A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02302144
• Date of registration: 24/11/2014
• Prospective Registration: No
• Primary sponsor: Boston University Charles River Campus
• Public title: A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
• Scientific title: A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
• Date of first enrolment: December 2011
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02302144
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Terry Ellis, PhD, PT, NCS
• Affiliation: Boston University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Behavioral: Balance & Strengthening Exercises

Primary Outcome(s)

Falls Diary [Time Frame: 6-7 Months]

Secondary Outcome(s)

Changes in Beck Depression Inventory Second Edition [Time Frame: 6-7 Months]

Change in Beck Anxiety Inventory [Time Frame: 6-7 Months]

Change in Unified Parkinson's Disease Rating Scale [Time Frame: 6-7 Months]

Change in Parkinson's Disease Questionnaire-39 [Time Frame: 6-7 Months]

Change in Scales for Outcomes in Parkinson Disease [Time Frame: 6-7 Months]

Change in Panic Disorder Severity Scale [Time Frame: 6-7 Months]

Change in Six-Minute Walk Test [Time Frame: 6-7 Months]

Changes in Social Interaction Anxiety Scale [Time Frame: 6-7 Months]

Change in Activities-specific Balance Confidence [Time Frame: 6-7 Months]

Change in Falls Self-Efficacy [Time Frame: 6-7 Months]

Change in Freezing of Gait Questionnaire [Time Frame: 6-7 Months]

Changes in Penn State Worry Questionnaire [Time Frame: 6-7 Months]

Changes in Social Phobia Inventor [Time Frame: 6-7 Months]

Change in Balance Evaluation Systems Test (BESTest) [Time Frame: 6-7 Months]

Changes in Anxiety Sensitivity Index [Time Frame: 6-7 Months]

Secondary ID(s)

BU-SAR-BAL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors