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Official Study Title: The Therapeutic Effects of Exercise on Parkinson’s Disease
Sponsor: National Institutes of Health
Clinicaltrials.gov ID:
Study ID: 09-439

Summary

The purpose of the project is to gain a better understanding of how exercise training affects motor function (e.g. hand function) and brain function in people diagnosed with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD).  The investigators want to study if the exercise will improve hand function and brain activity.  In order to measure this, the investigators will ask the participants to have five biomechanical and clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. assessments and three fMRI over the course of the study.

Participants will be randomly assigned to one of three groups:

• Voluntary Exercise
• Assisted Exercise
• No Exercise

If a participant is assigned to an exercise group, they will be asked to complete a series of exercise training sessions three times a week, one hour in length, for eight weeks.  During training, the participant will be asked to exercise at a moderate to hard level for 40 minutes with a ten minute warm-up and ten minute cool-down.  Manual dexterity will be tested at five intervals throughout the study.

Study Phase

Phase 1/2
What is a study phase?

Symptoms Addressed: Movement Symptoms

General PD symptoms, Loss of Motor Skills, 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. , Tremor,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. 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
• 29 visits required over a period of 17 weeks

Eligibility

• Minimum Age: 30
• Maximum Age: 75
• Gender(s) Accepted: Either

Inclusion Criteria

• Clinical diagnosis of idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. PD

Exclusion Criteria

• Individuals with existing cardiopulmonary disease or stroke
• Individuals with dementia,  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. Individuals with any medical or musculoskeletal contraindications to exercise

Enrollment

Expected Enrollment: 60 (US)
Date Enrollment Began: Apr 2010
Date Enrollment Ends: Dec 2011
Last Updated Date: May 11 2010
Trial Post Date: Aug 27 2009
Website:

Primary Contacts and Locations

Ohio

• Mandy Penko, M.A.
  Cleveland Clinic
  penkoa@ccf.org
  Phone: (216) 636-9717/(702) 483-6004
  ND/20 9500 Euclid Ave.
  Cleveland, OH 44195
  USA
  
• Liz Jansen
  Cleveland Clinic
  jansena@ccf.org
  Phone: (216) 445-3866
  ND/20 9500 Euclid Ave
  Cleveland, OH 44195
  USA
  

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