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Official Study Title: The effects of agility training vs treadmill training for PD
Sponsor: American Physical Therapy  TherapyAnother word for “treatment”. Association
Clinicaltrials.gov ID: NCT01361724
Study ID: 4402

Summary

Problems with balance and walking that affect mobility are an inevitable cause of decreased quality of life in older people with chronic neurologic conditions such as 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). Although there is evidence that exercise can improve mobility in the elderly, the investigators of this study don't know: 1) What is the best mode of exercise intervention delivery (i.e. individual therapy in a clinic, home exercise program, or a group class)? and 2) How do other problems common in people with PD and/or the elderly affect outcomes?

Although most physical therapy is carried out individually, a group or home program would be most cost-effective so the investigators need to know if they are just as effective. Since most older people with chronic neurologic diseases also have other problems affecting mental function, muscles and joints and/or pain, it is important to understand how these other problem affect the success of their therapy.

The purpose of this study is to investigate how physical therapy intervention should be delivered to patients with chronic neurologic disease who also have other problems. The study is open to people with PD who have one or more co-morbidities associated with PD and/or aging. Sixty people PD and co-morbidities will be randomized into one of  three groups; home program, individual physicial therapy or group exercise class. Each of the three groups will be led by the same physical therapist providing a novel sensory-motor agility program. All groups will perform the same type of exercises three times a week for four weeks. Improvement in the Physical Performance Test of disability will be used to determine the success of therapy. To determine how and why mobility was improved by therapy, changes in 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. balance, and quality of life will be measured. Gait and balance will be measured with new, wearable motion sensors (iPod size) while standing up from a chair, walking, turning around and sitting back down. The findings from this study will help guide rehabilitation treatment for complex, chronic problems affecting mobility in older people.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Study does not address symptoms

General PD symptoms, Balance, Loss of Motor Skills, Walking/Gait

Time Commitment

• Less than six months
• A pre-test (two- to three-hour visit) the week before the exercise starts and a post-test the week after the exercise ends (two- to three-hour visit). Participation in this study requires being randomized into one of three exercise groups and potentially going to OHSU to participate in the exercise program, three times a week for four weeks. Transportation will not be provided and you will be paid for participation.

Eligibility

• Minimum Age: 40
• Maximum Age: 80
• Gender(s) Accepted: Either

Inclusion Criteria

• People who have a diagnosis of idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. Parkinson’s disease
• People who have transportation to and from OHSU

Exclusion Criteria

• People who exercise more than 10 hours a week or have a current exercise class that conflicts during the exercise study visit
• People who are currently enrolled in another research study or have participated in another exercise study in the last year

Enrollment

Expected Enrollment: 62 (US)
Date Enrollment Began: Apr 2011
Date Enrollment Ends: Apr 2012
Last Updated Date: Aug 01 2011
Trial Post Date: Aug 01 2011
Website: http://clinicaltrials.gov/ct2/show/NCT01361724

Primary Contacts and Locations

Oregon

• Kelsey Priest
  Oregon Health & Science University
  priest@ohsu.edu
  Phone: (503) 575-8401
  Mail code OP32
  3181 SW Sam Jackson Park Road
  Portland, OR 97239
  USA