Clinical trial NCT02302144: A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
Official title: A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Postural Instability (falling)
Gait Disturbances (e.g., freezing)
Bradykinesia (slowness of movement), rigidity
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease.

In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be randomly assigned to either an early start (immediately following enrollment) or late start (3 months after enrollment) multifactorial exercise program which will meet 2 times per week for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening exercises which will be individualized depending on the ability of each participant. Fall rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be enrolled for 6-7 months.


Eligibility criteria: Inclusion Criteria:

* have a diagnosis of idiopathic Parkinson's disease (using UK Brain Bank Criteria)
* have a Hoehn \& Yahr stage of 2-4 during the "ON" state
* Mini mental status score \> 26
* be 40 years of age or older, so as to represent the typical age range of PD
* be on a stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 3 month study period.
* have experienced at least one fall in the past 3 months and greater or equal to 2 falls in the past one-year (A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level not due to a major intrinsic or extrinsic event)
* able to walk without physical assistance or an assistive device for at least 5 continuous minutes
* able to understand, communicate with and be understood by recruitment personnel
* able to attend the exercise program twice per week at Sargent College
* be interested in participating and provide informed consent

Exclusion Criteria:

* have a diagnosis of atypical Parkinsonism
* have a Hoehn \& Yahr stage of 1 or 5
* have had previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
* serious co-morbidities that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))
* be pregnant

Primary outcomes:
measure: Falls Diary
timeFrame: 6-7 Months
Secondary outcomes:
measure: Change in Activities-specific Balance Confidence
timeFrame: 6-7 Months
measure: Change in Falls Self-Efficacy
timeFrame: 6-7 Months
measure: Change in Balance Evaluation Systems Test (BESTest)
timeFrame: 6-7 Months
measure: Change in Six-Minute Walk Test
timeFrame: 6-7 Months
measure: Change in Freezing of Gait Questionnaire
timeFrame: 6-7 Months
measure: Change in Unified Parkinson's Disease Rating Scale
timeFrame: 6-7 Months
measure: Change in Scales for Outcomes in Parkinson Disease
timeFrame: 6-7 Months
measure: Change in Parkinson's Disease Questionnaire-39
timeFrame: 6-7 Months
measure: Change in Beck Anxiety Inventory
timeFrame: 6-7 Months
measure: Changes in Beck Depression Inventory Second Edition
timeFrame: 6-7 Months
measure: Changes in Penn State Worry Questionnaire
timeFrame: 6-7 Months
measure: Change in Panic Disorder Severity Scale
timeFrame: 6-7 Months
measure: Changes in Anxiety Sensitivity Index
timeFrame: 6-7 Months
measure: Changes in Social Phobia Inventor
timeFrame: 6-7 Months
measure: Changes in Social Interaction Anxiety Scale
timeFrame: 6-7 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Terry Ellis, PhD, PT, NCS
role: PRINCIPAL_INVESTIGATOR
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