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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical therapy
Group Exercise Class
Home Program
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, PD, Exercise, Balance, Mobility

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Idiopathic Parkinson's disease

Exclusion Criteria:

  • Outside of the age range

Sites / Locations

  • OHSU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

One on one with a PT

Group exercise class

Home Program

Arm Description

The participant will work one-on-one with a trained for PT for 3 days a week for four weeks.

The participant will be in a group exercise class. That will meet 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.

Outcomes

Primary Outcome Measures

Physical Performance Test

Secondary Outcome Measures

UPDRS ADL and Motor UPDRS ADL and Motor
Timed up and Go Test with and without DT
Gait analysis
MiniBESTest
PDQ-39
LARS apathy scale
Activities of Balance confidence
Self-efficacy for exercise scale

Full Information

First Posted
May 17, 2011
Last Updated
October 6, 2017
Sponsor
Oregon Health and Science University
Collaborators
American Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT01361724
Brief Title
COPE-Co-morbidities, Parkinson's Disease and Exercise
Acronym
COPE
Official Title
COPE-Co-morbidities, Parkinson's Disease and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
American Physical Therapy Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, PD, Exercise, Balance, Mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One on one with a PT
Arm Type
Other
Arm Description
The participant will work one-on-one with a trained for PT for 3 days a week for four weeks.
Arm Title
Group exercise class
Arm Type
Other
Arm Description
The participant will be in a group exercise class. That will meet 3 days a week for 4 weeks.
Arm Title
Home Program
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy
Intervention Description
Physical therapy program for people with PD--one on one with a PT
Intervention Type
Behavioral
Intervention Name(s)
Group Exercise Class
Intervention Description
The participant will be in an exercise class for 3 days a week for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Home Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Performance Test
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
UPDRS ADL and Motor UPDRS ADL and Motor
Time Frame
4 wks
Title
Timed up and Go Test with and without DT
Time Frame
4 wks
Title
Gait analysis
Time Frame
4 wks
Title
MiniBESTest
Time Frame
4 wks
Title
PDQ-39
Time Frame
4 wks
Title
LARS apathy scale
Time Frame
4 wks
Title
Activities of Balance confidence
Time Frame
4 wks
Title
Self-efficacy for exercise scale
Time Frame
4 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Idiopathic Parkinson's disease Exclusion Criteria: Outside of the age range
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie King, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25102383
Citation
King LA, Priest KC, Nutt J, Chen Y, Chen Z, Melnick M, Horak F. Comorbidity and functional mobility in persons with Parkinson disease. Arch Phys Med Rehabil. 2014 Nov;95(11):2152-7. doi: 10.1016/j.apmr.2014.07.396. Epub 2014 Aug 4.
Results Reference
derived

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

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