- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01361724
COPE-Co-morbidities, Parkinson's Disease and Exercise (COPE)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- OHSU
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Idiopathic Parkinson's disease
Exclusion Criteria:
- Outside of the age range
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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.
|
Physical therapy program for people with PD--one on one with a PT
|
OTHER: Group exercise class
The participant will be in a group exercise class.
That will meet 3 days a week for 4 weeks.
|
The participant will be in an exercise class for 3 days a week for 4 weeks.
|
OTHER: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical Performance Test
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
UPDRS ADL and Motor UPDRS ADL and Motor
Time Frame: 4 wks
|
4 wks
|
Timed up and Go Test with and without DT
Time Frame: 4 wks
|
4 wks
|
Gait analysis
Time Frame: 4 wks
|
4 wks
|
MiniBESTest
Time Frame: 4 wks
|
4 wks
|
PDQ-39
Time Frame: 4 wks
|
4 wks
|
LARS apathy scale
Time Frame: 4 wks
|
4 wks
|
Activities of Balance confidence
Time Frame: 4 wks
|
4 wks
|
Self-efficacy for exercise scale
Time Frame: 4 wks
|
4 wks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laurie King, PhD, Oregon Health and Science University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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