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

Study 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.

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

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Behavioral: Balance & Strengthening Exercises


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Multi-Ex-PD<br>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<br>* Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual<br>|
| Experimental: Late Multi-Ex-PD<br>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<br>* Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls Diary | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postural Instability (falling), Gait Disturbances (e.g., freezing), Bradykinesia (slowness of movement), rigidity