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Sensory Attention Focused Exercise in Parkinson's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Sun Life Financial Movement Disorders Research and Rehabilitation Centre.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246700
First Posted: November 23, 2010
Last Update Posted: November 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention
Parkinson's Disease Other: Sensory Attention Focused Exercise (SAFEx)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensory Attention Focused Exercise in Parkinson's Disease: A Randomized Double-Crossover Trial.

Resource links provided by NLM:


Further study details as provided by Sun Life Financial Movement Disorders Research and Rehabilitation Centre:

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score) [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    Assessment of patient's disease severity, completed by a blinded certified clinician.


Secondary Outcome Measures:
  • Timed up and go [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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 ]
    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 ]
    Participants complete a self-report questionnaire, and rank how they are feeling.

  • Grooved Pegboard [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    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 ]
    Measured using GAITRite software.

  • Velocity [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    Assessed using GAITRite software.

  • Step to Step Length Variability [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    Assessed using GAITRite software.


Enrollment: 76
Study Start Date: June 2008
Estimated Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Participants received 12 weeks of Sensory Attention Focused Exercise, then received 12 weeks of no exercise.
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.

Experimental: Group B
Participants received no treatment for 12 weeks, then received Sensory Attention Focused Exercise 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.


Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT01246700


Locations
Canada, Ontario
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Waterloo, Ontario, Canada, N2L 3J4
Sponsors and Collaborators
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)
Investigators
Study Director: Quincy J Almeida, Ph.D Sun Life Financial Movement Disorders Research and Rehabilitation Centre
  More Information

Additional Information:
Publications:
Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01246700     History of Changes
Other Study ID Numbers: 225510
First Submitted: November 22, 2010
First Posted: November 23, 2010
Last Update Posted: November 23, 2010
Last Verified: September 2010

Keywords provided by Sun Life Financial Movement Disorders Research and Rehabilitation Centre:
Parkinson's disease
Randomized single-blind crossover trial
Sensory Attention Focused Exercise

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