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

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ClinicalTrials.gov Identifier: NCT02476240
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Eric Beck, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Parkinson's disease Sensory Attention Focused Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Dual Task Walking Improve in Parkinson's Disease After External Focus of Attention Exercise? A Single Blind Randomized Controlled Trial
Study Start Date : August 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Internally Focused 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.
Behavioral: Parkinson's disease Sensory Attention Focused Exercise
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'.
Other Name: PD-SAFEx

Experimental: Externally Focused PD-SAFEx
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.
Behavioral: Parkinson's disease Sensory Attention Focused Exercise
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'.
Other Name: PD-SAFEx

No Intervention: 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).



Primary Outcome Measures :
  1. Unified Parkinson's disease Rating Scale Part III (UPDRS-III) [ Time Frame: Pre-assessment to post-assessment (12 weeks) ]
    A physical movement assessment to quantify Parkinson's disease symptom severity. This is a non-invasive, risk free, painless examination.

  2. UPDRS-III [ Time Frame: Post-assessment to Washout (8 weeks) ]
    A physical movement assessment to quantify Parkinson's disease symptom severity. This is a non-invasive, risk free, painless examination.

  3. Single and Dual Task Walking [ Time Frame: Pre-assessment to Post-assessment (12 weeks) ]
    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.

  4. Single Task and Dual Task Walking [ Time Frame: Post-assessment to washout (8 weeks) ]
    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.

  5. Parkinson Anxiety Scale Questionnaire [ Time Frame: Pre-assessment to Post-assessment (12 weeks) ]
    Valid measure of persistent, episodic, and avoidance behaviour anxiety

  6. Parkinson Anxiety Scale Questionnaire [ Time Frame: Post-assessment to washout (8 weeks) ]
    Valid measure of persistent, episodic, and avoidance behaviour anxiety


Secondary Outcome Measures :
  1. Measures of Executive Function [ Time Frame: Pre-assessment to post-assessment (12 weeks) ]
    To measure general cognitive status, the Montreal Cognitive Assessment will be completed.

  2. Measures of Executive Function [ Time Frame: Post-assessment to Washout (8 weeks) ]
    To measure general cognitive status, the Montreal Cognitive Assessment will be completed.

  3. Parkinson's disease Questionnaire 39 [ Time Frame: Pre-assessment to Post-assessment (12 weeks) ]
    A validated questionnaire for individuals with Parkinson's disease to address well-being and perceived quality of life.

  4. Parkinson's disease Questionnaire 39 [ Time Frame: Post-assessment to washout (8 weeks) ]
    A validated questionnaire for individuals with Parkinson's disease to address well-being and perceived quality of life.

  5. Community Health Activities Model Program for Seniors questionnaire (CHAMPS) [ Time Frame: Pre-assessment to post-assessment (12 weeks) ]
    To determine whether the control group changes in physical activity level throughout the duration of the present study

  6. CHAMPS [ Time Frame: Post-assessment to washout (8 weeks) ]
    To determine whether the control group changes in physical activity level throughout the duration of the present study



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476240


Sponsors and Collaborators
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Investigators
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Study Director: Quincy J Almeida, PhD Sun Life Financial Movement Disorders Research and Rehabilitation Centre, Wilfrid Laurier University

Publications:
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Responsible Party: Eric Beck, Graduate Student, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
ClinicalTrials.gov Identifier: NCT02476240     History of Changes
Other Study ID Numbers: 3983
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Eric Beck, Sun Life Financial Movement Disorders Research and Rehabilitation Centre:
Exercise
Attention

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases