A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Boston University Charles River Campus
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Falls Diary
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Theresa D Ellis
Assistant Professor and Director of Center for Neurorehabilitation
Boston University
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
Outcomes
Primary Outcomes
Falls Diary
Time Frame: 6-7 Months
Subjects will be asked to record each falling episode in the falls diary at the time of the fall or as soon as possible in relation to the actual time that the fall occurred. Subjects will be interviewed regarding fall episodes at each treatment session.
Secondary Outcomes
- Change in Six-Minute Walk Test(6-7 Months)
- Change in Scales for Outcomes in Parkinson Disease(6-7 Months)
- Change in Panic Disorder Severity Scale(6-7 Months)
- Changes in Social Interaction Anxiety Scale(6-7 Months)
- Change in Unified Parkinson's Disease Rating Scale(6-7 Months)
- Change in Falls Self-Efficacy(6-7 Months)
- Change in Parkinson's Disease Questionnaire-39(6-7 Months)
- Changes in Beck Depression Inventory Second Edition(6-7 Months)
- Changes in Penn State Worry Questionnaire(6-7 Months)
- Change in Activities-specific Balance Confidence(6-7 Months)
- Change in Freezing of Gait Questionnaire(6-7 Months)
- Change in Beck Anxiety Inventory(6-7 Months)
- Change in Balance Evaluation Systems Test (BESTest)(6-7 Months)
- Changes in Anxiety Sensitivity Index(6-7 Months)
- Changes in Social Phobia Inventor(6-7 Months)