NCT01361724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

May 17, 2011

Last Update Submit

October 6, 2017

Conditions

Keywords

Parkinson's diseasePDExerciseBalanceMobility

Outcome Measures

Primary Outcomes (1)

  • Physical Performance Test

    4 weeks

Secondary Outcomes (8)

  • UPDRS ADL and Motor UPDRS ADL and Motor

    4 wks

  • Timed up and Go Test with and without DT

    4 wks

  • Gait analysis

    4 wks

  • MiniBESTest

    4 wks

  • PDQ-39

    4 wks

  • +3 more secondary outcomes

Study Arms (3)

One on one with a PT

OTHER

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

Behavioral: Physical therapy

Group exercise class

OTHER

The participant will be in a group exercise class. That will meet 3 days a week for 4 weeks.

Behavioral: Group Exercise Class

Home Program

OTHER

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

Interventions

Physical therapy program for people with PD--one on one with a PT

One on one with a PT

The participant will be in an exercise class for 3 days a week for 4 weeks.

Group exercise class
Home ProgramBEHAVIORAL

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.

Home Program

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Idiopathic Parkinson's disease

You may not qualify if:

  • Outside of the age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Laurie King, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 27, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations