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

Boston University Charles River Campus

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: Balance & Strengthening Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT02302144

BU-SAR-BAL

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Early Multi-Ex-PD

Experimental group

Description:

Immediately following enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests.

Treatment:

Behavioral: Balance & Strengthening Exercises

Late Multi-Ex-PD

Experimental group

Description:

Three months after enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests.

Treatment:

Behavioral: Balance & Strengthening Exercises