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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual
Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University
Boston, Massachusetts, United States
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.
Time frame: 6-7 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-7 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.