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

July 18, 2017 updated by: Theresa D Ellis, Boston University Charles River Campus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Multi-Ex-PD
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.
Behavioral: Balance & Strengthening Exercises
Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual
Experimental: Late Multi-Ex-PD
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.
Behavioral: Balance & Strengthening Exercises
Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-7 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Activities-specific Balance Confidence
Time Frame: 6-7 Months
Activities-specific Balance Confidence (ABC) Scale is a self-administered questionnaire in which subjects rate their level of confidence in performing a series of 16 activities.
6-7 Months
Change in Falls Self-Efficacy
Time Frame: 6-7 Months
The Falls Self-Efficacy Scale is a self-administered questionnaire in which subjects rate their level of concern about falling when performing designated activities.
6-7 Months
Change in Balance Evaluation Systems Test (BESTest)
Time Frame: 6-7 Months
The Balance Evaluation Systems Test (BESTest) is a 36 item test which is used to assess postural control / balance. Subjects are asked to perform a series of tasks such as sitting and leaning, standing on compliant and noncompliant surfaces, stepping forward, backward and to the side and walking on level and unlevel surfaces, while turning the head and while negotiating obstacles.
6-7 Months
Change in Six-Minute Walk Test
Time Frame: 6-7 Months
The six-minute walk test (6MWT) is a measure of the distance a participant walks in a 6 minute time period. The 6-minute walk test is a safe, simple and useful measure of walking ability in patients with Parkinson's disease. The test will be carried out on level, obstacle-free enclosed corridors.
6-7 Months
Change in Freezing of Gait Questionnaire
Time Frame: 6-7 Months
The Freezing of Gait Questionnaire (FOG) is a 6-item test in which the patient is interviewed and asked questions about their walking ability.
6-7 Months
Change in Unified Parkinson's Disease Rating Scale
Time Frame: 6-7 Months
Section I, II, III and IV of the Unified Parkinson's Disease Rating Scale (UPDRS) will be utilized to assess nonmotor and motor signs.
6-7 Months
Change in Scales for Outcomes in Parkinson Disease
Time Frame: 6-7 Months
The Scales for Outcomes in Parkinson Disease (SCOPA-AUT) consists of 26 items assessing autonomic function including gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillomotor and sexual function.
6-7 Months
Change in Parkinson's Disease Questionnaire-39
Time Frame: 6-7 Months
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a quality of life instrument that contains 39-self-report items and was specifically developed for people with Parkinson's disease. The PDQ-39 measures the degree of healthy, competent, and satisfying participation in daily life activities.
6-7 Months
Change in Beck Anxiety Inventory
Time Frame: 6-7 Months
The Beck Anxiety Inventory (BAI) is a measure of the severity of anxiety in adolescents and adults. The items assess typical features of anxiety, and the measure.
6-7 Months
Changes in Beck Depression Inventory Second Edition
Time Frame: 6-7 Months
The Beck Depression Inventory Second Edition (BDI-II) is a measure of the severity of depression in adolescents and adults. The items target common symptoms of depression.
6-7 Months
Changes in Penn State Worry Questionnaire
Time Frame: 6-7 Months
The Penn State Worry Questionnaire (PSWQ) is a measure of the worry characteristic of generalized anxiety disorder (GAD). Specifically, this measure of pathological worry assesses three areas of worry (generality, excessiveness, and uncontrollability).
6-7 Months
Change in Panic Disorder Severity Scale
Time Frame: 6-7 Months
The Panic Disorder Severity Scale (PDSS) is a questionnaire designed to measure the overall severity of panic disorder. The items assess the severity of seven dimensions of panic disorder and associated symptoms: frequency of panic attacks, distress during panic attacks, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, and impairment and interference in work and social functioning.
6-7 Months
Changes in Anxiety Sensitivity Index
Time Frame: 6-7 Months
The Anxiety Sensitivity Index (ASI) is an instrument on which respondents rate the degree to which they fear negative consequences resulting from anxiety symptoms. It yields a total score, representing the global-order anxiety sensitivity factor, as well as three lower-order factor scores, representing physical, psychological, and social concerns.
6-7 Months
Changes in Social Phobia Inventor
Time Frame: 6-7 Months
The Social Phobia Inventory (SPIN) is a self-report questionnaire used to measure symptoms of social phobia (or social anxiety disorder). The SPIN specifically evaluates the spectrum of fear (e.g. fear of being embarrassed), avoidance (e.g. avoidance of parties), and physiological (e.g. blushing) symptoms associated with social phobia.
6-7 Months
Changes in Social Interaction Anxiety Scale
Time Frame: 6-7 Months
The Social Interaction Anxiety Scale (SIAS) is a self-report questionnaire used to measure general fears of social interaction and fears of being scrutinized during activities and performance tasks. The scale is intended to measure affective, behavioral, and cognitive reactions in 20 social interaction situations.
6-7 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Investigators

  • Principal Investigator: Terry Ellis, PhD, PT, NCS, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU-SAR-BAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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