COPE-Co-morbidities, Parkinson's Disease and Exercise

This study has been completed.
Sponsor:
Collaborator:
American Physical Therapy Association
Information provided by (Responsible Party):
Laurie King, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01361724
First received: May 17, 2011
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Parkinson's Disease
Behavioral: Physical therapy
Behavioral: Group Exercise Class
Behavioral: Home Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COPE-Co-morbidities, Parkinson's Disease and Exercise

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • UPDRS-Motor Evaluation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease Rating Scale--this scale is the current gold standard for monitoring and evaluating disease progression/symptoms of Parkinson's disease. We will observe any changes in the UPDRS from pre and post exercise as an outcome measure.

  • Timed up and Go Test (instrumented) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Th instrumented timed up and go test will measure mobility, balance and gait during the task of sit to stand, walk and sit back down. Specific measures such as; gait velocity, symmetry of gait and duration of turn will be observed for any changes after exercise intervention.


Enrollment: 58
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
One on one with a PT
The participant will work one-on-one with a trained for PT for 3 days a week for four weeks.
Behavioral: Physical therapy
Physical therapy program for people with PD--one on one with a PT
Group exercise class
The participant will be in a group exercise class. That will meet 3 days a week for 4 weeks.
Behavioral: Group Exercise Class
The participant will be in an exercise class for 3 days a week for 4 weeks.
Home Program
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.
Behavioral: Home Program
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Idiopathic Parkinson's disease

Exclusion Criteria:

  • Outside of the age range
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361724

Locations
United States, Oregon
OHSU
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
American Physical Therapy Association
Investigators
Principal Investigator: Laurie King, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Laurie King, Assistant Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01361724     History of Changes
Other Study ID Numbers: 4022
Study First Received: May 17, 2011
Last Updated: August 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Oregon Health and Science University:
Parkinson's disease
PD
Exercise
Balance
Mobility

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 27, 2014