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Sensory Attention Focused Exercise in Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Sun Life Financial Movement Disorders Research and Rehabilitation Centre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Canada, Young Men's Christian Association (YMCA)
Parkinson Society Canada
Canada, Sun Life Financial
Canadian Institutes of Health Research (CIHR)
Information provided by:
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
ClinicalTrials.gov Identifier:
NCT01246700
First received: November 22, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

November 22, 2010
November 22, 2010
June 2008
December 2009   (final data collection date for primary outcome measure)
Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score) [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
Assessment of patient's disease severity, completed by a blinded certified clinician.
Same as current
No Changes Posted
  • Timed up and go [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Participants stand out of a chair, walk 3 meters, turn around and sit back down. This task is timed.
  • 30 second chair stand [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Participants instructed to stand from a seated position as many times as possible in 30 seconds. Number of completed stands is recorded.
  • Unified Parkinson's Disease Rating Scale (UPDRS) - I and II (self report of mentation, depression, and activities of daily living). [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Participants complete a self-report questionnaire, and rank how they are feeling.
  • Grooved Pegboard [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Participants must place and remove 25 pegs as fast as possible using a standard Grooved Pegboard. Participants are timed.
  • Step Length [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Measured using GAITRite software.
  • Velocity [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Assessed using GAITRite software.
  • Step to Step Length Variability [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Assessed using GAITRite software.
Same as current
Not Provided
Not Provided
 
Sensory Attention Focused Exercise in Parkinson's Disease
Sensory Attention Focused Exercise in Parkinson's Disease: A Randomized Double-Crossover Trial.

The purpose of this study is 1.) to determine if sensory attention focused exercise is an effective management strategy for Parkinson's disease, and 2.) to identify if the benefits are a result of strength gains.

Currently, there is no cure for Parkinson's disease (PD) and although medication offers symptom reduction, there are many negative side effects associated with medication use. Thus, there has been an increased emphasis on exercise interventions for symptom reduction. Recent research has shown that both sensory attention focused exercise (SAFEx) and strength training interventions improved disease severity more so than other exercise interventions (such as aerobic, aquatic and no exercise). Upon closer examination, SAFEx showed further symptom improvements than the strength training program. Thus exists the need to further examine SAFEx using a standardized protocol - a single-blind randomized double-crossover trial - that has been used sparingly in exercise interventions. In addition, the 30-second chair stand has been implemented into the testing protocol, as it has been shown to be a reliable measurement of functional strength for older adults. This test was implemented in order to identify the functional strength gains, if any, that are associated with SAFEx. It is hypothesized that the SAFEx intervention will improve disease symptoms in PD, and that the results will not be due to strength gains.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Other: Sensory Attention Focused Exercise (SAFEx)

    Consisted of 12 weeks for SAFEx intervention, 3 times a week for an hour each session. Participants complete dynamic balance activities and a variety of seated stretches and range of motion activities. Participants are cued to focus on sensation and proprioception of limbs.

    Group A received SAFEx for 12 weeks then received no treatment for 12 weeks.

  • Other: Sensory Attention Focused Exercise (SAFEx)

    Consisted of 12 weeks for SAFEx intervention, 3 times a week for an hour each session. Participants complete dynamic balance activities and a variety of seated stretches and range of motion activities. Participants are cued to focus on sensation and proprioception of limbs.

    Group B received no treatment for 12 weeks, then received SAFEx for 12 weeks.

  • Experimental: Group A
    Participants received 12 weeks of Sensory Attention Focused Exercise, then received 12 weeks of no exercise.
    Intervention: Other: Sensory Attention Focused Exercise (SAFEx)
  • Experimental: Group B
    Participants received no treatment for 12 weeks, then received Sensory Attention Focused Exercise for 12 weeks.
    Intervention: Other: Sensory Attention Focused Exercise (SAFEx)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
76
December 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of PD by a clinician/neurologist
  • absence of mentation
  • established medication schedule and dosage

Exclusion Criteria:

  • mentation
  • change in medication during period of study
  • change in exercise level during period of study
  • inability to complete the exercise program
  • absence of 5 or more classes, or absence of 3 or more classes in sequence
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01246700
225510
No
Dr. Quincy Almeida; Director of Sun Life Financial Movement Disorders Research and Rehabilitation Centre, Sun Life Financial Movement Disorders Research and Rehabilitation Centre; Wilfrid Laurier University
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
  • Canada, Young Men's Christian Association (YMCA)
  • Parkinson Society Canada
  • Canada, Sun Life Financial
  • Canadian Institutes of Health Research (CIHR)
Study Director: Quincy J Almeida, Ph.D Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP