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Completed

NCT Number: NCT02302144

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance & Strengthening Exercises

Behavioral

Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 26, 2014
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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