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Evaluating the Influence of Externally vs. Internally Focused Exercise on Rehabilitation in Parkinson's Disease (DT-PDSAFEx)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parkinson's disease Sensory Attention Focused Exercise
Sponsored by
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Exercise, Attention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Either gender, no age or location restriction
  • Diagnosed with idiopathic Parkinson's disease by a Neurologist
  • Able to stand 2 minutes, unassisted
  • Able to walk 10 meters, unassisted
  • Able to understand English instructions

Exclusion Criteria:

  • A neurological disease other than Parkinson's disease
  • Peripheral neuropathy
  • Clinically diagnosed with dementia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    No Intervention

    Arm Label

    Internally Focused PD-SAFEx

    Externally Focused PD-SAFEx

    Control Group

    Arm Description

    While performing the exercises in PD-SAFEx™, participants will be instructed to focus their attention on sensory feedback. This will include focusing participants' attention on the stretch in their limbs while walking, on the straightness of their backs while sitting, on limb and body orientation in space while coordinating their movements, and on chest movements during breathing exercises. Throughout each exercise session, the instructor and volunteers will constantly provide attention-directing instructions.

    While performing the exercises from the PD-SAFEx™ program, participants will be instructed to focus their attention externally on the movement of coloured labels attached to their feet, knees, elbows and hands. Participants will be reminded and encouraged by the exercise instructor and volunteers to perform all exercises while focusing attention on the labels.

    This group will be asked to refrain from changing activities of their daily lives throughout the 20-week duration of the experiment (from pre-assessment to washout).

    Outcomes

    Primary Outcome Measures

    Unified Parkinson's disease Rating Scale Part III (UPDRS-III)
    A physical movement assessment to quantify Parkinson's disease symptom severity. This is a non-invasive, risk free, painless examination.
    UPDRS-III
    A physical movement assessment to quantify Parkinson's disease symptom severity. This is a non-invasive, risk free, painless examination.
    Single and Dual Task Walking
    Participants will be asked to walk along a 9.75m long and 0.61m wide ProtoKinetics Movement Analysis Software™ electronic walkway carpet (Zeno Walkway - ProtoKinetics, Havertown, PA, USA). This electronic walkway will measure spatiotemporal characteristics of the individuals' gait while they walk with and without the performance of a dual task. The dual task that will be performed by the participants with Parkinson's disease will be a phoneme monitoring dual task not trained in the intervention. Participants will be asked to complete 3 trials of each condition.
    Single Task and Dual Task Walking
    Participants will be asked to walk along a 9.75m long and 0.61m wide ProtoKinetics Movement Analysis Software™ electronic walkway carpet (Zeno Walkway - ProtoKinetics, Havertown, PA, USA). This electronic walkway will measure spatiotemporal characteristics of the individuals' gait while they walk with and without the performance of a dual task. The dual task that will be performed by the participants with Parkinson's disease will be a phoneme monitoring dual task not trained in the intervention. Participants will be asked to complete 3 trials of each condition.
    Parkinson Anxiety Scale Questionnaire
    Valid measure of persistent, episodic, and avoidance behaviour anxiety
    Parkinson Anxiety Scale Questionnaire
    Valid measure of persistent, episodic, and avoidance behaviour anxiety

    Secondary Outcome Measures

    Measures of Executive Function
    To measure general cognitive status, the Montreal Cognitive Assessment will be completed.
    Measures of Executive Function
    To measure general cognitive status, the Montreal Cognitive Assessment will be completed.
    Parkinson's disease Questionnaire 39
    A validated questionnaire for individuals with Parkinson's disease to address well-being and perceived quality of life.
    Parkinson's disease Questionnaire 39
    A validated questionnaire for individuals with Parkinson's disease to address well-being and perceived quality of life.
    Community Health Activities Model Program for Seniors questionnaire (CHAMPS)
    To determine whether the control group changes in physical activity level throughout the duration of the present study
    CHAMPS
    To determine whether the control group changes in physical activity level throughout the duration of the present study

    Full Information

    First Posted
    June 16, 2015
    Last Updated
    August 30, 2017
    Sponsor
    Sun Life Financial Movement Disorders Research and Rehabilitation Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02476240
    Brief Title
    Evaluating the Influence of Externally vs. Internally Focused Exercise on Rehabilitation in Parkinson's Disease
    Acronym
    DT-PDSAFEx
    Official Title
    Can Dual Task Walking Improve in Parkinson's Disease After External Focus of Attention Exercise? A Single Blind Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Life Financial Movement Disorders Research and Rehabilitation Centre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the underlying mechanism and influence of externally vs. internally focused exercise on rehabilitation in Parkinson's disease. The upcoming exercise intervention methodology will aim to meet the requirements of a 1A silver ranking level, single blind, randomized control trial according to the criterion of the Cochrane Musculoskeletal Review Group
    Detailed Description
    Parkinson's disease is a slow progressing neurodegenerative movement disorder with both motor and non-motor symptoms. The gold standard medical pharmacotherapy (levodopa) lends relief from symptoms. However, some of the non-motor symptoms are not responsive to this therapy or eventually become non-responsive, such as impaired proprioception (sensory feedback from the limbs providing awareness of one's body in physical space). Although it is unclear as to why levodopa is unable to relieve proprioception impairments, a key underlying mechanism that may be responsible is an impaired sensorimotor integration (the combination of sensory and motor information in the brain utilized to guide movements). This is not the result of corrupted input information from proprioceptors into the brain (such as muscle spindles and golgi tendon organs), but rather the downstream integration of this information in the brain. With faulty signalling through the area of the brain damaged in Parkinson's disease (the basal ganglia), deficient sensorimotor integration impairs patients' ability to rely on sensory feedback during movement. This subsequently impairs ability to automatize learned movements in Parkinson's disease and causes previously automatic movements (such as walking) to require conscious control (lose automaticity). This is problematic in instances where attention is diverted from a movement that is no longer automatically controlled, such as engaging in a conversation while walking. Without attention on the movement, motor control breaks down, leading to heightened chance of falls and injury. However, Wulf and Colleagues (2009) demonstrated that when individuals with Parkinson's disease focused externally, and greater reliance on sensorimotor integration was fostered, balance control was improved compared to when these individuals focused attention internally. This suggests that individuals with Parkinson's disease may retain ability to rely on sensorimotor integration. Therefore, by fostering neuroplasticity through the basal ganglia with the utilization of exercise, and improving ability to rely on sensorimotor integration in individuals with Parkinson's disease (by using dual task training), automaticity of movements may be improved, subsequently decreasing the risk of falling and injury. Furthermore, by improving sensorimotor integration, symptom severity might improve and disease progression may slow. In addition to providing improvements to symptoms of Parkinson's disease, this will provide a greater understanding into the pathophysiological mechanisms underlying improvements associated with exercise rehabilitations employed for Parkinson's disease. To date, goal-directed exercises have yet to investigate the rudimentary aspects of the exercise, since no studies have directly compared identical exercise regimens while participants focus "internally" on the movements of their limbs compared to focusing "externally" on the movement of an object that is being manipulated. For this reason, this study will investigate large magnitude gait and balance training in two groups, one focusing internally on limb movements throughout the exercise program, and the other focusing externally on the movement of coloured labels attached to their limbs. The gait, balance, stretching and coordination exercises that will be provided in the proposed intervention to the two exercise groups will follow the exact Parkinson's disease Sensory Attention Focused Exercise (PD-SAFEx™) protocol designed by Sage and Almeida (2009). PD-SAFEx™ is a group setting intervention, which will be led by the primary investigator who is trained in conducting the exercise protocol. The first half of the exercise class will include walking exercises that include large magnitude and coordinated movements. All walking will be performed slowly. Walking exercises will be followed by balance, stretching, and coordination exercises while sitting in, or standing near, standard office chairs, utilizing latex Thera-bands®. To ensure that balance and coordination are constantly challenged throughout the intervention, the exercise program progresses each week, increasing in difficulty. Sixty-five participants diagnosed with idiopathic Parkinson's disease will be recruited. This present intervention study will span over a 20- week period. Pre-assessments to measure baseline symptoms and functionality will be conducted over the initial 2-week period prior to the start of the intervention. After pre-assessments have been conducted, participants will be randomized to one of three groups: Group 1: Internal Focus of attention Exercise (Original PD-SAFEx™) While performing the exercises in PD-SAFEx™, participants will be instructed to focus their attention on sensory feedback. This will include focusing participants' attention on the stretch in their limbs while walking, on the straightness of their backs while sitting, on limb and body orientation in space while coordinating their movements, and on chest movements during breathing exercises. Throughout each exercise session, the instructor and volunteers will constantly provide attention-directing instructions. Group 2: External Focus of attention Exercise (Modified PD-SAFEx™) While performing the exercises from the PD-SAFEx™ program, participants will be instructed to focus their attention towards the movement of coloured labels attached to their hands, elbows, knees and feet. Group 3: Control Group This group will be asked to refrain from changing activities of their daily lives throughout the 20-week duration of the experiment (from pre-assessment to washout). The exercise program will follow the pre-assessment baseline measures, and will last 12 weeks. Each exercise session will last 60 minutes, and will be provided three times per week. Post-assessment of all outcome measures tested prior to the intervention will be assessed in a 2-week period immediately after the cessation of the exercise program. The washout period will last 6 weeks; thereafter assessments will be completed again. Since the present research study aims to understand the mechanism underlying these rehabilitations, as well as ensure ecological validity, symptom severity (UPDRS-III) will be assessed in all individuals in both the "ON" and "OFF" state of dopaminergic medication. Since the individuals are in the "ON" state during all daily activities, exercise classes will be performed in the "ON" dopaminergic medication state. If there are individuals who are naïve to dopaminergic medication (De novo), they will only be assessed once (in the "OFF" dopaminergic state). All individuals included in the rehabilitation program will be required to complete a Physical Activity Readiness Medical Examination (ParMed X), signed by a physician prior to joining the rehabilitation program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Exercise, Attention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Internally Focused PD-SAFEx
    Arm Type
    Active Comparator
    Arm Description
    While performing the exercises in PD-SAFEx™, participants will be instructed to focus their attention on sensory feedback. This will include focusing participants' attention on the stretch in their limbs while walking, on the straightness of their backs while sitting, on limb and body orientation in space while coordinating their movements, and on chest movements during breathing exercises. Throughout each exercise session, the instructor and volunteers will constantly provide attention-directing instructions.
    Arm Title
    Externally Focused PD-SAFEx
    Arm Type
    Experimental
    Arm Description
    While performing the exercises from the PD-SAFEx™ program, participants will be instructed to focus their attention externally on the movement of coloured labels attached to their feet, knees, elbows and hands. Participants will be reminded and encouraged by the exercise instructor and volunteers to perform all exercises while focusing attention on the labels.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    This group will be asked to refrain from changing activities of their daily lives throughout the 20-week duration of the experiment (from pre-assessment to washout).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Parkinson's disease Sensory Attention Focused Exercise
    Other Intervention Name(s)
    PD-SAFEx
    Intervention Description
    The first half of the exercise class will include walking exercises that include large magnitude and coordinated movements. All walking will be performed slowly. Walking exercises will be followed by balance, stretching, and coordination exercises while sitting in, or standing near, standard office chairs, utilizing latex Thera-bands®. To ensure that balance and coordination are constantly challenged throughout the intervention, the exercise program progresses each week, increasing in difficulty. Depending on the task, the first set of each exercise will be performed with 'eyes-open' to familiarize participants with the task, and subsequent sets will be performed with 'eyes-closed'. If there is only one set for a specific exercise, the first half of the repetitions will be performed with 'eyes-open' and the second half with 'eyes-closed'.
    Primary Outcome Measure Information:
    Title
    Unified Parkinson's disease Rating Scale Part III (UPDRS-III)
    Description
    A physical movement assessment to quantify Parkinson's disease symptom severity. This is a non-invasive, risk free, painless examination.
    Time Frame
    Pre-assessment to post-assessment (12 weeks)
    Title
    UPDRS-III
    Description
    A physical movement assessment to quantify Parkinson's disease symptom severity. This is a non-invasive, risk free, painless examination.
    Time Frame
    Post-assessment to Washout (8 weeks)
    Title
    Single and Dual Task Walking
    Description
    Participants will be asked to walk along a 9.75m long and 0.61m wide ProtoKinetics Movement Analysis Software™ electronic walkway carpet (Zeno Walkway - ProtoKinetics, Havertown, PA, USA). This electronic walkway will measure spatiotemporal characteristics of the individuals' gait while they walk with and without the performance of a dual task. The dual task that will be performed by the participants with Parkinson's disease will be a phoneme monitoring dual task not trained in the intervention. Participants will be asked to complete 3 trials of each condition.
    Time Frame
    Pre-assessment to Post-assessment (12 weeks)
    Title
    Single Task and Dual Task Walking
    Description
    Participants will be asked to walk along a 9.75m long and 0.61m wide ProtoKinetics Movement Analysis Software™ electronic walkway carpet (Zeno Walkway - ProtoKinetics, Havertown, PA, USA). This electronic walkway will measure spatiotemporal characteristics of the individuals' gait while they walk with and without the performance of a dual task. The dual task that will be performed by the participants with Parkinson's disease will be a phoneme monitoring dual task not trained in the intervention. Participants will be asked to complete 3 trials of each condition.
    Time Frame
    Post-assessment to washout (8 weeks)
    Title
    Parkinson Anxiety Scale Questionnaire
    Description
    Valid measure of persistent, episodic, and avoidance behaviour anxiety
    Time Frame
    Pre-assessment to Post-assessment (12 weeks)
    Title
    Parkinson Anxiety Scale Questionnaire
    Description
    Valid measure of persistent, episodic, and avoidance behaviour anxiety
    Time Frame
    Post-assessment to washout (8 weeks)
    Secondary Outcome Measure Information:
    Title
    Measures of Executive Function
    Description
    To measure general cognitive status, the Montreal Cognitive Assessment will be completed.
    Time Frame
    Pre-assessment to post-assessment (12 weeks)
    Title
    Measures of Executive Function
    Description
    To measure general cognitive status, the Montreal Cognitive Assessment will be completed.
    Time Frame
    Post-assessment to Washout (8 weeks)
    Title
    Parkinson's disease Questionnaire 39
    Description
    A validated questionnaire for individuals with Parkinson's disease to address well-being and perceived quality of life.
    Time Frame
    Pre-assessment to Post-assessment (12 weeks)
    Title
    Parkinson's disease Questionnaire 39
    Description
    A validated questionnaire for individuals with Parkinson's disease to address well-being and perceived quality of life.
    Time Frame
    Post-assessment to washout (8 weeks)
    Title
    Community Health Activities Model Program for Seniors questionnaire (CHAMPS)
    Description
    To determine whether the control group changes in physical activity level throughout the duration of the present study
    Time Frame
    Pre-assessment to post-assessment (12 weeks)
    Title
    CHAMPS
    Description
    To determine whether the control group changes in physical activity level throughout the duration of the present study
    Time Frame
    Post-assessment to washout (8 weeks)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Either gender, no age or location restriction Diagnosed with idiopathic Parkinson's disease by a Neurologist Able to stand 2 minutes, unassisted Able to walk 10 meters, unassisted Able to understand English instructions Exclusion Criteria: A neurological disease other than Parkinson's disease Peripheral neuropathy Clinically diagnosed with dementia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Quincy J Almeida, PhD
    Organizational Affiliation
    Sun Life Financial Movement Disorders Research and Rehabilitation Centre, Wilfrid Laurier University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    19074619
    Citation
    Wulf G, Landers M, Lewthwaite R, Tollner T. External focus instructions reduce postural instability in individuals with Parkinson disease. Phys Ther. 2009 Feb;89(2):162-8. doi: 10.2522/ptj.20080045. Epub 2008 Dec 12.
    Results Reference
    background
    PubMed Identifier
    19373930
    Citation
    Sage MD, Almeida QJ. Symptom and gait changes after sensory attention focused exercise vs aerobic training in Parkinson's disease. Mov Disord. 2009 Jun 15;24(8):1132-8. doi: 10.1002/mds.22469.
    Results Reference
    background

    Learn more about this trial

    Evaluating the Influence of Externally vs. Internally Focused Exercise on Rehabilitation in Parkinson's Disease

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