intervention that is intense, continuous, may alter disease progression, and delay the need for drug therapies. By understanding the underlying brain mechanisms associated with exercise, novel pharmacological and non-pharmacological therapies may be designed to delay or reverse disease progression in PD. In addition and for the future, exercise may be determined to enhance the effects of other interventions.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Movement Symptoms

Balance, Freeze Attacks,  Freeze AttacksThe sudden loss of ability to move. Postural difficulties, Rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Walking/Gait  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms.

Time Commitment

• Less than six months
• Baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. evaluations, 2-3 days; Treatment intervention: 3 times/week for 6 weeks; Post Treatment evaluations, 2-3 days Total time: 8 weeks

Eligibility

• Minimum Age: 18
• Gender(s) Accepted: Either
• Maximum Years Since Diagnosis: 3

Inclusion Criteria

• Diagnosed with PD 3 years ago or less
• Must be medically stable and optimized on their medications
• Must be able to walk 10 meters
• Reported gait abnormalities since receiving diagnosis
• Not currently receiving any physical therapy nor participating in any other clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. trial
• Must have medical clearance from their primary care physician to participate in the physical therapy exercise intervention

Exclusion Criteria

• Severe cardiac disease
• Severe systolic blood pressure reduction with standing (orthostatic hypotension)
• A history of poorly controlled or brittle diabetes
• A history of lower limb amputation
• Been prescribed any new dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. replacement medications or new mood stabilizer medications
• A history of previous gait disorder from any cause
• History of falls or poor balance
• Musculoskeletal impairments that limit full knee or ankle motion
• Presence of a lower limb non-healing ulcer
• Poor cognition
• The presence of any medical condition which the investigator believes might present an unacceptable health risk to the person should they participate in the study
• Electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
• Metal in any part of the body including metal injury to the eye
• History of brain lesions (such as stroke), seizures, or unexplained spells of loss of consciousness
• Pregnant or breast-feeding

Enrollment

Expected Enrollment: 24
Date Enrollment Began: Jan 01 2008
Last Updated Date: Jun 06 2008
Trial Post Date: Jun 06 2008
Website: http://pt.usc.edu/phillips-fisher

Primary Contacts and Locations

California

• Jeanine O. Yip, DPT, NCS — Study Coordinator
  USC Division of Biokinesiology and Physical Therapy
  jeaniney@usc.edu
  Phone: (213) 399-1508
  1540 E. Alcazar Street, CHP 155
  Los Angeles, CA 90033
  USA