COPE-Co-morbidities, Parkinson's Disease and Exercise
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

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 (PD). Although there is evidence that exercise can improve mobility in the elderly,
      the investigators 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
      PT intervention should be delivered to patients with chronic neurologic disease who also have
      other problems. The investigators will using elderly 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 1of 3 groups; home program, individual PT or group exercise class. Each of
      the 3 groups will be led by the same PT providing a novel sensory-motor agility program
      developed by our laboratory. All groups will perform the same type of exercises 3 X/week for
      4 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, 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.
    

Detailed description: 
      Specific Aims Effectiveness of Physical Therapy in chronic neurologic disease; the role of
      co-morbidities and delivery of PT services.

      Despite frequent referrals of people with chronic neurologic disease to outpatient physical
      therapy (PT) services, the relative effectiveness of various types of PT delivery for this
      population is uncertain. The investigators have encouraging data to support the effectiveness
      of a customized, evidence-based agility exercise program for patient's with Parkinson's
      disease but wonder whether less expensive modes of delivery of this PT service, a group
      program or independent, home exercise program could be as effective as individualized,
      one-on-one treatment by a physical therapist. Traditional studies of exercise in patients
      with chronic neurologic disease also tend to exclude subjects with co-morbidities, so common
      in complex, degenerative diseases, especially in the elderly so the extent to which the
      presence of co-morbidities determine success of PT services is also unknown. This proposal
      will use a randomized, intervention study to evaluate three modes of PT delivery of an
      agility exercise program to improve mobility of people with longstanding PD who also have at
      least one other significant co-morbidities. This study will help determine the optimal
      referral patterns for PT services in patients with complex, chronic problems affecting
      mobility.

      Aim 1. To determine the effects of differing modes of delivery for PT services on mobility
      disability, gait and balance in people with chronic neurologic disease. The investigators
      will examine the changes in disability as well as gait and balance performance measures
      before and after 4 weeks of exercise performed 3 times per week for a 1) home exercise
      program provided by a PT, 2) group PT-led exercise program, and 3) individual program. The
      primary outcome will be the Physical Performance Test of disability. Secondary outcome
      measures will provide information about the processes underlying effectiveness: an
      instrumented Timed up and go test and PDQ-39 for perceived mobility, mood, and cognitive
      deficits. The investigators will also compare adverse events and the number of exercise
      sessions that subjects miss because of complications from the exercise program as well as
      compliance, the number of PD subjects that drop out and do not maintain the 12-session,
      exercise programs.

      Aim 2. To determine how specific PD-related and age-related co-morbidities influence
      effectiveness of different types of PT delivery. The investigators will categorize the
      co-morbidities into those directly related to PD, including mental (depression, cognition),
      balance (falls and fractures) and autonomic (orthostatic hypotension) and those related to
      aging (peripheral neuropathy, pain and muscle weakness). The investigators will determine if
      the number and type of such co-morbidities influence the outcome of each exercise program.

      This project has great clinical significance for rehabilitation of elderly people with
      chronic, complex neurologic disease. The information from this study will influence how to
      best approach physical therapy services to improve mobility in patient with complex problems
      affecting their balance and gait.
    

Intervention name(s): Physical therapy; Group Exercise Class; Home Program
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Physical therapy program for people with PD--one on one with a PT; The participant will be in an exercise class for 3 days a week for 4 weeks.; The participant will meet one time with a physical therapist and will be given a home program--which is standard of care--to follow for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; PD; Exercise; Balance; Mobility